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mefenamic acid Side Effects

Also known as: Ponstel

Analysis of 2,104 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

2,104

Death-Related

81

3.8% of reports

Hospitalizations

707

33.6% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
352
NAUSEA
296
FATIGUE
253
HEADACHE
227
PAIN
202
DIZZINESS
177
MALAISE
170
ARTHRALGIA
152
PAIN IN EXTREMITY
139
VOMITING
133
STRESS
130
DIARRHOEA
129
DRUG INTOLERANCE
127
DYSPNOEA
121
RHEUMATOID ARTHRITIS
120
OFF LABEL USE
118
PERIPHERAL SWELLING
110
PYREXIA
108
MUSCULOSKELETAL STIFFNESS
94
URTICARIA
93

Who Reports Side Effects

Gender Distribution

Female 1,507 (78%)
Male 427 (22%)
Unknown 5

Age Distribution

0-17 133 (9%)
18-44 668 (43%)
45-64 538 (35%)
65-74 112 (7%)
75+ 88 (6%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 81 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
CONDITION AGGRAVATED 8
DEATH 8
DECREASED APPETITE 8
DIZZINESS 8
ARTHRALGIA 7
DIARRHOEA 7
OVERDOSE 7
SEPTIC SHOCK 7
ABDOMINAL PAIN UPPER 6
ADJUSTMENT DISORDER WITH DEPRESSED MOOD 6
ALOPECIA 6
ANXIETY 6
BREAST CANCER STAGE III 6
BURSITIS 6
COLITIS ULCERATIVE 6
CONFUSIONAL STATE 6
CONTUSION 6
CROHN^S DISEASE 6
DELIRIUM 6
DISLOCATION OF VERTEBRA 6

Reactions in Hospitalization Reports

Top reactions in 707 reports where hospitalization was an outcome.

Reaction Reports
VOMITING 80
NAUSEA 60
DIZZINESS 51
HEADACHE 51
DIARRHOEA 47
DRUG INTERACTION 46
DRUG INEFFECTIVE 42
PYREXIA 40
RENAL FAILURE ACUTE 37
DYSPNOEA 35
OFF LABEL USE 35
TOXICITY TO VARIOUS AGENTS 34
MALAISE 33
ACUTE KIDNEY INJURY 30
ABDOMINAL DISCOMFORT 29
ABDOMINAL PAIN 29
CHILLS 29
HYPOTENSION 29
PAIN 28
ABDOMINAL PAIN UPPER 27

Nearby — Related Medications

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What the FAERS Data Reveals About mefenamic acid Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,104 voluntary reports linked to mefenamic acid and its brand equivalents (Ponstel), spanning 2004 through 2025. Of those, 81 (3.8%) listed death as an outcome and 707 (33.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 78% were female and 22% male; age distribution skews toward 18-44, with 668 reports in that bracket. The single most reported reaction is drug ineffective with 352 submissions, followed by nausea and fatigue.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.