Drug Safety Information for DOLOBID (Diflunisal)

Adverse Drug Reactions for DOLOBID* (Diflunisal)

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 DOLOBID
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	32
2	Headache	27
3	Completed suicide	24
4	Diarrhoea	24
5	Fatigue	19
6	Pain	19
7	Fall	18
8	Arthralgia	18
9	Pneumonia	17
10	Dizziness	17
11	Drug ineffective	16
12	Malaise	16
13	Insomnia	16
14	Anaemia	16
15	Anxiety	15
16	Pain in extremity	15
17	Vomiting	15
18	Depression	14
19	Chest pain	14
20	Injection site pain	13

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	167
2	Rheumatoid arthritis*	134
3	Arthritis	74
4	Pain	51
5	Hypertension	34
6	Fibromyalgia	31
7	Antiinflammatory therapy	27
8	Psoriatic arthropathy*	18
9	Arthralgia	14
10	Chest pain	11

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

Types of Adverse Events for DOLOBID

Total Reports Filed with FDA: 2418

Number of FDA Adverse Event Reports by Patient Age for DOLOBID

Total Reports Filed with FDA: 2418*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diflunisal (Diflunisal, Dolobid)

Charts are based on 2418 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.