Meds A-Z

Flunixin Meglumine

Detailed information about Flunixin Meglumine

Official label facts Owner quick guide first Marketing clearly labeled

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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Flunine-S™ · official_label
openFDA case USA-USFDACVM-2019-US-025839 · adverse_reaction

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of BRD-associated pyrexia in beef and non-lactatin...

What to watch for:

Not for use in horses intended for food
Do not slaughter for human consumption within 4 days of last treatment
A withdrawal period has not been established for use in preruminating calves
Do not use in calves to be processed for veal
Do not use in dry dairy cows
Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food
Approved only for intravenous administration in cattle
Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter
Swine must not be slaughtered for human consumption within 12 days of last treatment
very low energy (1 reports)
Surgical site disorder (1 reports)
Shaking (1 reports)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.
Facial swelling or hives.
Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to ask your vet today:

Is this medicine the right fit for my pet’s current symptoms?
Which warning signs mean I should call back right away?
How should I handle missed doses or refusal to take the medicine?

Safety & side effects

What to watch:

Not for use in horses intended for food
Do not slaughter for human consumption within 4 days of last treatment
A withdrawal period has not been established for use in preruminating calves
Do not use in calves to be processed for veal
Do not use in dry dairy cows

Most reported reactions:

Tiredness (lethargy) (1 reports)
Surgical site disorder (1 reports)
Shaking (1 reports)

When to call your vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness

Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:15 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

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Flunixin Meglumine

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Intervet, Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both

Manufacturer: Intervet, Inc.

Form: Injectable Solution, Liquid (Solution), Paste, Top Dressing In Feed

Identifiers:

ANADA: 200061 ANADA: 200124 ANADA: 200142 ANADA: 200387 ANADA: 200476 ANADA: 200489 ANADA: 200581 ANADA: 200781 ANADA: 200791 ANADA: 200828 NADA: 101479 NADA: 106616 NADA: 137409 NADA: 141299 NADA: 141312 NDC Package: 0061-0214-02 NDC Package: 0061-0851-03 NDC Package: 0061-0851-04 NDC Package: 0061-4305-01 NDC Package: 0061-4305-02

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200828 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200489 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

High: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (4) · Loss of appetite, Haemorrhagic diarrhoea, Diarrhea Neurologic (1) · Tiredness (lethargy) Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (ectoparasite) - tick NOS Other (25) · Surgical site disorder, Shaking, Reluctant to move

Most Reported Reactions

Body system	Cases	Species	Serious cases
Neurologic	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1
Other	1	Dog	1

Species coverage: Dog (25) Cat (7)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Neurologic	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Digestive	Cat	Serious	-	1
Other	Cat	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Digestive	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Digestive	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Digestive	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2019-US-025839

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)

No owner handouts linked yet.

Official label / PI (6)

A-200489-C-0073-NL-AA_PI_2.pdf · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/2340
N-137409-C-0125-NL-AA_PI.pdf · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/1998
A-200781-C-0017-NL-AA_PI.pdf · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/1938
A-200476-R-0049-CS-AA_PI.pdf · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/1539
101-479 · EA
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/114
101-479 · FONSI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/116

SPL (16)

nixiFLOR™ · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18227/nixiFLOR%E2%84%A2
Flunazine®-S · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2041/Flunazine%C2%AE-S
Flunine-S™ · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17066/Flunine-S%E2%84%A2
Banamine® Paste · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2484/Banamine%C2%AE%20Paste
Resflor GOLD® · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2193/Resflor%20GOLD%C2%AE
Flunine™ · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/15706/Flunine%E2%84%A2
Flunixin Injection - S · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2022/Flunixin%20Injection%20-%20S
Flu-Nix™ · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/252/Flu-Nix%E2%84%A2
Banamine® · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1920/Banamine%C2%AE
Banamine®-S · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1921/Banamine%C2%AE-S
Hexasol® Injection · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2198/Hexasol%C2%AE%20Injection
Flunazine® · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2299/Flunazine%C2%AE
Flunazine™ · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/183/Flunazine%E2%84%A2
Flunixin Meglumine Solution · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/305/Flunixin%20Meglumine%20Solution
Flunixin Meglumine Injection · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/310/Flunixin%20Meglumine%20Injection
Banamine® Granules · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1948/Banamine%C2%AE%20Granules

