This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nizoral (Ketoconazole) 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 (40)
Death (5)
Life Threatening Events (2)
Reports by Reaction Type
Nausea (5),
Asthenia (5),
Intentional Drug Misuse (4),
Hepatitis (4),
Off Label Use (4),
Pain in Extremity (4),
Hepatic Function Abnormal (3),
Drug Ineffective (3),
Gastritis (3),
Myalgia (3),
Death (3),
Fatigue (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Nizoral (Ketoconazole). For a complete list or a specific selection of reports, please use the links above.
Possible Nizoral side effects in 57 year old female
Reported by a physician from United States on 2012-08-06
Patient: 57 year old female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Alcohol
Dosage: unk
Ambien
Dosage: unk
Caffeine Citrate
Dosage: unk
Ceclor
Dosage: unk
Ceftin
Dosage: unk
Ciprofloxacin HCL
Dosage: unk
Cleocin Hydrochloride
Dosage: unk
Compazine
Dosage: unk
Duricef
Dosage: unk
Epinephrine
Dosage: unk
Gadolinium
Dosage: unk
Heparin
Dosage: unk
Indocin
Dosage: unk
Iodine
Dosage: unk
Monistat
Dosage: unk
Mycelex
Dosage: unk
Nizoral
Dosage: unk
Oxymetazoline HCL
Dosage: unk
Relafen
Dosage: unk
Possible Nizoral side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23
Patient: 45 year old female
Reactions: Visual Acuity Reduced, Chromaturia, Transaminases Increased, Diarrhoea, Gamma-Glutamyltransferase Increased, DRY Mouth, Asthenia, DRY Eye
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Chlormadinone Acetate TAB
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Irbesartan
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Januvia
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-05-01
End date: 2010-06-01
Nizoral
Administration route: Oral
Start date: 2010-12-18
Nizoral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-01-14
Possible Nizoral side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-20
Patient: 45 year old female
Reactions: Visual Acuity Reduced, Chromaturia, Transaminases Increased, Gamma-Glutamyltransferase Increased, Diarrhoea, DRY Mouth, DRY Eye, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Chlormadinone Acetate TAB
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Irbesartan
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Januvia
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-05-01
End date: 2010-06-01
Nizoral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-01-14
Nizoral
Administration route: Oral
Start date: 2010-12-18
Possible Nizoral side effects in
Reported by a pharmacist from Japan on 2012-07-09
Patient:
Reactions: Off Label Use, Ulcer
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in 60 year old female
Reported by a physician from Belgium on 2012-07-09
Patient: 60 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Nizoral
Administration route: Oral
Indication: Alopecia
Start date: 2012-03-23
End date: 2012-05-01
Seroquel
Dosage: started before nov-2008
Administration route: Oral
Indication: Schizoaffective Disorder
Possible Nizoral side effects in 60 year old female
Reported by a physician from Belgium on 2012-07-02
Patient: 60 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Nizoral
Administration route: Oral
Nizoral
Administration route: Oral
Indication: Alopecia
Start date: 2012-03-23
End date: 2012-05-01
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Schizoaffective Disorder
Possible Nizoral side effects in 48 year old female
Reported by a physician from China on 2012-06-05
Patient: 48 year old female
Reactions: Colitis Ischaemic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in male
Reported by a physician from China on 2012-05-25
Patient: male, weighing 46.0 kg (101.2 pounds)
Reactions: Neutrophil Count Increased, Rash Generalised, RED Blood Cell Count Increased, Urticaria, Chills, Pyrexia, Pruritus Generalised, Flushing, Asthenia
Drug(s) suspected as cause:
Nizoral
Administration route: Oral
Indication: Infection
Start date: 2011-05-02
End date: 2011-05-02
Nizoral
Administration route: Oral
Indication: Tinea Pedis
Start date: 2011-05-02
End date: 2011-05-02
Possible Nizoral side effects in female
Reported by a pharmacist from China on 2012-05-25
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Drug-Induced Liver Injury, Cholecystitis, Intentional Drug Misuse, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Dosage: 26-jul, first box
Administration route: Oral
Indication: Onychomycosis
Start date: 2011-07-26
Nizoral
Dosage: 2 boxes in aug (year unspecified)
Administration route: Oral
End date: 2011-09-06
Possible Nizoral side effects in 60 year old female
Reported by a physician from Belgium on 2012-05-07
Patient: 60 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Nizoral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Possible Nizoral side effects in male
Reported by a pharmacist from China on 2012-05-03
Patient: male
Reactions: Liver Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Administration route: Oral
Indication: Vitamin B1 Deficiency
Start date: 2011-10-13
