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Sulfamethizole Side Effects

The most commonly reported side effects of sulfamethizole include pyrexia, dyspnoea, and fatigue, based on 254 FDA adverse event reports from 2004 to 2025. 11.0% of reports found the drug to be ineffective.

Sulfamethizole side effects

Percentages show how often each reaction appears relative to total reports for sulfamethizole.

1
Pyrexia25.6%65
2
Dyspnoea21.7%55
3
Fatigue20.5%52
4
Arthralgia18.5%47
5
Sinusitis17.3%44
6
Pain15.7%40
7
Myalgia13.8%35
8
Pneumonia11.8%30
9
Infection11.4%29
10
Nasopharyngitis11.4%29
11
Stomatitis11.4%29
12
Weight Increased11.4%29
13
Fall11.0%28
14
Swelling11.0%28
15
Peripheral Swelling11.0%28

These are voluntary reports and do not establish that sulfamethizole caused these reactions.

Report severity

92.9%Serious236 reports
72.0%Hospitalizations183 reports
10.2%Fatal26 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sulfamethizole drug interactions

Other drugs that appear in adverse event reports alongside sulfamethizole. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Rituximab15.4%39
2
Prednisone12.6%32
3
Acetaminophen12.6%32
4
Methotrexate12.6%32
5
Etanercept12.2%31
6
Abatacept12.2%31
7
Adalimumab11.8%30
8
Leflunomide11.4%29
9
Tocilizumab11.4%29
10
Certolizumab-pegol11.4%29
11
Golimumab11.4%29
12
Chlorhexidine-gluconate11.0%28
13
Cetirizine-hydrochloride9.4%24
14
Diltiazem9.1%23
15
Pseudoephedrine9.1%23

Taken alongside

1
Acetaminophen21.3%54
2
Pantoprazole-sodium18.5%47
3
Ibuprofen18.1%46
4
Aspirin17.3%44
5
Ethinyl-estradiol13.0%33
6
Eszopiclone12.2%31
7
Desogestrel12.2%31
8
Metoprolol11.4%29
9
Cetirizine-hydrochloride11.0%28
10
Prednisone10.6%27
11
Hydroxychloroquine-sulfate9.4%24
12
Digitoxin9.1%23
13
Montelukast-sodium9.1%23
14
Albuterol9.1%23
15
Acyclovir8.7%22

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sulfamethizole side effects

61.4% of sulfamethizole adverse event reports involve female patients and 33.1% involve male patients. The largest age group is elderly at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female61.4%
Male33.1%
Unknown5.5%

Age group

< 20.5%
2–111.0%
12–171.0%
18–6448.1%
65+49.5%

What is sulfamethizole used for

Conditions and purposes for which patients were taking sulfamethizole when the adverse event was reported.

AcneAntifungal ProphylaxisAntibiotic ProphylaxisAntifungal ProphylaxisBacterial InfectionCystitisChronic Lymphocytic LeukaemiaChronic Lymphocytic Leukaemia RefractoryDrug Use For Unknown IndicationGlomerulonephritis Rapidly ProgressiveHyperthyroidismHypothyroidismInfection ProphylaxisProduct Used For Unknown IndicationProphylaxis

Showing 15 of 21 indications

Sulfamethizole brand names and reporting trend

Sulfamethizole is sold under the brand name Proklar.

Brand names

Proklar259

Quarterly reports (20042025)

20042010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sulfamethizole with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.