FOI (23)

FOI Summary oA 200-828 Approved January 9, 2026.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17866
UCM210561.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1195
FOI Summary oA 200-791 Approved April 3 2025_ceg_ef.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16765
UCM231147.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/864
UCM203309.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/863
FOI Summary oA 200-781 Approved May 16, 2024.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15467
UCM181537.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1185
UCM241575.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/964
ucm061576.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/963
A200061_Orig_09_11_1996.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2045
ucm064912.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/356
ucm064910.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/355
ucm064907.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/354
353.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1485
UCM243040.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/872
UCM421903.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1256
A200387_Supp_12_18_2008.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1922
ucm061339.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1136
A200142_Orig_09_25_1995.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1957
ucm061593.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/982
ucm061738.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/981
ucm061590.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/680
A200124_Org_9_25_1995.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1329

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17866 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18227/nixiFLOR%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1195 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/2340 · document · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2041/Flunazine%C2%AE-S · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16765 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17066/Flunine-S%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/1998 · document · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2484/Banamine%C2%AE%20Paste · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/864 · document · FOI

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness

Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:15 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

Official (FDA)

Identity: Generic ingredient • FDA branded products available

Official FDA brands: Banamine® Banamine®-S Banamine® Granules Banamine® Paste Flu-Nix™ Flunazine® Flunazine®-S Flunazine™ Flunine-S™ Flunine™ Flunixin Injection - S Flunixin Meglumine Injection Flunixin Meglumine Solution Hexasol® Injection Resflor GOLD® nixiFLOR™

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Beef, Beef And Dairy, Beef And Non-Lactating Dairy, Calves, Dairy, Horse, No Use Class Stated Or Implied, No use class stated or implied

Rx/OTC: RX

Form/route: Injectable Solution, Liquid (Solution), Paste, Top Dressing In Feed • Intramuscular, Intravenous, Oral, Subcutaneous

Applications: ANADA 200-828 • ANADA 200-489 • ANADA 200-791 • NADA 137-409 • NADA 141-299 • ANADA 200-781 • ANADA 200-476 • ANADA 200-061 • NADA 101-479 • NADA 141-312 • ANADA 200-581 • ANADA 200-387 • ANADA 200-142 • ANADA 200-124 • NADA 106-616

Documents: 29 (FOI: 23) • SPL: 16 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 8 • Cat 8 • View

Case summaries: 6 (showing 6) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Mastitis Pain (acute, chronic) Pneumonia (aspiration, bacterial, viral)

Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)

Top reaction signals

Tiredness (lethargy) (1) Surgical site disorder (1) Shaking (1) Reluctant to move (1) Proprioception deficit (1) Polydipsia (1) Peritonitis (1) Panting (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers

Package NDC	Product NDC	Status
0061-0214-02	0061	-
0061-0851-03	0061	-
0061-0851-04	0061	-
0061-4305-01	0061	-
0061-4305-02	0061	-
0061-4305-03	0061	-
0061-4363-01	0061	-
0061-4363-02	0061	-
0061-4363-03	0061	-
11695-7021-1	11695	-
11695-7021-2	11695	-
13985-018-02	13985	-
13985-018-04	13985	-
13985-707-15	13985	-
23243-0120-4	23243	-
23243-0120-5	23243	-
46066-008-02	46066	-
46066-008-04	46066	-
46066-102-03	46066	-
46066-102-04	46066	-

