FDA Adverse Events Reports (FAERS) Summary for ANAPROX

These tables and charts are based on 740 total reports for ANAPROX (NAPROXEN SODIUM) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 726 pharmaceutical company-submitted and non-U.S. FAERS reports and 14 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 14 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ANAPROX summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	NAUSEA	86
2	PAIN	66
3	DRUG HYPERSENSITIVITY	65
4	DRUG INEFFECTIVE	62
5	HEADACHE	57
6	ANXIETY	56
7	SHORTNESS OF BREATH	49
8	FATIGUE	44
9	OFF LABEL USE	41
10	ABDOMINAL PAIN	39
11	DEPRESSION	39
12	DIARRHEA	39
13	DIZZINESS	39
14	PAIN IN EXTREMITY	39
15	JOINT PAIN	38
16	VOMITING	37
17	PULMONARY EMBOLISM	36
18	BACK PAIN	34
19	CHEST PAIN	34
20	DEEP VEIN THROMBOSIS	31
21	INJURY	31
22	LACK OF STRENGTH AND ENERGY (ASTHENIA)	27
23	FALL	26
24	INSOMNIA	26
25	MALAISE	26
26	COUGH	25
27	EMOTIONAL DISTRESS	25
28	ABDOMINAL DISCOMFORT	24
29	MIGRAINE	24
30	MUSCLE SPASMS	24
31	FEVER	23
32	GASTROOESOPHAGEAL REFLUX DISEASE	22
33	HIGH BLOOD PRESSURE	22
34	NUMBNESS	21
35	RASH	20
36	ABDOMINAL PAIN UPPER	19
37	CHOLECYSTITIS CHRONIC	19
38	CONDITION AGGRAVATED	18
39	DROWSINESS	18
40	WEIGHT DECREASED	18
41	ANEMIA	17
42	BRONCHITIS	17
43	HIVES	17
44	BLOOD PRESSURE INCREASED	16
45	CHRONIC KIDNEY DISEASE	15
46	DECREASED APPETITE	15
47	INDIGESTION	15
48	PNEUMONIA	15
49	ITCHING	15
50	AMNESIA	14
51	GALLSTONES	14
52	CONSTIPATION	14
53	GAIT DISTURBANCE	14
54	EXCESS SWEATING	14
55	COMMON COLD	14
56	ASTHMA	13
57	GALLBLADDER DISORDER	13
58	INJECTION SITE PAIN	13
59	MEMORY IMPAIRMENT	13
60	SWELLING OF LIMBS	13
61	PINS AND NEEDLES	13
62	PRODUCT USE IN UNAPPROVED INDICATION	13
63	URINARY TRACT INFECTION	13
64	JOINT PAIN	12
65	HYPERSENSITIVITY	12
66	INTERVERTEBRAL DISC PROTRUSION	12
67	OVERDOSE	12
68	KIDNEY FAILURE	12
69	SINUSITIS	12
70	WEIGHT INCREASED	12
71	ABDOMINAL DISTENSION	11
72	HAIR LOSS	11
73	ANAPHYLACTIC REACTION	11
74	ARTHRITIS	11
75	CHEST DISCOMFORT	11
76	GENERAL PHYSICAL HEALTH DETERIORATION	11
77	LOW BLOOD PRESSURE	11
78	INFLUENZA	11
79	LOSS OF CONSCIOUSNESS	11
80	MUSCULAR WEAKNESS	11
81	MUSCULOSKELETAL PAIN	11
82	MUSCLE PAIN	11
83	KIDNEY STONES	11
84	OSTEOARTHRITIS	11
85	PALPITATIONS	11
86	SUICIDAL IDEATION	11
87	TREMOR	11
88	VISION BLURRED	11
89	ABDOMINAL PAIN LOWER	10
90	COLITIS ULCERATIVE	10
91	SKIN REDNESS	10
92	HAEMOGLOBIN DECREASED	10
93	MUSCULOSKELETAL STIFFNESS	10
94	HEART ATTACK (MYOCARDIAL INFARCTION)	10
95	PELVIC PAIN	10
96	LOWER LIMBS SWELLING	10
97	TYPE 2 DIABETES MELLITUS	10
98	UTERINE PERFORATION	10
99	LOSS OF ALL PLEASURE	9
100	STROKE	9

Latest Known Outcomes for Reactions Reported for ANAPROX

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	308
2	Patient recovered	161
3	Patient has not recovered/symtoms have not resolved	146
4	Patient is recovering/symptoms resolving	66
5	Patient died	31
6	Patient has recovered but has consequent health issues	3

Search all MedWatch and FAERS by keyword:

ANAPROX Total Reports

Male	Female	Unknown	Total
154	514	72	740

Top Countries Reporting

	Country	Number of Reports
1	United States	362
2	Canada	87
3	South Korea	22
4	Puerto Rico	22
5	EU	8
6	Mexico	7
7	France	5
8	Colombia	2
9	Japan	2
10	Australia	1

Outcomes for Reports

Serious: 506
Not Serious: 234
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

Product used for unknown indication

Top Companies Reporting

Atnahs Healthcare

Safety-Related FDA Updates

FDA Approval Date: 1987-09-30

ANAPROX (NAPROXEN SODIUM) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with ANAPROX? Rate ANAPROX 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 ANAPROX 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.