This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Danazol 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 (22)
Disability (3)
Reports by Reaction Type
Liver Disorder (4),
Abdominal Pain (3),
Blood Lactate Dehydrogenase Increased (3),
Rhabdomyolysis (2),
Drug Interaction (2),
Constipation (2),
Interstitial Lung Disease (2),
Hereditary Angioedema (2),
White Blood Cell Count Increased (2),
Alanine Aminotransferase Increased (2),
International Normalised Ratio Increased (2),
Hyponatraemia (2)
Possible Danazol side effects in female
Reported by a physician from Japan on 2012-08-23
Patient: female
Reactions: Haemoglobin Decreased, White Blood Cell Count Decreased, Platelet Count Decreased, Purpura, LIP Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mircera
Indication: Nephrogenic Anaemia
Start date: 2012-03-03
End date: 2012-03-03
Allopurinol
Administration route: Oral
Indication: Hyperuricaemia
Start date: 2012-02-04
End date: 2012-03-02
Nespo
Dosage: dosage is uncertain.
Indication: Nephrogenic Anaemia
Start date: 2011-10-01
End date: 2012-01-01
Danazol
Administration route: Oral
Indication: Aplastic Anaemia
End date: 2012-03-01
Other drugs received by patient: Torsemide; Juvela; Diovan; Lasix; Adalat CC; Primobolan-Depot INJ
Possible Danazol side effects in 46 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06
Patient: 46 year old female
Reactions: Abdominal Pain, Aspartate Aminotransferase Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Hereditary Angioedema, Hyponatraemia, Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Danazol
Indication: Product Used FOR Unknown Indication
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-18
End date: 2012-04-18
Opioids
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Cinryze; Dilantin; Coumadin
Possible Danazol side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: 46 year old female
Reactions: Abdominal Pain, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Aspartate Aminotransferase Increased, Hyponatraemia, Hereditary Angioedema, Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Opioids
Indication: Product Used FOR Unknown Indication
Danazol
Indication: Product Used FOR Unknown Indication
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-18
End date: 2012-04-18
Kalbitor
Start date: 2012-06-21
End date: 2012-06-21
Other drugs received by patient: Coumadin; Cinryze; Dilantin
Possible Danazol side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19
Patient: 32 year old female
Reactions: Weight Increased, Acne, Alopecia, Aggression, Nervousness, Tremor
Drug(s) suspected as cause:
Danazol
Possible Danazol side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female
Reactions: Depression
Drug(s) suspected as cause:
Cinryze
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Firazyr
Dosage: unk, unknown
Indication: Hereditary Angioedema
Danazol
Dosage: unk unk, unknown
Indication: Product Used FOR Unknown Indication
End date: 2010-01-01
Possible Danazol side effects in female
Reported by a physician from Japan on 2012-06-08
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Blood Lactate Dehydrogenase Increased, Liver Disorder
Drug(s) suspected as cause:
Danazol
Dosage: 100mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-09-12
Other drugs received by patient: Prednisolone; Lansoprazole
Possible Danazol side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female, weighing 68.6 kg (150.8 pounds)
Reactions: Abdominal Pain, Systemic Candida, Lactobacillus Infection, Drug Ineffective, Device Related Infection, Corynebacterium Sepsis, Microcytic Anaemia, Off Label Use, Pneumonia Klebsiella, Abdominal Distension, Staphylococcal Bacteraemia, Bacillus Infection, Venous Thrombosis Limb, Candidiasis, Renal Failure Acute, Angioedema, Streptococcal Infection, Staphylococcal Sepsis, Alpha Haemolytic Streptococcal Infection, Bacteraemia, Presyncope
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Berinert
Indication: Angioedema
End date: 2012-03-18
Danazol
Administration route: Oral
Start date: 2012-03-01
End date: 2012-03-18
Cinryze
Indication: Angioedema
End date: 2012-03-18
Danazol
Administration route: Oral
Indication: Angioedema
End date: 2012-03-01
Other drugs received by patient: Micafungin; Vancomycin; Hydrocortisone; Hydrocortisone; Albuterol
Possible Danazol side effects in 56 year old male
Reported by a pharmacist from United States on 2012-05-18