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

FOI Summary oA 200-828 Approved January 9, 2026.pdf • FOI summary • Official • Feb. 3, 2026
FDA FOI summary for application 200828
A-200489-C-0073-NL-AA_PI_2.pdf • Official label • Official • Dec. 16, 2025
FDA official labeling for application 200489
UCM210561.pdf • FOI summary • Official • Dec. 16, 2025
FDA FOI summary for application 200489
FOI Summary oA 200-791 Approved April 3 2025_ceg_ef.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 200791
N-137409-C-0125-NL-AA_PI.pdf • Official label • Official • Feb. 24, 2025
FDA official labeling for application 137409
UCM203309.pdf • FOI summary • Official • Aug. 6, 2024
FDA FOI summary for application 141299
UCM231147.pdf • FOI summary • Official • Aug. 6, 2024
FDA FOI summary for application 141299
A-200781-C-0017-NL-AA_PI.pdf • Official label • Official • July 16, 2024
FDA official labeling for application 200781
FOI Summary oA 200-781 Approved May 16, 2024.pdf • FOI summary • Official • July 16, 2024
FDA FOI summary for application 200781
A-200476-R-0049-CS-AA_PI.pdf • Official label • Official • Aug. 21, 2023
FDA official labeling for application 200476
UCM181537.pdf • FOI summary • Official • Aug. 21, 2023
FDA FOI summary for application 200476
A200061_Orig_09_11_1996.pdf • FOI summary • Official • June 1, 2022
FDA FOI summary for application 200061
ucm061576.pdf • FOI summary • Official • June 1, 2022
FDA FOI summary for application 200061
UCM241575.pdf • FOI summary • Official • June 1, 2022
FDA FOI summary for application 200061
353.pdf • FOI summary • Official • May 3, 2022
FDA FOI summary for application 101479
ucm064907.pdf • FOI summary • Official • May 3, 2022
FDA FOI summary for application 101479
ucm064910.pdf • FOI summary • Official • May 3, 2022
FDA FOI summary for application 101479
ucm064912.pdf • FOI summary • Official • May 3, 2022
FDA FOI summary for application 101479
UCM243040.pdf • FOI summary • Official • March 4, 2022
FDA FOI summary for application 141312
UCM421903.pdf • FOI summary • Official • Oct. 2, 2018
FDA FOI summary for application 200581
ucm061339.pdf • FOI summary • Official • Oct. 2, 2018
FDA FOI summary for application 200387
A200387_Supp_12_18_2008.pdf • FOI summary • Official • Oct. 2, 2018
FDA FOI summary for application 200387
A200142_Orig_09_25_1995.pdf • FOI summary • Official • July 28, 2017
FDA FOI summary for application 200142
A200124_Org_9_25_1995.pdf • FOI summary • Official • May 16, 2017
FDA FOI summary for application 200124
ucm061590.pdf • FOI summary • Official • May 16, 2017
FDA FOI summary for application 200124
ucm061738.pdf • FOI summary • Official • May 16, 2017
FDA FOI summary for application 200124
ucm061593.pdf • FOI summary • Official • May 16, 2017
FDA FOI summary for application 200124

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 30 Clinical 0 Manufacturer 0 Marketing 0

Current Field Facts

contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not slaughter for human consu… (Official, 2026-02-12)
side_effects: Top reported reactions (openFDA): Vomiting, Death, Diarrhoea, Elevated total bilirubin, Lack of efficacy - NOS, Lethargy (see also Central nervous system depre… (Official, 2026-02-12)
usage: For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. For control of pyre… (Official, 2026-02-12)

