Drug Safety Information for PROBENECID (Probenecid)

Adverse Drug Reactions for PROBENECID* (Probenecid)

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 PROBENECID
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea36
2Diarrhoea33
3Pneumonia32
4Renal failure31
5Nausea31
6Asthenia29
7Headache28
8Renal failure acute27
9Dizziness25
10Oedema peripheral24
11Pain24
12Drug ineffective23
13Blood creatinine increased22
14Flushing22
15Anaemia21
16Arthralgia21
17Vomiting21
18Fatigue21
19Pyrexia19
20Gout19

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

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

Reason # of FDA Reports
1Gout*358
2Product used for unknown indication207
3Hyperuricaemia68
4Drug toxicity prophylaxis29
5Familial mediterranean fever18
6Gouty arthritis18
7Renal impairment15
8Prophylaxis14
9Synovitis11
10Syphilis11

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


Types of Adverse Events for PROBENECID

Total Reports Filed with FDA: 3517


Number of FDA Adverse Event Reports by Patient Age for PROBENECID

Total Reports Filed with FDA: 3517*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Probenecid (Probecid, Probenecid, Benecid, Probalan, Benemid)

Charts are based on 3517 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 PROBENECID 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.