DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ketoconazole (Ketoconazole Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ketoconazole (Ketoconazole Topical) 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 (107)
Death (1)
Life Threatening Events (6)
Disability (5)

Reports by Reaction Type

Drug Interaction (19)Off Label Use (15)Rhabdomyolysis (12)Prostatic Specific Antigen Increased (12)Pruritus (10)Renal Failure Acute (10)Rash (9)Asthenia (9)Neurotoxicity (8)Fatigue (8)Hepatotoxicity (8)Dizziness (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Ketoconazole (Ketoconazole Topical). For a complete list or a specific selection of reports, please use the links above.

Possible Ketoconazole side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Psychomotor Hyperactivity, Vomiting, Drug Effect Decreased, Body Mass Index Increased, Drug Interaction, Orthostatic Hypotension, Abnormal Behaviour, Condition Aggravated, Mucosal Dryness, Constipation, Menstrual Disorder, Diplopia, Oedema, Dizziness

Drug(s) suspected as cause:
Clarithromycin
    Indication: Respiratory Tract Infection

Gabapentin
    Indication: Post-Traumatic Epilepsy

Ketoconazole
    Dosage: 7 days
    Indication: Vaginal Lesion

Lamotrigine
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Bromocriptine Mesylate
    Dosage: 7.5 mg/day
    Indication: Prolactinoma

Bromocriptine Mesylate
    Dosage: 15 mg

Bromocriptine Mesylate
    Dosage: 20 mg

Cabergoline
    Dosage: 0.25 mg, 2/week
    Indication: Prolactinoma

Cabergoline
    Dosage: 2 mg/ week

Oxcarbazepine
    Dosage: 1200 mg/day

Oxcarbazepine
    Dosage: 600 mg
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient: Quinagolide



Possible Ketoconazole side effects in 83 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-15

Patient: 83 year old female

Reactions: Potentiating Drug Interaction, Hypotension, Atrioventricular Block Complete, Mental Status Changes, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Oral
    Indication: Cushing's Syndrome

Ketoconazole
    Administration route: Oral

Verapamil
    Indication: Hypertension

Other drugs received by patient: Potassium



Possible Ketoconazole side effects in male

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-01

Patient: male

Reactions: Off Label Use, Prostatic Specific Antigen Decreased

Drug(s) suspected as cause:
Ketoconazole

Other drugs received by patient: Prednisolone



Possible Ketoconazole side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: male

Reactions: Adverse Event, Multiple Allergies, HIP Surgery

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: 83 year old female

Reactions: Drug Level Increased, Atrioventricular Block Complete, Hypotension, Mental Status Changes, Muscular Weakness, Cushing's Syndrome, Hypokalaemia, Alkalosis Hypochloraemic, Hypertension

Drug(s) suspected as cause:
Ketoconazole
    Dosage: 300 mg/four times per day/oral
    Administration route: Oral

Verapamil
    Indication: Hypertension

Other drugs received by patient: Potassium Salt



Possible Ketoconazole side effects in 42 year old male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 42 year old male, weighing 97.5 kg (214.6 pounds)

Reactions: Burning Sensation, Urticaria, Rash

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 22 year old female

Reported by a individual with unspecified qualification from France on 2012-07-24

Patient: 22 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Mydriasis, Intentional Overdose, Hypothermia, Hypoglycaemia, Coagulopathy, Hepatic Failure, Lactic Acidosis, Drug Abuse, Loss of Consciousness, Renal Failure, Drug Dependence, Cardiac Arrest, Cardiac Failure Congestive, Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ketoconazole
    Indication: Vaginal Infection

Tramadol Hydrochloride

Tramadol Hydrochloride
    Indication: Dysmenorrhoea



Possible Ketoconazole side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12

Patient: 83 year old female

Reactions: Off Label Use, Atrioventricular Block, Mental Status Changes, Drug Interaction

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Oral
    Indication: Cushing's Syndrome

Ketoconazole
    Dosage: for 2 days
    Administration route: Oral

Potassium Chloride
    Administration route: Oral
    Indication: Hypokalaemia

Other drugs received by patient possibly interacting with the suspect drug:
Verapamil
    Indication: Hypertension



Possible Ketoconazole side effects in female

Reported by a pharmacist from France on 2012-07-11

Patient: female

Reactions: Pruritus Generalised, Accidental Exposure

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 58 year old female

Reported by a consumer/non-health professional from Mexico on 2012-07-09

Patient: 58 year old female, weighing 85.0 kg (187.0 pounds)

