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Propylthiouracil (Propylthiouracil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Propylthiouracil 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 (21)
Death (1)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Hyperthyroidism (7)Thrombocytopenia (4)Weight Decreased (2)Nasopharyngitis (2)Head Circumference Abnormal (2)Foetal Exposure During Pregnancy (2)Tachycardia (2)Pyrexia (2)Cerebral Haemorrhage (2)Foetal Distress Syndrome (2)Fatigue (2)Antiphospholipid Syndrome (2)

Possible Propylthiouracil side effects in 83 year old male

Reported by a physician from France on 2012-08-27

Patient: 83 year old male

Reactions: Hepatic Failure, Hyperthyroidism, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clopidogrel Bisulfate and Aspirin
    Administration route: Oral

Crestor
    Administration route: Oral
    Indication: Prophylaxis

Lasix
    Administration route: Oral

Perindopril Erbumine
    Administration route: Oral
    Indication: Hypertension

Propylthiouracil
    Administration route: Oral
    Indication: Hyperthyroidism
    Start date: 2012-04-30
    End date: 2012-06-10

Other drugs received by patient: Metformin HCL; Potassium Chloride; Atenolol



Possible Propylthiouracil side effects in female

Reported by a physician from France on 2012-08-27

Patient: female

Reactions: Drug Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Administration route: Oral
    Indication: Oral Candidiasis
    Start date: 2011-08-13
    End date: 2011-08-29

Lasix
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-17

Propylthiouracil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-18
    End date: 2011-08-22

Rocephin
    Indication: Bronchitis
    Start date: 2011-08-11
    End date: 2011-08-22

Rovamycine
    Indication: Bronchitis
    Start date: 2011-08-11

Roxithromycine
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-08-16
    End date: 2011-08-23

Other drugs received by patient: Potassium Chloride; Potassium Chloride; Transipeg (France)



Possible Propylthiouracil side effects in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-09

Patient: 50 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Capillary Disorder, Pulmonary Haemorrhage, Contusion, Nasopharyngitis, Dysphonia, Oropharyngeal Pain

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Forteo
    Dosage: 20 mcg per shot in belly once a day sq
    Indication: Osteoporosis
    Start date: 2010-07-01
    End date: 2012-03-05

Propylthiouracil
    Dosage: 50 mg per tablet 3 times a day po
    Administration route: Oral
    Indication: Hyperthyroidism
    Start date: 2010-07-01
    End date: 2012-03-05



Possible Propylthiouracil side effects in 1004 month old male

Reported by a physician from France on 2012-08-06

Patient: 1004 month old male

Reactions: Cytolytic Hepatitis, Cholestasis, Hyperthyroidism, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atenolol
    Administration route: Oral
    Indication: Hypertension

Clopidogrel Bisulfate and Aspirin
    Administration route: Oral
    Indication: Prophylaxis

Crestor
    Administration route: Oral
    Indication: Prophylaxis

Lasix
    Administration route: Oral
    Indication: Hypertension

Metformin HCL
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Perindopril Erbumine
    Administration route: Oral

Propylthiouracil
    Administration route: Oral
    Indication: Hyperthyroidism
    Start date: 2012-04-30
    End date: 2012-06-10



Possible Propylthiouracil side effects in male

Reported by a physician from Saudi Arabia on 2012-08-02

Patient: male

Reactions: Maternal Drugs Affecting Foetus, Refusal of Treatment by Relative, Thyroid Disorder, Blood Thyroid Stimulating Hormone Increased, Aplasia

Drug(s) suspected as cause:
Propylthiouracil



Possible Propylthiouracil side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-05-08

Patient: 27 year old female

Reactions: Nasopharyngitis, Chills, Oropharyngeal Pain, Pyrexia, Pallor, Band Neutrophil Percentage Decreased, Oedema Mucosal, Neutrophil Percentage Decreased, Thrombocytopenia, Monocyte Percentage Increased, Epistaxis, Eosinophil Count Decreased, Haemoglobin Decreased, Agranulocytosis, Arthralgia, Hyperthyroidism, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methimazole
    Dosage: 20 mg/day
    Indication: Hyperthyroidism

