Drug Safety Information for TRIMETHOPRIM (Trimethoprim)

Adverse Drug Reactions for TRIMETHOPRIM* (Trimethoprim)

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 TRIMETHOPRIM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia*378
2Nausea*359
3Drug interaction299
4Vomiting298
5Diarrhoea268
6Dyspnoea241
7Malaise*229
8Urinary tract infection221
9Renal failure acute215
10Headache*212
11Sepsis202
12Rash*187
13Asthenia185
14Fatigue177
15Pain175
16Confusional state168
17Neutropenia155
18Hypotension154
19Dizziness*154
20Pneumonia150

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

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

Reason # of FDA Reports
1Urinary tract infection*3503
2Product used for unknown indication3329
3Prophylaxis1247
4Antifungal prophylaxis1002
5Infection prophylaxis675
6Bladder pain594
7Antibiotic prophylaxis334
8Pneumocystis jiroveci pneumonia237
9Infection209
10Cystitis209

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


Types of Adverse Events for TRIMETHOPRIM

Total Reports Filed with FDA: 27870


Number of FDA Adverse Event Reports by Patient Age for TRIMETHOPRIM

Total Reports Filed with FDA: 27870*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Trimethoprim (Trimpex 200, Cotrim ds, Septrin forte, Septrin, Comox, Trimpex, Trimethoprim, Proloprim)

Charts are based on 27870 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 TRIMETHOPRIM 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.