Recent Revisions

side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product	Sponsor	Application	Status	Published
nixiFLOR™ RX Florfenicol Flunixin Meglumine Injectable Solution • Subcutaneous Label highlights Official documents	Parnell Technologies Pty. Ltd.	ANADA 200-828	Approved	Feb 3, 2026
Flunazine®-S RX Flunixin Meglumine Injectable Solution • Intramuscular Label highlights Official documents	Bimeda Animal Health Limited	ANADA 200-489	Approved	Dec 16, 2025
Flunine-S™ RX Flunixin Meglumine Injectable Solution • Intramuscular Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-791	Approved	Jun 3, 2025
Banamine® Paste RX Flunixin Meglumine Paste • Oral Label highlights Official documents	Intervet, Inc.	NADA 137-409	Approved	Feb 24, 2025
Resflor GOLD® RX Florfenicol Flunixin Meglumine Injectable Solution • Subcutaneous Label highlights Official documents	Intervet, Inc.	NADA 141-299	Approved	Aug 6, 2024
Flunine™ RX Flunixin Meglumine Injectable Solution • Intramuscular, Intravenous Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-781	Approved	Jul 16, 2024
Flunixin Injection - S RX Flunixin Meglumine Liquid (Solution) • Intramuscular Label highlights Official documents	Norbrook Laboratories, Ltd.	ANADA 200-476	Approved	Aug 21, 2023
Flu-Nix™ RX Flunixin Meglumine Liquid (Solution) • Intramuscular, Intravenous Label highlights Official documents	Huvepharma EOOD	ANADA 200-061	Approved	Jun 1, 2022
Banamine® Banamine®-S RX Flunixin Meglumine Injectable Solution • Intravenous, Intramuscular Label highlights Official documents	Intervet, Inc.	NADA 101-479	Approved	May 3, 2022
Hexasol® Injection RX Flunixin Meglumine Oxytetracycline Liquid (Solution) • Intramuscular, Subcutaneous Label highlights Official documents	Norbrook Laboratories, Ltd.	NADA 141-312	Approved	Mar 4, 2022
Flunazine® RX Flunixin Meglumine Paste • Oral Label highlights Official documents	Bimeda Animal Health Limited	ANADA 200-581	Approved	Oct 2, 2018
Flunazine™ RX Flunixin Meglumine Liquid (Solution) • Intravenous, Intramuscular Label highlights Official documents	Bimeda Animal Health Limited	ANADA 200-387	Approved	Oct 2, 2018
Flunixin Meglumine Solution RX Flunixin Meglumine Liquid (Solution) • Intramuscular, Intravenous Label highlights Official documents	Zoetis Inc.	ANADA 200-142	Approved	Jul 28, 2017
Flunixin Meglumine Injection RX Flunixin Meglumine Liquid (Solution) • Intravenous, Intramuscular Label highlights Official documents	Elanco US Inc.	ANADA 200-124	Approved	May 16, 2017
Banamine® Granules RX Flunixin Meglumine Top Dressing In Feed • Oral Label highlights Official documents	Intervet, Inc.	NADA 106-616	Approved	Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Beef And Non-Lactating Dairy

Composition / specifications

300 mg florfenicol and 16.5 mg flunixin (as flunixin meglumine) per mL

Beef and non-lactating dairy cattle

Indication

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

Dosage

40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied

Composition / specifications

Each milliliter contains flunixin meglumine equivalent to 50 mg of flunixin.

Swine

Indication

For the control of pyrexia associated with swine respiratory disease.

Dosage

Administer 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight as a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

Limitations

For intramuscular use in swine. Not tor use in breeding swine.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications

50 mg flunixin (equivalent to 83 mg flunixin meglumine) per mL

Swine

Indication

For the control of pyrexia associated with swine respiratory disease

Dosage

2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production

Composition / specifications

Each 30-gram syringe contains flunixin meglumine equivalent to 1,500 milligrams of flunixin.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders.

Dosage

0.5 milligram of flunixin per pound of body weight daily.

Limitations

For oral use only. Treatment should not exceed 5 consecutive days. The effect of this drug on pregnancy has not been determined. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, non-lactating

Composition / specifications

300 mg florfenicol and 16.5 mg flunixin as flunixin meglumine

Cattle (Beef and Non-Lactating Dairy)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non lactating dairy cattle.

Dosage

Administer once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dairy, excluding dry cows • No Use Class Stated Or Implied

Composition / specifications

50 mg/mL

Horses

Indication

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

Dosage

The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Treatment may be repeated when signs of colic recur.

Limitations

Cattle

Indication

For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.

Dosage

The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia, is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied

Label highlights

Indication

For the control of pyrexia associated with swine respiratory disease.

Dosage

The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site

Limitations

Not for use in breeding swine. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production • Beef And Dairy

Composition / specifications

Each mL contains flunixin meglumine equivalent to 50 mg flunixin.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (Beef and dairy)

Indication

For control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.

