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NIZORAL

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Nizoral Adverse Events Reported to the FDA Over Time

How are Nizoral adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Nizoral, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Nizoral is flagged as the suspect drug causing the adverse event.

Most Common Nizoral Adverse Events Reported to the FDA

What are the most common Nizoral adverse events reported to the FDA?

Off Label Use
45 (3.35%)
Overdose
39 (2.9%)
Drug Exposure During Pregnancy
38 (2.83%)
Alopecia
27 (2.01%)
Abortion Spontaneous
23 (1.71%)
Hepatitis
21 (1.56%)
Erythema
19 (1.41%)
Pruritus
18 (1.34%)
Dizziness
17 (1.26%)
Nausea
16 (1.19%)
Asthenia
15 (1.12%)
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Drug Ineffective
15 (1.12%)
Intentional Drug Misuse
15 (1.12%)
Abdominal Pain Upper
14 (1.04%)
Fatigue
14 (1.04%)
Jaundice
14 (1.04%)
Pyrexia
14 (1.04%)
Diarrhoea
13 (.97%)
Death
12 (.89%)
Disseminated Intravascular Coagulat...
11 (.82%)
Burning Sensation
10 (.74%)
Ear Discomfort
10 (.74%)
Hypoacusis
10 (.74%)
Product Quality Issue
10 (.74%)
Rash
10 (.74%)
Vomiting
10 (.74%)
Cholestasis
9 (.67%)
Drug Interaction
9 (.67%)
Dyspnoea
9 (.67%)
Gamma-glutamyltransferase Increased
9 (.67%)
Headache
9 (.67%)
Hepatic Encephalopathy
9 (.67%)
Insomnia
9 (.67%)
Pain
9 (.67%)
Pain In Extremity
9 (.67%)
Product Counterfeit
9 (.67%)
Subacute Hepatic Failure
9 (.67%)
Alanine Aminotransferase Increased
8 (.6%)
Aspartate Aminotransferase Increase...
8 (.6%)
Drug Ineffective For Unapproved Ind...
8 (.6%)
Hepatic Function Abnormal
8 (.6%)
Paraesthesia
8 (.6%)
Seborrhoeic Dermatitis
8 (.6%)
Transaminases Increased
8 (.6%)
Tremor
8 (.6%)
Trichorrhexis
8 (.6%)
Wrong Technique In Drug Usage Proce...
8 (.6%)
Back Pain
7 (.52%)
Gastritis
7 (.52%)
Hospitalisation
7 (.52%)
Application Site Discolouration
6 (.45%)
Cholecystitis
6 (.45%)
Hepatic Failure
6 (.45%)
Oedema Peripheral
6 (.45%)
Swelling Face
6 (.45%)
Thrombocytopenia
6 (.45%)
Urticaria
6 (.45%)
Visual Acuity Reduced
6 (.45%)
Anaemia
5 (.37%)
Arrhythmia
5 (.37%)
Blister
5 (.37%)
Blood Alkaline Phosphatase Abnormal
5 (.37%)
Chromaturia
5 (.37%)
Convulsion
5 (.37%)
Drug Toxicity
5 (.37%)
Generalised Erythema
5 (.37%)
Inappropriate Schedule Of Drug Admi...
5 (.37%)
Lung Neoplasm Malignant
5 (.37%)
Myoclonus
5 (.37%)
Rhabdomyolysis
5 (.37%)
Skin Exfoliation
5 (.37%)
Stevens-johnson Syndrome
5 (.37%)
Abdominal Distension
4 (.3%)
Application Site Discharge
4 (.3%)
Auricular Swelling
4 (.3%)
Blood Alkaline Phosphatase Increase...
4 (.3%)
Blood Pressure Increased
4 (.3%)
Breast Pain
4 (.3%)
Cerebrovascular Accident
4 (.3%)
Chest Pain
4 (.3%)
Diabetes Mellitus
4 (.3%)
Dry Eye
4 (.3%)
Dry Mouth
4 (.3%)
Erythema Nodosum
4 (.3%)
Eye Swelling
4 (.3%)
Febrile Neutropenia
4 (.3%)
Generalised Oedema
4 (.3%)
International Normalised Ratio Incr...
4 (.3%)
Liver Function Test Abnormal
4 (.3%)
Liver Injury
4 (.3%)
Loss Of Consciousness
4 (.3%)
Metastases To Bone
4 (.3%)
Myalgia
4 (.3%)
Neutropenia
4 (.3%)
Pancytopenia
4 (.3%)
Priapism
4 (.3%)
Renal Failure Acute
4 (.3%)
Sexual Dysfunction
4 (.3%)
Shock
4 (.3%)
Syncope
4 (.3%)
Therapeutic Response Decreased
4 (.3%)

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This graph shows the top adverse events submitted to the FDA for Nizoral, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Nizoral is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Nizoral

What are the most common Nizoral adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Nizoral, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Nizoral is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Nizoral According to Those Reporting Adverse Events

Why are people taking Nizoral, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
75
Product Used For Unknown Indication
40
Onychomycosis
39
Fungal Infection
35
Prostate Cancer
22
Seborrhoeic Dermatitis
20
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Dandruff
18
Tinea Infection
17
Tinea Pedis
15
Acne
15
Cushings Syndrome
13
Candidiasis
13
Vulvovaginal Candidiasis
11
Rash
11
Fungal Skin Infection
11
Tinea Versicolour
11
Drug Exposure During Pregnancy
8
Seborrhoea
7
Folliculitis
6
Antifungal Prophylaxis
6
Dermatitis
5
Psoriasis
5
Hypercorticoidism
4
Vulvovaginal Mycotic Infection
4
Hyperadrenocorticism
4
Hiv Infection
4
Neoplasm Malignant
4
Prophylaxis
4
Pituitary-dependent Cushings Syndro...
3
Coccidioidomycosis
3
Skin Disorder
3
Candida Nappy Rash
3
Dermatophytosis
3
Oesophageal Candidiasis
3
Infection
3
Dry Skin
2
Keratitis Fungal
2
Vaginal Infection
2
Testotoxicosis
2
Pituitary Tumour
2
Dermatitis Bullous
2
Infection Prophylaxis
2
Blood Cortisol Increased
2
Body Tinea
2
Skin Infection
2
Alopecia
2
Adrenal Suppression
2
Prostate Cancer Metastatic
2
Oral Candidiasis
2
Eczema
2
Pruritus
2

Drug Labels

LabelLabelerEffective
Nizoral A-dMcNeil Consumer Healthcare Div. McNeil-PPC, Inc22-NOV-10
NizoralJanssen Pharmaceuticals, Inc.21-MAR-13

Nizoral Case Reports

What Nizoral safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Nizoral. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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