Drug Safety Information for DUEXIS (Famotidine; ibuprofen)

FDA Safety-related Labeling Changes for DUEXIS (FAMOTIDINE; IBUPROFEN) Rx Drug: Safety Information Link

Adverse Drug Reactions for DUEXIS* (Famotidine; ibuprofen)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with DUEXIS
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	14
2	Headache	13
3	Drug ineffective	12
4	Diarrhoea	11
5	Dizziness	8
6	Off label use	7
7	Joint swelling	7
8	Injection site pain	6
9	Gastrointestinal haemorrhage	6
10	Abdominal pain	6
11	Dyspnoea	6
12	Palpitations	6
13	Chest pain	5
14	Tremor	5
15	Fatigue	5
16	Hypersensitivity	5
17	Abdominal pain upper	5
18	Muscle spasms	5
19	Somnolence	4
20	Inappropriate schedule of drug administration	4

* This side effect also appears in "Top 10 Side Effects of DUEXIS " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking DUEXIS
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Pain	55
2	Product used for unknown indication	48
3	Arthritis	24
4	Arthralgia	22
5	Osteoarthritis	22
6	Back pain	20
7	Psoriatic arthropathy	9
8	Rotator cuff syndrome	8
9	Gastrooesophageal reflux disease	8
10	Musculoskeletal stiffness	7

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for DUEXIS

Total Reports Filed with FDA: 425

Number of FDA Adverse Event Reports by Patient Age for DUEXIS

Total Reports Filed with FDA: 425*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Famotidine; ibuprofen (Duexis)

Charts are based on 425 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.