Dosage

1.1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.

Limitations

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production • Beef, excluding breeding bulls • Dairy, excluding dry dairy cows and breeding bulls • Calves, excluding veal calves

Composition / specifications

The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle

Indication

For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia.

Dosage

1. 1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days (control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia).

2. 2mg/kg (1.0 mg/lb) of body weight given once by intravenous administration for control of pyrexia associated with acute bovine mastitis.

Limitations

Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, non-lactating

Composition / specifications

300 mg oxytetracycline and 20 mg flunixin base as flunixin meglumine per mL.

Cattle (Beef, Non-Lactating Dairy, Calves, Yearlings)

Indication

For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle

Dosage

Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For intramuscular or subcutaneous use in beef and non-lactating dairy cattle, calves and yearlings. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows, bulls intended for breeding, and calves intended to be processed for veal. Do not use in animals showing hypersensitivity to either flunixin meglumine or oxytetracycline.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied

Composition / specifications

30 grams of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.

Label highlights

Indication

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse

Dosage

0.5 mg per pound of body weight per day for up to 5 days

Limitations

For oral use in horses only. Treatment should not exceed 5 consecutive days. The effect of flunixin meglumine on pregnancy has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy • No Use Class Stated Or Implied

Composition / specifications

<span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL of solution contains flunixin meglumine equivalent to 50 mg flunixin.</span>

Cattle

Indication

For the control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis.

Dosage

1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) body weight given by slow intravenous administration, either once a day as a single dose, or divided into two doses at 12-hour intervals for up to 3 days; for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia. 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration for acute bovine mastitis.

Limitations

The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in calves to be processed for veal. Do not use in dry dairy cows.

Horses

Indication

For the alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production

Composition / specifications

The drug contains 50 milligrams of flunixin per milliliter of aqueous solution.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of pain associated with colic.

Dosage

0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days.

Limitations

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy • No Use Class Stated Or Implied

Composition / specifications

<pre><span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL of solution contains flunixin meglumine equivalent to 50 mg flunixin. </span></pre><p> 

Horses

Indication

For the alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.

Dosage

0.5 mg per pound of body weight once daily, intravenously or intramuscularly, for up to 5 days.

Limitations

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle

Indication

For control of pyrexia associated with acute bovine mastitis.

Dosage

2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lb) of body weight given once by intravenous administration.

Limitations

Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

For control of pyrexia associated with bovine respiratory disease and endotoxemia. Also indicated for the control of inflammation in endotoxemia.

Dosage

1.1 to 2.2 mg/kg (0.5 to 1.0 mg/lb; 1 to 2 mL per 100 lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.

Limitations

Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production

Composition / specifications

Each 10-gram packet contains flunixin meglumine equivalent to 250 milligrams of flunixin.

Horses

Indication

For alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

Dosage

0.5 milligram of flunixin per pound of body weight (one packet per 500 pounds) per day.

Limitations

Administer daily dose for up to 5 days by sprinkling on small amount of feed. The effect of this drug on pregnancy has not been determined. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents

FOI FOI Summary oA 200-828 Approved January 9, 2026.pdf

Summary

For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

SPL Packages

nixiFLOR™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM210561.pdf

Summary

For the control of pyrexia associated with swine respiratory disease.
Labeling A-200489-C-0073-NL-AA_PI_2.pdf

SPL Packages

Flunazine®-S (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI FOI Summary oA 200-791 Approved April 3 2025_ceg_ef.pdf

Summary

For the control of pyrexia associated with swine respiratory disease

SPL Packages

Flunine-S™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

Labeling N-137409-C-0125-NL-AA_PI.pdf

SPL Packages

Banamine® Paste (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM231147.pdf

Summary

This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the treatment of BRD and control of BRD-associated pyrexia indication.
FOI UCM203309.pdf

Summary

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

SPL Packages

Resflor GOLD® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI FOI Summary oA 200-781 Approved May 16, 2024.pdf

Summary

Horse: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
Cattle: For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.
Labeling A-200781-C-0017-NL-AA_PI.pdf

