FDA Adverse Events Reports (FAERS) Summary for DUEXIS

These tables and charts are based on 1,492 total reports for DUEXIS (FAMOTIDINE\IBUPROFEN) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 1,433 pharmaceutical company-submitted and non-U.S. FAERS reports and 59 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 59 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch DUEXIS summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	OFF LABEL USE	345
2	DRUG INEFFECTIVE	112
3	PAIN	107
4	ABDOMINAL DISCOMFORT	79
5	CHRONIC KIDNEY DISEASE	73
6	NAUSEA	73
7	HEADACHE	70
8	ABDOMINAL PAIN UPPER	60
9	DIARRHEA	59
10	THERAPY CESSATION	55
11	INTENTIONAL PRODUCT USE ISSUE	53
12	JOINT PAIN	52
13	KIDNEY FAILURE	48
14	ACUTE KIDNEY INJURY	46
15	FATIGUE	43
16	RASH	41
17	DIZZINESS	40
18	VOMITING	35
19	INSOMNIA	33
20	FALL	31
21	ITCHING	30
22	PAIN IN EXTREMITY	29
23	HIGH BLOOD PRESSURE	28
24	BACK PAIN	27
25	INDIGESTION	27
26	PRODUCT DOSE OMISSION ISSUE	27
27	SHORTNESS OF BREATH	26
28	DEPRESSION	25
29	INSURANCE ISSUE	25
30	CHEST PAIN	24
31	HYPERSENSITIVITY	24
32	INTENTIONAL PRODUCT MISUSE	24
33	GASTROOESOPHAGEAL REFLUX DISEASE	23
34	JOINT SWELLING	23
35	HIVES	23
36	LOWER LIMBS SWELLING	22
37	WEIGHT INCREASED	22
38	CONDITION AGGRAVATED	21
39	FEELING ABNORMAL	21
40	DRUG DOSE OMISSION	20
41	INABILITY TO AFFORD MEDICATION	20
42	MALAISE	19
43	COUGH	18
44	ANXIETY	17
45	GASTROINTESTINAL BLEEDING	17
46	NUMBNESS	17
47	INJECTION SITE PAIN	17
48	ABDOMINAL DISTENSION	16
49	GAIT DISTURBANCE	16
50	BLOOD PRESSURE INCREASED	15
51	COVID-19	15
52	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	15
53	KIDNEY FAILURE	15
54	INCORRECT DOSE ADMINISTERED	15
55	DROWSINESS	15
56	HAIR LOSS	14
57	MEMORY IMPAIRMENT	14
58	MIGRAINE	14
59	MUSCLE SPASMS	14
60	PRODUCT SUPPLY ISSUE	14
61	FACIAL SWELLING	14
62	TREMOR	14
63	ABDOMINAL PAIN	13
64	CONSTIPATION	13
65	DRUG HYPERSENSITIVITY	13
66	RHEUMATOID ARTHRITIS	13
67	WEIGHT DECREASED	13
68	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	13
69	ARTHRITIS	12
70	LACK OF STRENGTH AND ENERGY (ASTHENIA)	12
71	CHEST DISCOMFORT	12
72	COMMON COLD	12
73	PRODUCT USE ISSUE	12
74	KIDNEY IMPAIRMENT	12
75	SWELLING	12
76	VISION BLURRED	12
77	BRUISE	11
78	SKIN REDNESS	11
79	BLOOD IN STOOL	11
80	PALPITATIONS	11
81	PRODUCT USE IN UNAPPROVED INDICATION	11
82	SINUSITIS	11
83	STRESS	11
84	URINARY TRACT INFECTION	11
85	VISUAL IMPAIRMENT	11
86	DEATH	10
87	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	10
88	PNEUMONIA	10
89	FEVER	10
90	ASTHMA	9
91	DRUG INTERACTION	9
92	EXPIRED PRODUCT ADMINISTERED	9
93	FEELING HOT	9
94	GASTROINTESTINAL DISORDER	9
95	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	9
96	INFLUENZA	9
97	INTERVERTEBRAL DISC PROTRUSION	9
98	MUSCLE PAIN	9
99	KIIDNEY INJURY	9
100	SPINAL OPERATION	9

Latest Known Outcomes for Reactions Reported for DUEXIS

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1053
2	Patient has not recovered/symtoms have not resolved	378
3	Patient recovered	314
4	Patient is recovering/symptoms resolving	97
5	Patient died	16
6	Patient has recovered but has consequent health issues	1

Search all MedWatch and FAERS by keyword:

DUEXIS Total Reports

Male	Female	Unknown	Total
394	979	119	1,492

Top Countries Reporting

	Country	Number of Reports
1	United States	1477
2	Mexico	1

Outcomes for Reports

Serious: 465
Not Serious: 1026
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

FDA Approval Date: 2011-04-23

DUEXIS (FAMOTIDINE; IBUPROFEN) Rx Drug:
Safety-related Labeling Changes

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