Drug Safety Information for ANSAID (Flurbiprofen)

Safety-related Labeling Changes for ANSAID (FLURBIPROFEN) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for ANSAID* (Flurbiprofen)

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 ANSAID
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia63
2Nausea44
3Vomiting43
4Pain35
5Renal failure acute34
6Dyspnoea32
7Diarrhoea30
8Pneumonia29
9Drug ineffective27
10Aspartate aminotransferase increased27
11Asthenia27
12Anaemia27
13Neoplasm malignant26
14Headache26
15Alanine aminotransferase increased25
16Malaise25
17Decreased appetite25
18Rash24
19Arthralgia23
20Hepatic function abnormal22

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

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

Reason # of FDA Reports
1Product used for unknown indication514
2Rheumatoid arthritis241
3Analgesic therapy118
4Pain100
5Cancer pain98
6Arthritis67
7Arthralgia55
8Hypophagia47
9Pyrexia37
10Endometriosis34

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


Types of Adverse Events for ANSAID

Total Reports Filed with FDA: 4231


Number of FDA Adverse Event Reports by Patient Age for ANSAID

Total Reports Filed with FDA: 4231*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Flurbiprofen (Flugalin, Ansaid, Strefen, Froben, Cebutid, Apo-flurbiprofen, Flurbiprofen)

Charts are based on 4231 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.

Click to go back to search results and ANSAID Reviews and Review Summary .

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.