Patient: 56 year old male, weighing 93.5 kg (205.7 pounds)
Reactions: Blood Bilirubin Increased, Jaundice, International Normalised Ratio Abnormal, Chromaturia, Hypokalaemia, Faeces Discoloured, Hepatic Enzyme Increased, Malaise, Ocular Icterus, Asthenia, Blood Creatinine Increased, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Danazol
Possible Danazol side effects in 85 year old female
Reported by a physician from Japan on 2012-05-17
Patient: 85 year old female
Reactions: Productive Cough, Sepsis, Urinary Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Danazol
Dosage: 400 mg, qd
Start date: 2011-11-07
Soliris
Indication: Paroxysmal Nocturnal Haemoglobinuria
Other drugs received by patient: Neoral; Warfarin Sodium; Blood Transfusion, Auxiliary Products; Platelets; Warfarin Sodium; Alfarol; Neoral; Neoral; Folamin; Prednisolone; Neoral; Acetaminophen; Desferal; Platelets
Possible Danazol side effects in female
Reported by a physician from Japan on 2012-05-14
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Blood Lactate Dehydrogenase Increased, Liver Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-09-12
Danazol
Dosage: 100mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Other drugs received by patient: Prednisolone; Lansoprazole
Possible Danazol side effects in female
Reported by a physician from Japan on 2012-05-04
Patient: female
Reactions: Liver Disorder, White Blood Cell Count Increased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Prednisolone Acetate
Dosage: 22.5mg per day
Administration route: Oral
Start date: 2011-04-11
End date: 2011-04-24
Promacta
Dosage: 12.5mg per day
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-03-22
End date: 2011-05-29
Promacta
Dosage: 25mg per day
Start date: 2011-05-30
Prednisolone Acetate
Dosage: 9mg per day
Administration route: Oral
Start date: 2011-07-04
End date: 2011-08-07
Prednisolone Acetate
Dosage: 6mg per day
Administration route: Oral
Start date: 2011-09-05
End date: 2012-01-12
Danazol
Dosage: 100mg per day
Administration route: Oral
Start date: 2012-03-05
Prednisolone Acetate
Dosage: 5mg per day
Administration route: Oral
Start date: 2012-01-13
Prednisolone Acetate
Dosage: 25mg per day
Administration route: Oral
Start date: 2011-03-28
End date: 2011-04-10
Prednisolone Acetate
Dosage: 7mg per day
Administration route: Oral
Start date: 2011-08-08
End date: 2011-09-04
Prednisolone Acetate
Dosage: 10mg per day
Administration route: Oral
Start date: 2011-06-20
End date: 2011-07-03
Danazol
Dosage: 100mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-09-05
End date: 2011-11-13
Prednisolone Acetate
Dosage: 20mg per day
Administration route: Oral
Start date: 2011-04-25
End date: 2011-05-08
Prednisolone Acetate
Dosage: 12mg per day
Administration route: Oral
Start date: 2011-06-06
End date: 2011-06-19
Prednisolone Acetate
Dosage: 30mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
End date: 2011-03-27
Prednisolone Acetate
Dosage: 15mg per day
Administration route: Oral
Start date: 2011-05-09
End date: 2011-06-05
Danazol
Dosage: 200mg per day
Administration route: Oral
Start date: 2011-11-14
End date: 2012-03-04
Other drugs received by patient: Levofloxacin; Loxonin; Zantac; Meiact; Flomox; Risedronate Sodium
Possible Danazol side effects in female
Reported by a physician from Japan on 2012-05-01
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Blood Lactate Dehydrogenase Increased, Liver Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Danazol
Dosage: 100mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-09-12
Other drugs received by patient: Prednisolone; Lansoprazole
Possible Danazol side effects in male
Reported by a pharmacist from Canada on 2012-03-12
Patient: male
Reactions: Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rituxan
Indication: Anaemia Haemolytic Autoimmune
Danazol
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Calcium; Levothyroxine Sodium; Folic Acid; Advair Diskus 100 / 50; Diltiazem; Furosemide; Nitroglycerin; Prednisone; Naproxen; Vitamin B-12; Actonel; Ventolin; Perindopril Erbumine; Lipitor; Rabeprazole Sodium; Aspirin; Spiriva
Possible Danazol side effects in 81 year old female
Reported by a physician from Japan on 2012-03-01
Patient: 81 year old female
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Dosage: 12.5mg twice per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-12-01
