Note: This document contains side effect information about pyrimethamine. Some dosage forms listed on this page may not apply to the brand name Daraprim.
Applies to pyrimethamine: oral tablet.
Serious side effects of Daraprim
Along with its needed effects, pyrimethamine (the active ingredient contained in Daraprim) 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 pyrimethamine:
Rare
- Chest pain
- dry cough
- fever
- rapid or trouble breathing
- skin rash
- unusual tiredness or weakness
Incidence not known
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chills
- cough
- diarrhea
- difficulty swallowing
- dizziness
- fainting spells
- fast or irregular heartbeat
- hives, itching
- irritation or soreness of the tongue
- joint or muscle pain
- lower back or side pain
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- red, irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tightness in the chest
- unusual bleeding or bruising
Other side effects of Daraprim
Some side effects of pyrimethamine 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:
Incidence not known
- Loss of appetite
- vomiting
- weight loss
For Healthcare Professionals
Applies to pyrimethamine: compounding powder, oral tablet.
General
Since this drug is coadministered with a sulfonamide, the manufacturer product information for the relevant sulfonamide should be consulted for sulfonamide-related side effects.[Ref]
Gastrointestinal
Very common (10% or more): Nausea, vomiting, diarrhea, colic
Uncommon (0.1% to 1%): Dry mouth, dry throat
Very rare (less than 0.01%): Buccal ulceration
Frequency not reported: Glossitis, atrophic glossitis[Ref]
Nervous system
Precipitation of a grand mal attack in a patient predisposed to epilepsy was reported; clinical significance was not established.[Ref]
Very common (10% or more): Headache
Common (1% to 10%): Dizziness
Very rare (less than 0.01%): Convulsions/seizures
Frequency not reported: Ataxia, tremors, precipitation of grand mal attack[Ref]
Hematologic
Very common (10% or more): Anemia
Common (1% to 10%): Thrombocytopenia, leukopenia
Very rare (less than 0.01%): Pancytopenia
Frequency not reported: Megaloblastic anemia, neutropenia, agranulocytosis[Ref]
Dermatologic
Very common (10% or more): Rash
Uncommon (0.1% to 1%): Abnormal skin pigmentation, dermatitis
Other
Uncommon (0.1% to 1%): Fever, malaise
Psychiatric
Insomnia was reported when this drug was given weekly at higher than recommended doses.
Uncommon (0.1% to 1%): Depression
Very rare (less than 0.01%): Insomnia
Respiratory
Rare (0.01% to 0.1%): Pulmonary eosinophilia
Very rare (less than 0.01%): Pneumonia with cellular and eosinophilic pulmonary infiltration[Ref]
Pneumonia with cellular and eosinophilic pulmonary infiltration was observed when this drug was administered once a week with sulfadoxine.[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions (included erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, Lyell's syndrome, hepatitis, anaphylaxis, pulmonary reactions, maculopapular rashes)[Ref]
Cardiovascular
Circulatory collapse was reported in patients treated with higher than recommended doses.[Ref]
Very rare (less than 0.01%): Circulatory collapse
Frequency not reported: Disorders of cardiac rhythm, arrhythmias[Ref]
Metabolic
Hyperphenylalaninemia was reported in neonates treated for congenital toxoplasmosis.[Ref]
Very rare (less than 0.01%): Hyperphenylalaninemia
Frequency not reported: Anorexia[Ref]
Genitourinary
Very rare (less than 0.01%): Hematuria
Oncologic
A 51-year-old female developed chronic granulocytic leukemia after taking this drug for 2 years for toxoplasmosis and a 56-year-old patient developed reticulum cell sarcoma after taking this drug for 14 months for toxoplasmosis.[Ref]
Frequency not reported: Chronic granulocytic leukemia, reticulum cell sarcoma[Ref]
