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Primaquine Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 31, 2023.

Applies to primaquine: oral tablet.

Warning

Oral route (Tablet)

Physicians should completely familiarize themselves with the complete contents of this leaflet before prescribing primaquine phosphate.

Serious side effects of Primaquine

Along with its needed effects, primaquine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking primaquine:

Incidence not known

Other side effects of Primaquine

Some side effects of primaquine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to primaquine: compounding powder, oral tablet.

Hematologic

Hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) and methemoglobinemia in patients with nicotinamide adenine dinucleotide methemoglobin reductase deficiency have been reported.

Patients from Africa, Southern Europe, Mediterranean region, Middle East, Southeast Asia, and Oceania had a greater tendency to develop hemolytic anemia (due to congenital deficiency of erythrocytic G6PD) while using this drug.

Leukopenia and agranulocytosis have been reported in patients taking very high doses (120 mg/day for 14 days).[Ref]

Frequency not reported: Hemolytic anemia, hemolysis, methemoglobinemia, leukopenia, agranulocytosis, mild anemia, leukocytosis, neutropenia[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal cramps, abdominal pains

Frequency not reported: Epigastric distress[Ref]

Gastrointestinal symptoms were dose related.[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Cardiovascular

Frequency not reported: Cardiac arrhythmia, QT interval prolongation, hypertension[Ref]

Metabolic

Frequency not reported: Increased methemoglobin level

Hypersensitivity

Hypersensitivity skin rashes have been reported in AIDS patients using this drug with clindamycin for treatment of Pneumocystis pneumonia.[Ref]

Frequency not reported: Hypersensitivity skin rashes[Ref]

References

1. Ziai M, Amirhakimi GH, Reinhold JG, Tabatabee M, Gettner ME, Bowman JE. Malaria prophylaxis and treatment in G-6-PD deficiency. An observation on the toxicity of primaquine and chloroquine. Clin Pediatr (Phila). 1967;6:42-3.

2. George JN, Sears DA, McCurdy PR, Conrad ME. Primaquine sensitivity in Caucasians: hemolytic reactions induced by primaquine in G-6-PD deficient subjects. J Lab Clin Med. 1967;70:0-93.

3. Reeve PA, Toaliu H, Kaneko A, Hall JJ, Ganczakowski M. Acute intravascular haemolysis in Vanuatu following a single dose of primaquine in individuals with glucose-6-phosphate dehydrogenase deficiency. J Trop Med Hyg. 1992;95:49-51.

4. Kantor GS. Primaquine-induced methemoglobinemia during treatment of Pneumocystis carinii pneumonia . N Engl J Med. 1992;327:461.

5. Kay R, DuBois RE. Clindamycin/primaquine therapy and secondary prophylaxis against Pneumocystis carinii pneumonia in patients with AIDS. South Med J. 1990;83:03-4.

6. Ruf B, Rohde I, Pohle HD. Efficacy of clindamycin/primaquine versus trimethoprim/sulfamethoxazole in primary treatment of Pneumocystis carinii pneumonia. Eur J Clin Microbiol Infect Dis. 1991;10:07-10.

7. Product Information. Primaquine (primaquine). Sanofi Winthrop Pharmaceuticals. 2001;PROD.

8. Fryauff DJ, Baird JK, Basri H, Sumawinata I, Purnomo, Richie TL, Ohrt CK, Mouzin E, Church CJ, Richards AL, Subianto B, Sand. Randomised placebo-controlled trial of primaquine for prophylaxis of falciparum and vivax malaria. Lancet. 1995;346:1190-3.

9. Bolchoz LJC, Budinsky RA, McMillan DC, Jollow DJ. Primaquine-induced hemolytic anemia: formation and hemotoxicity of the arylhydroxylamine metabolite 6-methoxy-8-hydroxylaminoquinoline. J Pharmacol Exp Ther. 2001;297:509-15.

10. Cerner Multum, Inc. Australian Product Information.

11. Freedman DO. Clinical practice. Malaria prevention in short-term travelers. N Engl J Med. 2008;359:603-12.

12. World Health Organization. Guidelines for the Treatment of Malaria – Third edition. http://apps.who.int/iris/bitstream/10665/162441/1/9789241549127_eng.pdf?ua=1 2015.

13. Baird JK, Fryauff DJ, Basri H, Bangs MJ, Subianto B, Wiady I, Purnomo, Leksana B, Masbar S, Richie TL, Jones TR, Tjitra E,. Primaquine for prophylaxis against malaria among nonimmune transmigrants in irian jaya, indonesia. Am J Trop Med Hyg. 1995;52:479-84.

14. Black JR, Feinberg J, Murphy RL, Fass RJ, Finkelstein D, Akil B, Safrin S, Carey JT, Stansell J, Plouffe JF, He WL, Shelto. Clindamycin and primaquine therapy for mild-to-moderate episodes of pneumocystis carinii pneumonia in patients with AIDS: AIDS clinical trials group 044. Clin Infect Dis. 1994;18:905-13.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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