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
- Back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- bluish-colored lips, fingernails, or palms
- chest pain
- chills
- cough
- dark urine
- difficulty breathing
- dizziness, faintness, or lightheadedness
- fast, slow, pounding, or irregular heartbeat
- fever
- general body swelling
- headache
- loss of appetite
- nausea or vomiting
- nosebleeds
- painful or difficult urination
- pale skin
- rapid heart rate
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellowing of the eyes or skin
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
- Heartburn
- itching, skin rash
- pain or discomfort in the chest, upper stomach, or throat
- stomach cramps
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]
