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MEFENAMIC ACID
At a glance
| Generic name | MEFENAMIC ACID |
|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1967 |
Approved indications
Boxed warnings
- WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (see Warnings ). Mefenamic acid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see Contraindications , Warnings ). Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see Warnings ).
Common side effects
- Abdominal pain
- Nausea
- Diarrhea
- Dyspepsia
- Heartburn
- Vomiting
- Constipation
- Flatulence
- Headache
- Dizziness
- Rashes
- Pruritus
Serious adverse events
- Stevens-Johnson syndrome
- Toxic epidermal necrosis
- Anaphylactoid reactions
- Myocardial infarction
- Liver failure
- Renal failure
- Aplastic anemia
- Agranulocytosis
- Pancreatitis
- Congestive heart failure
Key clinical trials
- Vitamin E Plus Mefenamic Acid Versus Mefenamic Acid Alone for Treating Primary Dysmenorrhea in Women (PHASE4)
- Management of Abnormal Uterine Bleeding (NA)
- A Trial Investigating Lu AF28996 in Healthy Adult Participants (PHASE1)
- Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery (NA)
- Studies of Sulfur Metabolism in Humans (EARLY_PHASE1)
- A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults (PHASE1)
- Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate (PHASE1)
- Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MEFENAMIC ACID CI brief — competitive landscape report
- MEFENAMIC ACID updates RSS · CI watch RSS