SPL Packages

Flunine™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM181537.pdf

Summary

For the control of pyrexia associated with swine respiratory disease.
Labeling A-200476-R-0049-CS-AA_PI.pdf

SPL Packages

Flunixin Injection - S (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM241575.pdf

Summary

This supplement provides for a change in proprietary name and the addition of the lactating dairy cattle indication, “For the control of pyrexia associated with acute bovine mastitis.”
FOI ucm061576.pdf

Summary

This supplement provides for the addition of a claim for intravenous use in beef cattle and nonlactating dairy cattle to the labeling of the approved product Flunixin Meglumine Solution. The exclusivity period protecting this claim for the pioneer product expired on May 6, 2001.
FOI A200061_Orig_09_11_1996.pdf

Summary

For the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.

SPL Packages

Flu-Nix™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm064912.pdf

Summary

This supplement allows for use in swine for the control of pyrexia associated with swine respiratory disease. This product has been approved for beef and lactating dairy cattle and horses.
FOI ucm064910.pdf

Summary

This supplement allows for use in lactating dairy cattle for the existing indications of “the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia.” Additionally, it allows for a new indication “for the control of pyrexia associated with acute bovine mastitis” and it establishes a tolerance for residues of flunixin in milk.
FOI ucm064907.pdf

Summary

This supplement provides for an additional statement added to the Precaution section of the labeling and a heading change on the label from Warning to Adverse Reactions to the previously approved product labeling for BANAMINE® Injectable Solution.
FOI 353.pdf

Summary

This supplement provides for the additional species, cattle, to be added to the previously approved product, BANAMINE® Injectable Solution.
EA 101-479
FONSI 101-479

SPL Packages

Banamine® (ZIP)
Banamine®-S (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM243040.pdf

Summary

For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle.

SPL Packages

Hexasol® Injection (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM421903.pdf

Summary

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

SPL Packages

Flunazine® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200387_Supp_12_18_2008.pdf

Summary

The supplement requests the addition of a new indication, "for the control of pyrexia associated with acute bovine mastitis", that is no longer protected by marketing exclusivity.
FOI ucm061339.pdf

Summary

Horse: recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
Cattle: indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia. Flunixin Meglumine Injection is also indicated for the control of inflammation in endotoxemia.

SPL Packages

Flunazine™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200142_Orig_09_25_1995.pdf

Summary

For the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.

SPL Packages

Flunixin Meglumine Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061593.pdf

Summary

The effect of this supplement is to allow for the addition of a new indication, “for the control of pyrexia associated with acute bovine mastitis”, that is no longer protected by marketing exclusivity.
FOI ucm061738.pdf

Summary

This supplement provides the addition of lactating dairy cattle to the existing claim allowing for the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia. The addition of lactating dairy cattle to the pioneer labeling was approved on August 19, 2004, and was not protected by exclusivity.
FOI ucm061590.pdf

Summary

The supplement provides revised labeling with the addition of a new species, cattle, to the previously approved generic product for horses only.
FOI A200124_Org_9_25_1995.pdf

Summary

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

SPL Packages

Flunixin Meglumine Injection (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Banamine® Granules (ZIP)

FDA page: Open in Animal Drugs @ FDA

Usage

For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic. For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for control of inflammation in endotoxemia. For the control of pyrexia associated with swine respiratory disease.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Loss of appetite (1) • Cat Haemorrhagic diarrhoea (1) • Dog Diarrhea (1) • Dog Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Neurologic

Tiredness (1) • Cat

Showing top 5 for Neurologic.

Effectiveness

Lack of efficacy - NOS (1) • Dog Lack of efficacy (ectoparasite) - tick NOS (1) • Cat

Showing top 5 for Effectiveness.