End date: 2011-10-28
Nizoral
Administration route: Oral
Indication: Tinea Pedis
Start date: 2011-10-13
End date: 2011-10-28
Possible Nizoral side effects in female
Reported by a physician from China on 2012-05-03
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Abdominal Pain, Regurgitation, Hepatic Pain, Nausea, Musculoskeletal Pain, Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in female
Reported by a consumer/non-health professional from China on 2012-05-03
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Subacute Hepatic Failure, Hepatic Encephalopathy, Disseminated Intravascular Coagulation, Dizziness, Hepatitis, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nizoral
Other drugs received by patient: Unknown Medication; Unknown Medication; Methylprednisolone; Alprostadil; Glutathione; Methylprednisolone; Unknown Medication; Alprostadil; Glycyrrhizic Acid, Ammonium Salt; Glutathione; Glycyrrhizic Acid, Ammonium Salt; Unknown Medication; Unknown Medication
Possible Nizoral side effects in 40 year old male
Reported by a consumer/non-health professional from China on 2012-05-03
Patient: 40 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Sexual Dysfunction, Priapism, Intentional Drug Misuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Administration route: Oral
Start date: 2011-03-01
End date: 2011-03-21
Nizoral
Administration route: Oral
Indication: Onychomycosis
Start date: 2011-01-01
Nizoral
Administration route: Oral
Start date: 2010-12-21
Possible Nizoral side effects in female
Reported by a pharmacist from China on 2012-05-02
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Cholecystitis, Intentional Drug Misuse, Hepatitis, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Dosage: 26-jul, first box
Administration route: Oral
Indication: Onychomycosis
Start date: 2011-07-26
Nizoral
Dosage: 2 boxes in aug (year unspecified)
Administration route: Oral
End date: 2011-09-06
Possible Nizoral side effects in female
Reported by a health professional (non-physician/pharmacist) from China on 2012-04-30
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Subacute Hepatic Failure, Hepatic Encephalopathy, Disseminated Intravascular Coagulation, Dizziness, Hepatitis, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nizoral
Dosage: possibly for 10 days and taken about 10 tablets
Administration route: Oral
Indication: Onychomycosis
Start date: 2011-03-17
Nizoral
Dosage: approximately 10 days
Administration route: Oral
Start date: 2011-06-17
Other drugs received by patient: Unknown Medication; Methylprednisolone; Glycyrrhizic Acid, Ammonium Salt; Alprostadil; Alprostadil; Glutathione; Glutathione; Glycyrrhizic Acid, Ammonium Salt; Unknown Medication; Unknown Medication; Methylprednisolone; Unknown Medication; Unknown Medication
Possible Nizoral side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-08
Patient: female
Reactions: Myoclonus, Off Label Use, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metopirone
Administration route: Oral
Start date: 2011-01-06
Metopirone
Administration route: Oral
Start date: 2011-01-01
Metopirone
Dosage: 2 tablets in morning, 1 tablet at mid day, 1 tablet at the evening and 2 tablets at bed time.
Administration route: Oral
Start date: 2012-01-01
Metopirone
Administration route: Oral
Indication: Hypercorticoidism
Metopirone
Administration route: Oral
Start date: 2011-03-28
Metopirone
Administration route: Oral
End date: 2011-10-21
Metopirone
Administration route: Oral
Start date: 2011-01-10
Metopirone
Administration route: Oral
Start date: 2012-01-01
Metopirone
Administration route: Oral
Start date: 2011-07-01
Nizoral
Administration route: Oral
End date: 2011-10-21
Nizoral
Administration route: Oral
Start date: 2010-12-01
Nizoral
Administration route: Oral
Start date: 2010-04-01
Nizoral
Administration route: Oral
Start date: 2011-12-26
Nizoral
Administration route: Oral
Indication: Hypercorticoidism
Nizoral
Administration route: Oral
Start date: 2012-01-01
Nizoral
Administration route: Oral
Start date: 2012-01-01
Nizoral
Dosage: morning and evening
Administration route: Oral
End date: 2011-02-01
Nizoral
Administration route: Oral
Start date: 2011-06-01
Nizoral
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Levothyroxine Sodium; Vitamin D; Tamoxifen Citrate; Ezetimibe; Protelos; Aldactone; Crestor
Possible Nizoral side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-27
Patient: female
Reactions: Off Label Use, Myoclonus, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metopirone
Administration route: Oral
Start date: 2011-03-28
Metopirone
Administration route: Oral
Start date: 2011-01-01
Metopirone
Administration route: Oral
Start date: 2011-01-10
Metopirone
Administration route: Oral
Indication: Hypercorticoidism
Metopirone
Administration route: Oral
Start date: 2011-01-06
Metopirone
Administration route: Oral
Start date: 2011-07-01
Metopirone
Administration route: Oral
End date: 2011-10-21
Metopirone
Dosage: 2 tablets in morning, 1 tablet at mid day, 1 tablet at the evening and 2 tablets at bed time.