Reactions: Pruritus, Skin Exfoliation, Dandruff, Skin Ulcer, Dermatitis, Fungal Infection, Pigmentation Disorder, Blister

Drug(s) suspected as cause:
Ketoconazole
    Dosage: unk
    Indication: Dandruff

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2012-03-01

Other drugs received by patient: Omeprazole (Prisolec); Clonazepam; Clonazepam; Cisapride; Rhodiola Rosea; Dulcolax



Possible Ketoconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Amoxapine
    Indication: Product Used FOR Unknown Indication

AN Unknown Medication
    Indication: Product Used FOR Unknown Indication

Augmentin '125'
    Indication: Product Used FOR Unknown Indication

Benadryl
    Indication: Product Used FOR Unknown Indication

Betamethasone
    Indication: Product Used FOR Unknown Indication

Biaxin XL
    Indication: Product Used FOR Unknown Indication

Ceftin
    Indication: Product Used FOR Unknown Indication

Ciprofloxacin HCL
    Indication: Product Used FOR Unknown Indication

Claritin
    Indication: Product Used FOR Unknown Indication

Cleocin Hydrochloride
    Indication: Product Used FOR Unknown Indication

Clindamycin
    Indication: Product Used FOR Unknown Indication

Codeine Sulfate
    Indication: Product Used FOR Unknown Indication

Darvocet
    Indication: Product Used FOR Unknown Indication

Darvon
    Indication: Product Used FOR Unknown Indication

Demadex
    Indication: Product Used FOR Unknown Indication

Demerol
    Indication: Product Used FOR Unknown Indication

Erythromycin
    Indication: Product Used FOR Unknown Indication

Flexeril
    Indication: Product Used FOR Unknown Indication

Floxin
    Indication: Product Used FOR Unknown Indication

Fosamax
    Indication: Product Used FOR Unknown Indication

Gantrisin
    Indication: Product Used FOR Unknown Indication

Gentamicin
    Indication: Product Used FOR Unknown Indication

Geocillin
    Indication: Product Used FOR Unknown Indication

Hismanal
    Indication: Product Used FOR Unknown Indication

Intravenous Pyelogram DYE
    Indication: Product Used FOR Unknown Indication

Keflex
    Indication: Product Used FOR Unknown Indication

Ketoconazole
    Indication: Product Used FOR Unknown Indication

Ketoprofen
    Indication: Product Used FOR Unknown Indication

Konsyl
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication

Levsinex
    Indication: Product Used FOR Unknown Indication

Lopid
    Indication: Product Used FOR Unknown Indication

Macrobid
    Indication: Product Used FOR Unknown Indication

Macrodantin
    Indication: Product Used FOR Unknown Indication

Mandelamine
    Indication: Product Used FOR Unknown Indication

Maxaquin
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Indication: Product Used FOR Unknown Indication

Monistat

Monistat
    Indication: Product Used FOR Unknown Indication

Negram Powder
    Indication: Product Used FOR Unknown Indication

Nilstat
    Indication: Product Used FOR Unknown Indication

Noroxin
    Indication: Product Used FOR Unknown Indication

Norpramin
    Indication: Product Used FOR Unknown Indication

Omniflox
    Indication: Product Used FOR Unknown Indication

Orphenadrine Citrate
    Indication: Product Used FOR Unknown Indication

Pentazocine Lactate
    Indication: Product Used FOR Unknown Indication

Persantine
    Indication: Product Used FOR Unknown Indication

Premarin
    Indication: Product Used FOR Unknown Indication

Propantheline Bromide
    Indication: Product Used FOR Unknown Indication

Quinolone
    Indication: Product Used FOR Unknown Indication

Sinequan
    Indication: Product Used FOR Unknown Indication

SLO-BID
    Indication: Product Used FOR Unknown Indication

Sulfur
    Indication: Product Used FOR Unknown Indication

Suprax
    Indication: Product Used FOR Unknown Indication

TAO
    Indication: Product Used FOR Unknown Indication

Tavist-D
    Indication: Product Used FOR Unknown Indication

Tetracycline
    Indication: Product Used FOR Unknown Indication

Theo-DUR
    Indication: Product Used FOR Unknown Indication

Trimpex
    Indication: Product Used FOR Unknown Indication

Urised
    Indication: Product Used FOR Unknown Indication

Valium
    Indication: Product Used FOR Unknown Indication



Possible Ketoconazole side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-28

