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Sulfadoxine Side Effects

The most commonly reported side effects of sulfadoxine include pyrexia, headache, and toxic epidermal necrolysis, based on 111 FDA adverse event reports from 2004 to 2024. 3.6% of reports found the drug to be ineffective.

#1 Reported: PyrexiaAll side effects ↓Top Co-Medication: PyrimethamineDrug interactions ↓67% of Reports Are AdultDemographics ↓

Sulfadoxine side effects

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

1
Pyrexia6.3%7
2
Headache5.4%6
3
Toxic Epidermal Necrolysis5.4%6
4
Drug Interaction4.5%5
5
Plasmodium Falciparum Infection4.5%5
6
Status Epilepticus4.5%5
7
Stevens-johnson Syndrome4.5%5
8
Grand Mal Convulsion4.5%5
9
Renal Failure Acute4.5%5
10
Hallucination4.5%5
11
Thrombocytopenia4.5%5
12
Drug Ineffective3.6%4
13
Tachycardia3.6%4
14
Tachypnoea3.6%4
15
Haemoglobin Decreased3.6%4

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

Report severity

92.8%Serious103 reports
47.7%Hospitalizations53 reports
16.2%Fatal18 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sulfadoxine drug interactions

Other drugs that appear in adverse event reports alongside sulfadoxine. 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
Pyrimethamine43.2%48
2
Tenofovir11.7%13
3
Emtricitabine10.8%12
4
Cyclosporine10.8%12
5
Quinine-sulfate7.2%8
6
Ritonavir5.4%6
7
Atazanavir-sulfate5.4%6
8
Phenytoin5.4%6
9
Voriconazole5.4%6
10
Nevirapine4.5%5
11
Foscarnet-sodium4.5%5
12
Posaconazole4.5%5
13
Methyldopa4.5%5
14
Folic-acid4.5%5
15
Efavirenz3.6%4

Taken alongside

1
Pyrimethamine45.0%50
2
Prednisone15.3%17
3
Acetaminophen11.7%13
4
Posaconazole7.2%8
5
Folic-acid6.3%7
6
Hydroxyzine6.3%7
7
Topiramate5.4%6
8
Valproate-sodium5.4%6
9
Sulfamethoxazole5.4%6
10
Trimethoprim5.4%6
11
Amoxicillin5.4%6
12
Ferrous-sulfate5.4%6
13
Esomeprazole5.4%6
14
Alprazolam4.5%5
15
Methylprednisolone3.6%4

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 sulfadoxine side effects

52.3% of sulfadoxine adverse event reports involve female patients and 43.2% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female52.3%
Male43.2%
Unknown4.5%

Age group

< 214.0%
2–119.3%
12–173.5%
18–6467.4%
65+5.8%

What is sulfadoxine used for

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

Anticoagulant TherapyCerebral MalariaCytomegalovirus InfectionDrug Use For Unknown IndicationEye Infection ToxoplasmalFoetal Exposure During PregnancyFoetal Exposure During PregnancyInfection ProphylaxisLiver TransplantMalariaMalaria ProphylaxisMalaria ProphylaxisPlasmodium Falciparum InfectionProduct Used For Unknown IndicationProphylaxis

Showing 15 of 20 indications

Sulfadoxine brand names and reporting trend

Sulfadoxine is sold under the brand name Fansidar.

Brand names

Fansidar35

Quarterly reports (2004–2024)

20042010201520202024

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

Taking sulfadoxine with another medication?

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