Prescription medicine
Mefenamic acid First approved as Ponstel
Mefenamic acid (Ponstel) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.948 per mefenamic acid 250 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the mefenamic acid FDA label on DailyMed (effective April 20, 2026, Lupin Pharmaceuticals, Inc.); the NDA 15034 record on Drugs@FDA; every mefenamic acid label on DailyMed.
Highlights of the record
FDA label of April 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 and Precautions ( 5.1 )]. Mefenamic acid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications ( 4 ), see Warnings and Precautions ( 5.1 )]. 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 and Precautions ( 5.2 )]. WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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. […]
Used for
From the label: indications and usageMefenamic acid capsules are nonsteroidal anti-inflammatory drug indicated for: For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days).
Forms and strengths
- 250 mg
Capsule.
On the market
- Earliest approval on file
- March 28, 1967 Ponstel, Avion Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first November 19, 2010; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.948 per capsule Mefenamic acid 250 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2017 0 Class I among all firms' recalls; latest May 24, 2017
- FAERS reports
- 2,183 through July 30, 2026
What is mefenamic acid used for?
From the label: indications and usageMefenamic acid capsules are nonsteroidal anti-inflammatory drug indicated for: For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1 ) For treatment of primary dysmenorrhea. ( 1.2 ) 1.1 Mild to Moderate Pain Mefenamic acid capsules are indicated for management of mild to moderate pain in adults and pediatric patients 14 years of age and older, when therapy will not exceed one week (7 days). 1.2 Dysmenorrhea Mefenamic acid capsules are indicated for treatment of primary dysmenorrhea.
Conditions named in the indications of mefenamic acid's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Mefenamic Acid), Lupin Pharmaceuticals, Inc., effective April 20, 2026 (SPL set d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f), via openFDA; the full label on DailyMed
Is there a generic for mefenamic acid (Ponstel)?
The FDA approved the first generic mefenamic acid on November 19, 2010. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mefenamic acid from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1967 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mefenamic acid (Ponstel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.948 per Mefenamic acid 250 mg capsule, down 8% from $1.04 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Mefenamic acid 250 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mefenamic acid 250 mg capsule | Generic | $0.948 per capsule | $28.44 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has mefenamic acid been recalled?
The FDA's Enforcement Report lists 2 recalls naming mefenamic acid since 2017: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 24, 2017 | Class III | Shionogi Inc. | Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on … |
| May 24, 2017 | Class III | Shionogi Inc. | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mefenamic acid label say about other medicines?
The mefenamic acid label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name mefenamic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of mefenamic acid and cyclosporine may increase cyclosporine's nephrotoxicity. Intervention: During concomitant use of mefenamic acid and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of mefenamic acid with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy. Intervention: The concomitant use of mefenamic acid with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of mefenamic acid with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of mefenamic acid and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of mefenamic acid with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings … |
| Indomethacin | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis [See Clinical Pharmacology ( 12.3 )]. Intervention: During concomitant use of mefenamic acid and lithium, monitor patients for signs of lithium toxicity. |
| Magnesium hydroxide | drug interactions | Antacid Clinical Impact: Concomitant ingestion of antacids containing magnesium hydroxide has been shown to significantly increase the rate and extent of mefenamic acid absorption [See Clinical Pharmacology ()] Intervention: Concomitant use of mefenamic acid and antacids is not generally recommended because of possible increased adverse events. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of mefenamic acid and pemetrexed may increase the risk of pemetrexed- associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of mefenamic acid and methotrexate, monitor patients for methotrexate toxicity. |
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of mefenamic acid and pemetrexed may increase the risk of pemetrexed- associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of mefenamic acid and pemetrexed may increase the risk of pemetrexed- associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of mefenamic acid and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: During concomitant use of mefenamic acid and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
Every other medicine the mefenamic acid label names
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Drugs That Interfere with Hemostasis Clinical Impact: Mefenamic acid and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of mefenamic acid and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of mefenamic acid with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin … |
Source: FDA drug label (Mefenamic Acid), Lupin Pharmaceuticals, Inc., effective April 20, 2026 (SPL set d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f), via openFDA; the full label on DailyMed
What do FAERS reports show for mefenamic acid?
The FDA Adverse Event Reporting System holds 2,183 reports that list mefenamic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 107 are coded as a death and 747 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mefenamic acid?
43 other medicines are given the same way (oral) and in the same FDA class as mefenamic acid or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Acetaminophen and ibuprofen | Pain | 51 labelers | $0.107 per unit 250-125 mg | No current entry |
Every medicine labeled for the same conditions as mefenamic acid
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to mefenamic acid
- 43 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Mefenamic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other