Peginterferon Alfa-2A
    Dosage: 180 ug once weekly
    Indication: Hepatitis C

Propylthiouracil
    Dosage: 50 mg/day
    Indication: Hyperthyroidism

Ribavirin
    Dosage: 1.0 g/day
    Indication: Hepatitis C



Possible Propylthiouracil side effects in female

Reported by a individual with unspecified qualification from France on 2012-04-05

Patient: female

Reactions: Hyperglycaemia, Neutropenia, Hyperthyroidism, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amiodarone Hydrochloride
    Start date: 2012-01-11
    End date: 2012-02-17

Amiodarone Hydrochloride
    Indication: Atrial Fibrillation
    Start date: 2011-11-01
    End date: 2011-11-01

Carbimazole
    Indication: Hyperthyroidism
    Start date: 2012-02-05
    End date: 2012-02-07

Everolimus
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-12-17
    End date: 2012-02-07

Levofloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-07
    End date: 2012-02-15

Mycophenolate Mofetil (Cellcept)
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-11-07

Piperacillin and Piperacillin Sodium and Tazobactam Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-07
    End date: 2012-02-14

Prednisolone Sodium Metasulfobenzoate
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-02-12

Prednisone
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-12-03
    End date: 2012-02-11

Propylthiouracil
    Indication: Hyperthyroidism
    Start date: 2012-01-31
    End date: 2012-02-04

Other drugs received by patient: Bisoprolol Fumarate



Possible Propylthiouracil side effects in 68 year old female

Reported by a physician from Italy on 2012-04-05

Patient: 68 year old female

Reactions: Organising Pneumonia, Pruritus, Dyspnoea, Interstitial Lung Disease, Supraventricular Extrasystoles, Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Propylthiouracil

Other drugs received by patient: Sotalol HCL; Warfarin Sodium; Enalapril Maleate



Possible Propylthiouracil side effects in 69 year old female

Reported by a physician from France on 2012-04-05

Patient: 69 year old female

Reactions: Myelofibrosis, Reticulin Increased, Ear Haemorrhage, Petechiae, Pancytopenia, Aplasia, Platelet Count Abnormal, Bone Marrow Failure, Platelet Count Decreased, Thrombocytopenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate
    Dosage: 540 mug, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-02-01
    End date: 2011-11-17

Propylthiouracil
    Dosage: 5 unk, unk
    Administration route: Oral
    Indication: Toxic Nodular Goitre
    End date: 2012-01-23

Other drugs received by patient: Omeprazole; Atarax; Valsartan and Hydrochlorothiazide; Thyroid Therapy; Fluticasone Propionate / Salmeterol



Possible Propylthiouracil side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-03

Patient: 23 year old female

Reactions: Speech Disorder, Anxiety, Weight Decreased, Affect Lability, Chorea, Tachycardia, Maternal Exposure During Pregnancy, Dyskinesia

Drug(s) suspected as cause:
Propylthiouracil
    Indication: Toxic Nodular Goitre

Propylthiouracil
    Indication: Hyperthyroidism



Possible Propylthiouracil side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-03-29

Patient: male

Reactions: Cardiac Murmur, Head Circumference Abnormal, Motor Developmental Delay, Foetal Exposure During Pregnancy, Ileal Stenosis, Micropenis, Congenital Central Nervous System Anomaly, Exomphalos, Finger Deformity, Cerebral Haemorrhage, Foetal Distress Syndrome, Phimosis, Biliary Dilatation, Alopecia, Kidney Malformation

Drug(s) suspected as cause:
Methimazole
    Indication: Basedow's Disease

Propylthiouracil
    Indication: Basedow's Disease



Possible Propylthiouracil side effects in 57 year old female

Reported by a physician from China on 2012-03-22

Patient: 57 year old female

Reactions: Erythema Nodosum

Drug(s) suspected as cause:
Propylthiouracil



Possible Propylthiouracil side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-08

Patient: 76 year old male

Reactions: Lichenoid Keratosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Start date: 2010-10-30
    End date: 2011-12-09

Atacand
    Administration route: Oral
    End date: 2011-12-09

Plavix
    Administration route: Oral
    Start date: 2010-10-30
    End date: 2011-12-09

Propylthiouracil
    Administration route: Oral
    End date: 2011-12-14



Possible Propylthiouracil side effects in 56 year old female

Reported by a physician from United States on 2012-02-27

Patient: 56 year old female, weighing 86.6 kg (190.5 pounds)

