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Daraprim (Pyrimethamine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Daraprim (Pyrimethamine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (4)
Death (1)
Disability (1)

Reports by Reaction Type

Pancytopenia (2)Blood Folate Increased (1)Headache (1)Transaminases Increased (1)Haemodynamic Instability (1)Speech Disorder (1)Fatigue (1)Palpitations (1)Blindness Unilateral (1)Abdominal Distension (1)Maculopathy (1)Cardiac Murmur (1)

Possible Daraprim side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 44 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Rash Generalised, Hypophagia, Dehydration, Drug Hypersensitivity, Influenza Like Illness

Drug(s) suspected as cause:
Daraprim
    Dosage: 100 mg;x1;po 25 mg;qd;po
    Administration route: Oral
    Indication: Toxoplasmosis
    Start date: 2012-06-30
    End date: 2012-06-30

Daraprim
    Dosage: 100 mg;x1;po 25 mg;qd;po
    Administration route: Oral
    Indication: Toxoplasmosis
    Start date: 2012-07-01
    End date: 2012-07-11

Sulfadiazine
    Dosage: 2000 mg;qd;
    Indication: Toxoplasmosis
    Start date: 2012-06-30
    End date: 2012-07-11

Other drugs received by patient: Synthroid; Simvastatin



Possible Daraprim side effects in 38 year old female

Reported by a physician from Germany on 2012-07-17

Patient: 38 year old female

Reactions: Phenylketonuria, Amino Acid Level Increased, Maternal Exposure During Pregnancy, Condition Aggravated, Transaminases Increased

Drug(s) suspected as cause:
Daraprim

Other drugs received by patient: Leucovorin Calcium; Vitamin B12 + Folic Acid; Sulphadiazine; Spiramycin



Possible Daraprim side effects in 54 year old male

Reported by a physician from United States on 2012-03-20

Patient: 54 year old male

Reactions: Exophthalmos, Respiratory Disorder, Pancytopenia, Toxicity To Various Agents, Haemodynamic Instability, Mental Impairment, Zygomycosis, Bone Marrow Failure, Blindness Unilateral, Sinusitis Fungal, Eyelid Ptosis, Ophthalmoplegia, Maculopathy

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Clindamycin
    Indication: Cerebral Toxoplasmosis

Dapsone
    Indication: Antifungal Prophylaxis

Daraprim
    Indication: Cerebral Toxoplasmosis

Dexamethasone
    Indication: Brain Oedema

Other drugs received by patient: Insulin



Possible Daraprim side effects in 47 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2011-10-03

Patient: 47 year old female

Reactions: Cardiac Murmur, Mouth Ulceration, Pancytopenia, Blood Folate Increased, Headache, Accidental Overdose, Tremor, Anaemia Vitamin B12 Deficiency, Speech Disorder, Malaise, Fatigue, Palpitations, Abdominal Distension, Serum Ferritin Decreased, Asthenia

Drug(s) suspected as cause:
Daraprim

Other drugs received by patient: Fybogel Sachets

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