Nateglinide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cepharanthine
Indication: Product Used FOR Unknown Indication
Danazol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lendormin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Prednisolone
Indication: Product Used FOR Unknown Indication
Possible Danazol side effects in 37 year old male
Reported by a health professional (non-physician/pharmacist) from India on 2012-02-28
Patient: 37 year old male
Reactions: Fatigue, Disease Recurrence, Dizziness, Aplasia Pure RED Cell
Drug(s) suspected as cause:
Cyclosporine
Indication: Aplasia Pure RED Cell
Anti-Thymocyte Globulin Equine NOS
Mycophenolate Mofetil
Indication: Aplasia Pure RED Cell
Danazol
Indication: Aplasia Pure RED Cell
Other drugs received by patient: Azathioprine; Prednisolone
Possible Danazol side effects in 81 year old female
Reported by a physician from Japan on 2012-02-14
Patient: 81 year old female
Reactions: Interstitial Lung Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nateglinide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Promacta
Dosage: 12.5mg twice per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-12-01
Danazol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cepharanthine
Indication: Product Used FOR Unknown Indication
Lendormin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Prednisolone
Indication: Product Used FOR Unknown Indication
Possible Danazol side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-30
Patient: 60 year old female
Reactions: Cardiac Failure, Interstitial Lung Disease, Pleural Effusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ramipril
Dosage: 2.5 mg, 1x/day
Administration route: Oral
Start date: 2009-08-01
End date: 2009-12-01
Prednisolone
Dosage: 5 mg, 1x/day
Administration route: Oral
Start date: 2009-09-01
Mabthera
Dosage: unk
Start date: 2009-01-02
End date: 2009-04-29
Amiodarone HCL
Dosage: 200 mg, 1x/day
Administration route: Oral
Start date: 2009-08-01
Danazol
Dosage: unk
Start date: 2009-11-01
End date: 2009-11-01
Valaciclovir
Dosage: 500 mg, 2x/day
Administration route: Oral
Start date: 2009-01-01
End date: 2009-12-01
Other drugs received by patient: Primperan TAB; Spiramycin; Aspirin; Nexium; Isosorbide Dinitrate; Furosemide
Possible Danazol side effects in 91 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-24
Patient: 91 year old male, weighing 73.0 kg (160.6 pounds)
Reactions: Rhabdomyolysis, Drug Interaction
Drug(s) suspected as cause:
Danazol
Dosage: 400 mg;qd
Lovastatin
Dosage: 40 mg;qd
Other drugs received by patient: Glipizide; Metoprolol Tartrate; Simvastatin; Clopidogrel; Atorvastatin; Fluvastatin; Aspirin; Isosorbide Dinitrate; Levothyroxine Sodium; Lisinopril
Possible Danazol side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-04
Patient: 75 year old male
Reactions: Pulmonary Fibrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Danazol
Other drugs received by patient: Diltiazem HCL; Bumetanide; Digoxin
Possible Danazol side effects in 91 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-03
Patient: 91 year old male, weighing 73.0 kg (160.6 pounds)
Reactions: Renal Impairment, Rhabdomyolysis, Drug Interaction, White Blood Cell Count Increased
Drug(s) suspected as cause:
Danazol
Dosage: 400 mg;qd;unk
Indication: Idiopathic Thrombocytopenic Purpura
Lovastatin
Dosage: 40 mg;qd;unk
Other drugs received by patient: Isosorbide Dinitrate; Clopidogrel; Metoprolol Succinate; Glipizide; Levothyroxine Sodium; Lisinopril; Aspirin
Possible Danazol side effects in 47 year old female
Reported by a physician from Switzerland on 2011-11-29
Patient: 47 year old female
Reactions: Hepatocellular Injury
Drug(s) suspected as cause:
Danazol
Other drugs received by patient: Tramadol Hydrochloride; ALL Other Therapeutic Products; Calcimagon; Fosamax; Livial
Possible Danazol side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2011-11-04
Patient: 72 year old female
Reactions: Blood Creatine Phosphokinase Increased, Hypoglycaemia, Bundle Branch Block Left, Hyperhidrosis, Medication Error, Chest Pain, Presyncope, Troponin I Increased, Asthenia, Myocardial Infarction, Drug Dispensing Error
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Glyburide
Danazol
Indication: Idiopathic Thrombocytopenic Purpura
Other drugs received by patient: Perindopril Erbumine; Levothyroxine Sodium
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