Reactions: Fatigue, Sleep Disorder, Hepatotoxicity, Acute Hepatic Failure, Thrombocytopenia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Propylthiouracil

Other drugs received by patient: Metoprolol Succinate; Zolpidem Tartrate (Ambien CR)



Possible Propylthiouracil side effects in 43 year old female

Reported by a physician from Turkey on 2012-02-24

Patient: 43 year old female

Reactions: Dyspnoea, Acute Febrile Neutrophilic Dermatosis, Haematuria, Pancytopenia, Pyrexia, Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis, Myalgia, Agranulocytosis, Fatigue, Pleural Effusion, Hyperthyroidism

Drug(s) suspected as cause:
Propylthiouracil



Possible Propylthiouracil side effects in 27 year old male

Reported by a physician from United States on 2012-02-21

Patient: 27 year old male

Reactions: Weight Decreased, Diplopia, Activated Partial Thromboplastin Time Prolonged, Antiphospholipid Syndrome, Nystagmus, Palpitations, Embolic Stroke, Upper Motor Neurone Lesion, Temperature Intolerance, Hemianopia Homonymous, Gaze Palsy, Atrial Septal Defect, Respiratory Rate Increased, Blood Pressure Systolic Increased, Ischaemic Stroke, Hyperreflexia, Hypoaesthesia, Hypercoagulation, Antinuclear Antibody Positive, Heart Rate Increased, Insomnia, Hyperthyroidism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Propylthiouracil

Other drugs received by patient: Metoprolol Succinate



Possible Propylthiouracil side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-02-17

Patient: male

Reactions: Cardiac Murmur, Head Circumference Abnormal, Motor Developmental Delay, Micropenis, Ileal Stenosis, Foetal Exposure During Pregnancy, Congenital Central Nervous System Anomaly, Exomphalos, Cerebral Haemorrhage, Finger Deformity, Foetal Distress Syndrome, Phimosis, Biliary Dilatation, Alopecia, Kidney Malformation

Drug(s) suspected as cause:
Methimazole
    Indication: Basedow's Disease

Propylthiouracil
    Indication: Basedow's Disease



Possible Propylthiouracil side effects in 48 year old female

Reported by a individual with unspecified qualification from Denmark on 2011-12-15

Patient: 48 year old female

Reactions: Skin Ulcer, Antineutrophil Cytoplasmic Antibody Positive, Vasculitis

Drug(s) suspected as cause:
Propylthiouracil



Possible Propylthiouracil side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-20

Patient: 75 year old male

Reactions: Cytolytic Hepatitis, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    End date: 2011-05-01

Allopurinol
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-01

Augmentin '125'
    Indication: Pneumonia
    Start date: 2011-05-17
    End date: 2011-05-20

Levofloxacin
    Indication: Pyrexia
    Start date: 2011-05-16
    End date: 2011-05-17

Propylthiouracil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-05-23

Rocephin
    Indication: Pyrexia
    Start date: 2011-05-16
    End date: 2011-05-17

Rulid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2011-05-17
    End date: 2011-05-20

Other drugs received by patient: Sotalol HCL; Repaglinide; Minisintrom; Potassium Chloride; Fenofibrate; Bumetanide



Possible Propylthiouracil side effects in 43 year old female

Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-10-20

Patient: 43 year old female

Reactions: Basedow's Disease, Skin Test Positive, Ulcer, Leukocytoclastic Vasculitis, Malaise, Antiphospholipid Syndrome, Oedema Peripheral, Dermatitis Bullous, Antineutrophil Cytoplasmic Antibody Positive, Asthenia, RED Blood Cell Sedimentation Rate Increased

Drug(s) suspected as cause:
Propylthiouracil



Possible Propylthiouracil side effects in female

Reported by a consumer/non-health professional from Brazil on 2011-10-04

Patient: female

Reactions: Hyperthyroidism, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan
    Dosage: 1 df, 160 mg
    Administration route: Oral
    Start date: 2011-06-25

Diovan
    Dosage: 1 df, 80 mg
    Administration route: Oral
    Indication: Hypertension

Propylthiouracil
    Dosage: 2 df, unk
    Administration route: Oral
    Indication: Hyperthyroidism
    Start date: 2010-06-01

Propylthiouracil
    Dosage: 4 df, unk
    Administration route: Oral
    Start date: 2011-06-01

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