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Nizoral (Ketoconazole) - Side Effect Reports to FDA

 
 



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)Death (3)Myalgia (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 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

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 2012-07-02

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 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 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 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 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 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 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 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 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 2012-02-14

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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