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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

SULFAMETHOXAZOLE\TRIMETHOPRIM: 38,828 Adverse Event Reports & Safety Profile

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38,828
Total FAERS Reports
5,777 (14.9%)
Deaths Reported
19,426
Hospitalizations
38,828
As Primary/Secondary Suspect
5,012
Life-Threatening
3,094
Disabilities

First Report: 1969 · Latest Report: 20250922

What Are the Most Common SULFAMETHOXAZOLE\TRIMETHOPRIM Side Effects?

#1 Most Reported
Drug ineffective
4,868 reports (12.5%)
#2 Most Reported
Rash
4,649 reports (12.0%)
#3 Most Reported
Pyrexia
4,364 reports (11.2%)

All SULFAMETHOXAZOLE\TRIMETHOPRIM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 4,868 12.5% 1,217 2,134
Rash 4,649 12.0% 966 2,143
Pyrexia 4,364 11.2% 970 2,581
Drug hypersensitivity 4,184 10.8% 693 1,275
Pruritus 3,483 9.0% 798 1,502
Dyspnoea 3,351 8.6% 842 1,705
Fatigue 3,229 8.3% 956 1,594
Off label use 3,078 7.9% 924 2,015
Pain 3,058 7.9% 767 1,483
Hypersensitivity 2,913 7.5% 905 1,382
Joint swelling 2,691 6.9% 919 1,263
Arthralgia 2,674 6.9% 712 1,271
Infection 2,635 6.8% 876 1,299
Confusional state 2,565 6.6% 800 1,355
Peripheral swelling 2,551 6.6% 712 1,056
Nausea 2,541 6.5% 736 1,642
Sinusitis 2,519 6.5% 767 1,118
Vomiting 2,493 6.4% 881 1,514
Swelling 2,479 6.4% 845 1,266
Diarrhoea 2,456 6.3% 861 1,418

Who Reports SULFAMETHOXAZOLE\TRIMETHOPRIM Side Effects? Age & Gender Data

Gender: 56.7% female, 43.3% male. Average age: 53.8 years. Most reports from: US. View detailed demographics →

Is SULFAMETHOXAZOLE\TRIMETHOPRIM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 38 6 24
2001 26 2 23
2002 15 2 4
2003 8 0 2
2004 12 6 6
2005 9 0 6
2006 18 2 9
2007 37 7 19
2008 77 9 47
2009 61 3 39
2010 70 6 44
2011 112 15 62
2012 210 25 149
2013 275 30 177
2014 843 81 531
2015 1,045 134 675
2016 1,155 139 737
2017 1,507 145 963
2018 1,705 166 1,054
2019 1,921 129 1,192
2020 1,449 182 900
2021 1,262 120 721
2022 1,296 140 847
2023 1,416 129 841
2024 1,371 48 930
2025 639 31 441

View full timeline →

What Is SULFAMETHOXAZOLE\TRIMETHOPRIM Used For?

IndicationReports
Product used for unknown indication 12,380
Prophylaxis 3,197
Urinary tract infection 2,031
Pneumocystis jirovecii pneumonia 1,638
Antifungal prophylaxis 1,445
Infection prophylaxis 1,215
Antibiotic prophylaxis 1,107
Infection 790
Opportunistic infection prophylaxis 657
Antibiotic therapy 564

SULFAMETHOXAZOLE\TRIMETHOPRIM vs Alternatives: Which Is Safer?

SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULFANILAMIDE SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULFASALAZINE SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULFATHIAZOLE SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULFISOMIDINE SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULFUR SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULFUR HEXAFLUORIDE SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULINDAC SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULPIRIDE SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULTAMICILLIN SULFAMETHOXAZOLE\TRIMETHOPRIM vs SULTHIAME

Official FDA Label for SULFAMETHOXAZOLE\TRIMETHOPRIM

Official prescribing information from the FDA-approved drug label.