FDA Adverse Events Reports (FAERS) Summary for PONSTEL

These tables and charts are based on 241 total reports for PONSTEL (MEFENAMIC ACID) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 238 pharmaceutical company-submitted and non-U.S. FAERS reports and 3 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 3 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch PONSTEL summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with PONSTEL (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	VOMITING	16
2	PAIN	15
3	ANXIETY	14
4	INJURY	14
5	DIARRHEA	12
6	ANEMIA	11
7	NAUSEA	11
8	SWELLING OF LIMBS	11
9	PULMONARY EMBOLISM	11
10	ABDOMINAL PAIN	10
11	INSOMNIA	10
12	RASH	10
13	CHOLECYSTITIS CHRONIC	9
14	GALLSTONES	9
15	DRUG HYPERSENSITIVITY	9
16	SHORTNESS OF BREATH	9
17	GASTROINTESTINAL BLEEDING	9
18	HEADACHE	9
19	FEVER	9
20	STOMATITIS	9
21	ABDOMINAL PAIN UPPER	8
22	EMOTIONAL DISTRESS	8
23	GALLBLADDER DISORDER	8
24	GASTRIC ULCER	8
25	PAIN IN EXTREMITY	8
26	CHOLECYSTITIS	7
27	CONSTIPATION	7
28	DIZZINESS	7
29	DRUG INEFFECTIVE	7
30	INTENTIONAL OVERDOSE	7
31	OVERDOSE	7
32	SUICIDE ATTEMPT	7
33	DIFFICULTY SWALLOWING	6
34	FATIGUE	6
35	HEART RATE INCREASED	6
36	PNEUMONIA	6
37	KIDNEY IMPAIRMENT	6
38	ACUTE KIDNEY INJURY	5
39	ALT LIVER ENZYME INCREASED	5
40	LACK OF STRENGTH AND ENERGY (ASTHENIA)	5
41	CHEST PAIN	5
42	COMA	5
43	CONVULSION	5
44	DEEP VEIN THROMBOSIS	5
45	DEPRESSION	5
46	DRUG ERUPTION	5
47	DRUG INTERACTION	5
48	ENCEPHALOPATHY	5
49	VOMITING BLOOD	5
50	HIGH BLOOD PRESSURE	5
51	LOW BLOOD PRESSURE	5
52	HYPOXIA	5
53	LOSS OF CONSCIOUSNESS	5
54	THROAT PAIN	5
55	PANIC ATTACK	5
56	PROCEDURAL PAIN	5
57	ITCHING	5
58	RENAL FAILURE ACUTE	5
59	HIVES	5
60	ABDOMINAL DISTENSION	4
61	ABDOMINAL PAIN LOWER	4
62	AMNESIA	4
63	ASPARTATE AMINOTRANSFERASE INCREASED	4
64	BACK PAIN	4
65	BILIARY DYSKINESIA	4
66	BLOOD PRESSURE DECREASED	4
67	CHEST DISCOMFORT	4
68	CHOLECYSTECTOMY	4
69	ENDOCARDITIS	4
70	SKIN REDNESS	4
71	GASTRITIS HAEMORRHAGIC	4
72	GENERAL PHYSICAL HEALTH DETERIORATION	4
73	HAEMODIALYSIS	4
74	LIVER FUNCTION ABNORMAL	4
75	MUSCLE SPASMS	4
76	MUSCLE TWITCHING	4
77	PALPITATIONS	4
78	PELVIC PAIN	4
79	SORE THROAT	4
80	PULSE ABNORMAL	4
81	RHABDOMYOLYSIS	4
82	SEROTONIN SYNDROME	4
83	DROWSINESS	4
84	THROMBOCYTOPENIA	4
85	ABSCESS	3
86	ACNE	3
87	LOSS OF ALL PLEASURE	3
88	JOINT PAIN	3
89	ARTHRITIS INFECTIVE	3
90	BLOOD UREA INCREASED	3
91	HEART RATE LOW (BRADYCARDIA)	3
92	CARDIO-RESPIRATORY ARREST	3
93	CONDITION AGGRAVATED	3
94	COUGH	3
95	BLUE LIPS	3
96	DEVICE DISLOCATION	3
97	DRUG ABUSE	3
98	DRUG WITHDRAWAL SYNDROME	3
99	FEELING ABNORMAL	3
100	GASTROENTERITIS	3

Latest Known Outcomes for Reactions Reported for PONSTEL

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Patient recovered	55
2	Unknown Outcome	54
3	Patient is recovering/symptoms resolving	35
4	Patient has not recovered/symtoms have not resolved	28
5	Patient died	15
6	Patient has recovered but has consequent health issues	2

Search all MedWatch and FAERS by keyword:

PONSTEL Total Reports

Male	Female	Unknown	Total
76	157	8	241

Top Countries Reporting

	Country	Number of Reports
1	Japan	66
2	United States	51
3	India	4
4	South Korea	4
5	Switzerland	2
6	Germany	2
7	Turkey	1

Outcomes for Reports

Serious: 215
Not Serious: 26
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Top Companies Reporting

Safety-Related FDA Updates

PONSTEL (MEFENAMIC ACID) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with PONSTEL? Rate PONSTEL at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for PONSTEL reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.