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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.

SULFADIAZINE\TRIMETHOPRIM: 186 Adverse Event Reports & Safety Profile

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186
Total FAERS Reports
41 (22.0%)
Deaths Reported
152
Hospitalizations
186
As Primary/Secondary Suspect
63
Life-Threatening
8
Disabilities

First Report: 19961201 · Latest Report: 20250305

What Are the Most Common SULFADIAZINE\TRIMETHOPRIM Side Effects?

#1 Most Reported
Somnolence
84 reports (45.2%)
#2 Most Reported
Pneumonia aspiration
84 reports (45.2%)
#3 Most Reported
Gastrooesophageal reflux disease
84 reports (45.2%)

All SULFADIAZINE\TRIMETHOPRIM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Coma 84 45.2% 0 82
Gastrooesophageal reflux disease 84 45.2% 0 82
Pneumonia aspiration 84 45.2% 0 82
Somnolence 84 45.2% 0 82
Anxiety 67 36.0% 30 48
Dyspnoea 60 32.3% 31 53
Condition aggravated 57 30.7% 31 50
Obstructive airways disorder 57 30.7% 30 49
Lung disorder 56 30.1% 31 49
Wheezing 56 30.1% 31 46
Asthma 55 29.6% 30 48
Haemoptysis 55 29.6% 30 48
Neuritis 55 29.6% 30 48
Neurological symptom 55 29.6% 30 48
Pain in extremity 55 29.6% 30 48
Pulmonary alveolar haemorrhage 55 29.6% 30 48
Pulmonary fibrosis 55 29.6% 30 48
Therapeutic product effect incomplete 55 29.6% 28 48
Pulmonary vasculitis 54 29.0% 29 47
Full blood count abnormal 53 28.5% 30 48

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

Gender: 60.6% female, 39.4% male. Average age: 62.8 years. Most reports from: CA. View detailed demographics →

Is SULFADIAZINE\TRIMETHOPRIM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2015 1 0 0
2016 1 0 0
2018 2 0 2
2025 1 0 1

View full timeline →

What Is SULFADIAZINE\TRIMETHOPRIM Used For?

IndicationReports
Product used for unknown indication 148
Stomatitis 14
Rheumatoid arthritis 5

SULFADIAZINE\TRIMETHOPRIM vs Alternatives: Which Is Safer?

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

Official FDA Label for SULFADIAZINE\TRIMETHOPRIM

Official prescribing information from the FDA-approved drug label.