Administration route: Oral
Start date: 2012-01-01
Metopirone
Administration route: Oral
Start date: 2012-01-01
Nizoral
Administration route: Oral
Start date: 2011-12-26
Nizoral
Administration route: Oral
Start date: 2012-01-01
Nizoral
Administration route: Oral
Start date: 2010-04-01
Nizoral
Administration route: Oral
Start date: 2011-06-01
Nizoral
Administration route: Oral
End date: 2011-10-21
Nizoral
Administration route: Oral
Indication: Hypercorticoidism
Nizoral
Dosage: morning and evening
Administration route: Oral
End date: 2011-02-01
Nizoral
Administration route: Oral
Start date: 2012-01-01
Nizoral
Administration route: Oral
Start date: 2012-01-01
Nizoral
Administration route: Oral
Start date: 2010-12-01
Other drugs received by patient: Aldactone; Tamoxifen Citrate; Ezetimibe; Crestor; Vitamin D; Levothyroxine Sodium; Protelos
Possible Nizoral side effects in female
Reported by a consumer/non-health professional from Australia on 2012-02-27
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Myalgia, Breast Pain, Pain in Extremity, Duodenal Ulcer, Paraesthesia
Drug(s) suspected as cause:
Nizoral
Other drugs received by patient: Trusopt; Noten
Possible Nizoral side effects in female
Reported by a physician from Denmark on 2012-02-22
Patient: female
Reactions: Hepatic Function Abnormal, Fatigue, Nausea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in female
Reported by a consumer/non-health professional from Australia on 2012-02-22
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Breast Pain, Myalgia, Pain in Extremity, Duodenal Ulcer, Paraesthesia
Drug(s) suspected as cause:
Nizoral
Other drugs received by patient: Noten; Trusopt
Possible Nizoral side effects in female
Reported by a consumer/non-health professional from Australia on 2012-02-21
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Breast Pain, Myalgia, Pain in Extremity, Duodenal Ulcer, Paraesthesia
Drug(s) suspected as cause:
Nizoral
Other drugs received by patient: Trusopt; Noten
Possible Nizoral side effects in 57 year old male
Reported by a consumer/non-health professional from China on 2012-02-21
Patient: 57 year old male
Reactions: Pruritus, Penile Oedema
Drug(s) suspected as cause:
AN Unknown Medication
Administration route: Oral
Indication: Tinea Versicolour
Start date: 2012-02-01
Nizoral
Administration route: Oral
Indication: Tinea Versicolour
Start date: 2012-02-05
End date: 2012-02-07
Possible Nizoral side effects in female
Reported by a physician from Denmark on 2012-02-21
Patient: female
Reactions: Hepatic Function Abnormal, Fatigue, Nausea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in 57 year old male
Reported by a consumer/non-health professional from China on 2012-02-14
Patient: 57 year old male
Reactions: Pruritus, Penile Oedema
Drug(s) suspected as cause:
AN Unknown Medication
Administration route: Oral
Indication: Tinea Versicolour
Start date: 2012-02-01
Nizoral
Administration route: Oral
Indication: Tinea Versicolour
Start date: 2012-02-05
End date: 2012-02-07
Possible Nizoral side effects in 80 year old male
Reported by a physician from France on 2012-02-13
Patient: 80 year old male
Reactions: Electrocardiogram QT Prolonged, Ventricular Arrhythmia
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in female
Reported by a physician from Denmark on 2012-02-13
Patient: female
Reactions: Hepatic Function Abnormal, Fatigue, Nausea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Possible Nizoral side effects in 41 year old female
Reported by a consumer/non-health professional from United States on 2012-01-30
Patient: 41 year old female
Reactions: Cellulitis, Drug Ineffective
Drug(s) suspected as cause:
Armodafinil
Indication: Product Used FOR Unknown Indication
Nizoral
Indication: Product Used FOR Unknown Indication
Possible Nizoral side effects in 41 year old female
Reported by a consumer/non-health professional from United States on 2012-01-25
Patient: 41 year old female
Reactions: Cellulitis, Limb Discomfort, Pain in Extremity, Drug Ineffective, Oedema Peripheral, Gait Disturbance, Erythema
Drug(s) suspected as cause:
Armodafinil
Dosage: unk
Nizoral
Dosage: unk
Possible Nizoral side effects in 41 year old female
Reported by a consumer/non-health professional from United States on 2012-01-24
Patient: 41 year old female
Reactions: Cellulitis, Drug Ineffective
Drug(s) suspected as cause:
Armodafinil
Indication: Product Used FOR Unknown Indication
Nizoral
Indication: Product Used FOR Unknown Indication
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