Other

Surgical site disorder (1) • Dog Shaking (1) • Dog Reluctant to move (1) • Cat Proprioception deficit (1) • Dog Polydipsia (1) • Dog

Show more (20)

Peritonitis (1) • Dog Panting (1) • Dog Other abnormal test result NOS (1) • Dog Not eating (1) • Dog Leucopenia NOS (1) • Cat Intestinal perforation (1) • Dog Hypothermia (1) • Dog Febrile (1) • Cat Elevated total bilirubin (1) • Dog Elevated liver enzymes (1) • Dog Elevated alanine aminotransferase (1) • Dog Ear infection NOS (1) • Dog Distension of abdomen (1) • Dog Dehydration (1) • Dog Decreased red blood cell count (1) • Dog Death (1) • Dog Claw / hoof / nail disorder NOS (1) • Dog Anaphylaxis (1) • Dog Adipsia (1) • Cat Abnormal radiograph finding (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Griffon - French Wire-haired Pointing, Female, 23 month, 15.4 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy - NOS, Other abnormal test result NOS, Elevated total bilirubin, Decreased red blood cell count, Ear infection NOS… • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2023-US-062807
Serious AE: No
Treated For AE: Yes
Sex: Female
Age: 23.00 Month
Weight: 15.400 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown

Reactions Reported:

Lack of efficacy - NOS Other abnormal test result NOS Elevated total bilirubin Decreased red blood cell count Ear infection NOS Vomiting

Outcomes: Outcome Unknown

Dog, ['Retriever - Labrador', 'Dog (unknown)'], Female, 3 year, 18.824 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Vomiting, Weakness, Diarrhea, Haemorrhagic diarrhoea, Anaphylaxis… • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2023-US-009609
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 3.00 Year
Weight: 18.824 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Injection, solution

Reactions Reported:

Vomiting Weakness Diarrhea Haemorrhagic diarrhoea Anaphylaxis Elevated liver enzymes Elevated total bilirubin

Outcomes: Recovered/Normal

Cat, Siamese, Male, 7 year, 6.804 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Tiredness (lethargy), Third eyelid protrusion, Loss of appetite, Adipsia, Lack of efficacy (ectoparasite) - tick NOS… • Outcome: Ongoing

Report ID: USA-USFDACVM-2020-US-020224
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 7.00 Year
Weight: 6.804 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Tiredness (lethargy) Third eyelid protrusion Loss of appetite Adipsia Lack of efficacy (ectoparasite) - tick NOS Vomiting Reluctant to move Febrile Leucopenia NOS

Outcomes: Ongoing

Dog, Ridgeback - Rhodesian, Male, 6 year, 32.749 kilogram • Drug: MSK, Liquid, Unknown • Reactions: Shaking, Panting, Tiredness (lethargy), Proprioception deficit, Dehydration… • Outcome: Died

Report ID: USA-USFDACVM-2019-US-026054
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 6.00 Year
Weight: 32.749 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Liquid

Reactions Reported:

Shaking Panting Tiredness (lethargy) Proprioception deficit Dehydration Elevated alanine aminotransferase Vomiting Polydipsia Bloody diarrhoea Hypothermia Death

Outcomes: Died

Dog, Retriever - Labrador, Female, 2 year, 34.927 kilogram • Drug: MSK, Intramuscular, Dose: 0.70 mL per unknown, Frequency: 5 per month • Reactions: Not eating, Tiredness (lethargy), Vomiting, Surgical site disorder, Distension of abdomen… • Outcome: Died

Report ID: USA-USFDACVM-2019-US-025839
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 2.00 Year
Weight: 34.927 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Intramuscular
Dose: 0.70 mL per unknown
Frequency: 5 per month

Reactions Reported:

Not eating Tiredness (lethargy) Vomiting Surgical site disorder Distension of abdomen Abnormal radiograph finding Intestinal perforation Peritonitis Death

Outcomes: Died

Dog, Spaniel - Springer English, Male, 2 year • Drug: MSK, Intravenous, Dose: 4 Milligram per unknown • Reactions: Lack of efficacy - NOS, Claw / hoof / nail disorder NOS • Outcome: Ongoing

Report ID: USA-USFDACVM-2018-US-021211
Serious AE: No
Treated For AE: No
Sex: Male
Age: 2.00 Year

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Intravenous
Dose: 4 Milligram per unknown

Reactions Reported:

Lack of efficacy - NOS Claw / hoof / nail disorder NOS

Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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