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Primaquine Side Effects

The most commonly reported side effects of primaquine include methaemoglobinaemia, off label use, and drug interaction, based on 448 FDA adverse event reports from 2004 to 2025. 9.8% of reports found the drug to be ineffective.

Primaquine side effects

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

1
Methaemoglobinaemia14.1%63
2
Drug Ineffective9.8%44
3
Off Label Use9.2%41
4
Drug Interaction8.0%36
5
Pneumocystis Jirovecii Pneumonia7.8%35
6
Pyrexia5.6%25
7
Respiratory Failure5.4%24
8
Dyspnoea4.7%21
9
Condition Aggravated4.2%19
10
Haemolysis3.6%16
11
Vomiting3.1%14
12
Acute Kidney Injury3.1%14
13
Acute Respiratory Distress Syndrome2.9%13
14
Nausea2.9%13
15
Anaemia2.9%13

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

Report severity

92.6%Serious415 reports
51.6%Hospitalizations231 reports
18.1%Fatal81 reports

Seriousness is determined by the reporter, not by OpenClaim.

Primaquine drug interactions

Other drugs that appear in adverse event reports alongside primaquine. 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
Clindamycin16.7%75
2
Sulfamethoxazole9.2%41
3
Trimethoprim8.0%36
4
Hydroxychloroquine-sulfate8.0%36
5
Mycophenolate5.8%26
6
Tacrolimus5.4%24
7
Dapsone4.7%21
8
Rituximab4.7%21
9
Mefloquine-hydrochloride4.5%20
10
Prednisolone4.5%20
11
Prednisone4.0%18
12
Chloroquine3.6%16
13
Atovaquone3.3%15
14
Methylprednisolone3.3%15
15
Artesunate2.7%12

Taken alongside

1
Clindamycin35.7%160
2
Methylprednisolone10.0%45
3
Prednisone9.4%42
4
Acetaminophen8.3%37
5
Sulfamethoxazole7.8%35
6
Azithromycin7.4%33
7
Trimethoprim6.9%31
8
Pantoprazole-sodium6.7%30
9
Furosemide6.5%29
10
Cefepime-hydrochloride6.5%29
11
Meropenem6.3%28
12
Fluconazole6.0%27
13
Ceftriaxone-sodium6.0%27
14
Doxycycline5.6%25
15
Omeprazole5.6%25

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 primaquine side effects

28.1% of primaquine adverse event reports involve female patients and 63.2% involve male patients. The largest age group is adult at 75%. These figures reflect who reports side effects, not underlying risk.

Sex

Female28.1%
Male63.2%
Unknown8.7%

Age group

< 20.5%
2–112.6%
12–173.1%
18–6475.0%
65+18.8%

What is primaquine used for

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

Anti-infective TherapyAntibiotic ProphylaxisAntifungal ProphylaxisAcute Myeloid LeukaemiaAntibiotic TherapyAntiretroviral TherapyBronchopulmonary AspergillosisChronic Lymphocytic LeukaemiaCondition AggravatedCovid-19Cytomegalovirus Test PositiveDrug Use For Unknown IndicationDrug Reaction With Eosinophilia And Systemic SymptomsEvidence Based TreatmentEvidence Based Treatment

Showing 15 of 57 indications

Primaquine brand names and reporting trend

Primaquine is sold under the brand name Primaquine.

Brand names

Primaquine101

Quarterly reports (20042025)

20042010201520202025

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

Taking primaquine with another medication?

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