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Bilastine
    Dosage: at therapeutic and supratherapeutic doses (20 mg and 100 mg) or bilastine 20 mg with ketoconazole
    Indication: Product Used FOR Unknown Indication

Ketoconazole
    Indication: Product Used FOR Unknown Indication



Possible Ketoconazole side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-27

Patient: 77 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Cholelithiasis, Rhabdomyolysis, Oral Candidiasis, Drug Interaction, Hypothyroidism, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2011-11-01

Zocor
    Administration route: Oral
    Indication: Coronary Artery Disease
    End date: 2011-11-01



Possible Ketoconazole side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22

Patient: 44 year old male

Reactions: Blood Calcium Decreased, Drug Interaction

Drug(s) suspected as cause:
Ketoconazole
    Dosage: administered in the evening of day -1 and day 2-3
    Indication: Product Used FOR Unknown Indication

Placebo
    Dosage: on day 1 of each period
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient possibly interacting with the suspect drug:
Bosutinib
    Dosage: on day 1 of each period
    Indication: Product Used FOR Unknown Indication



Possible Ketoconazole side effects in 33 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22

Patient: 33 year old male

Reactions: Drug Interaction, Neutrophil Count Decreased

Drug(s) suspected as cause:
Ketoconazole
    Dosage: administered in the evening of day -1 and day 2-3
    Indication: Product Used FOR Unknown Indication

Placebo
    Dosage: on day 1 of each period
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient possibly interacting with the suspect drug:
Bosutinib
    Dosage: on day 1 of each period
    Indication: Product Used FOR Unknown Indication



Possible Ketoconazole side effects in 88 year old male

Reported by a pharmacist from United States on 2012-06-18

Patient: 88 year old male

Reactions: Rash Macular

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: male, weighing 70.3 kg (154.7 pounds)

Reactions: Weight Increased, Blood Alkaline Phosphatase Increased, Prostatic Specific Antigen Increased, Drug Ineffective, Fluid Retention

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2007-01-01
    End date: 2011-01-01

Zytiga
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2011-06-04
    End date: 2011-09-09

Other drugs received by patient: Avodart; Ursodiol; Lexapro; Crestor



Possible Ketoconazole side effects in 91 year old female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 91 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Rash, Skin Irritation

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 50 year old male

Reported by a physician from United States on 2012-06-04

Patient: 50 year old male

Reactions: Off Label Use, Hyperkalaemia, Adrenocortical Insufficiency Acute, Hypoglycaemia, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole
    Dosage: 200 mg;
    Indication: Hypercorticoidism

Ketoconazole
    Dosage: 200 mg;
    Indication: Off Label Use



Possible Ketoconazole side effects in 34 year old female

Reported by a consumer/non-health professional from China on 2012-05-29

Patient: 34 year old female

Reactions: Product Counterfeit, Application Site Swelling, Application Site Pain, Application Site Vesicles

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-29

Patient:

Reactions: Adverse Event

Drug(s) suspected as cause:
Dihydroergotamine Mesylate
    Dosage: map0004; on day 2 and 6; 2 actuations; emitted dose of 0.63 mg
    Indication: Product Used FOR Unknown Indication

Ketoconazole
    Dosage: day 3 to day 6 (8.30 am)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Ketoconazole side effects in female

Reported by a pharmacist from China on 2012-05-21

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Jaundice, Fatigue, Hepatocellular Injury, Abdominal Distension, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 12 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-05-17

Patient: 12 year old female

Reactions: Drug Ineffective, Intracranial Pressure Increased, Sinusitis, Papilloedema

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-16

Patient: 19 year old female

Reactions: Chapped Lips, Drug Hypersensitivity, Eczema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-15

Patient: 38 year old male

Reactions: Eczema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-05-15

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Ketoconazole
    Indication: Pituitary-Dependent Cushing's Syndrome

Radiation Therapy NOS
    Indication: Pituitary-Dependent Cushing's Syndrome



Possible Ketoconazole side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-09

Patient: 19 year old female

Reactions: Chapped Lips, Eczema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-07

Patient: 38 year old male

Reactions: Eczema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-04

Patient: 38 year old male

Reactions: Off Label Use, Eczema, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole

Other drugs received by patient: Herbal OIL NOS



Possible Ketoconazole side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: male

Reactions: Off Label Use, Thrombocytopenia

Drug(s) suspected as cause:
Ketoconazole

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014