Ketoconzole adverse reactions

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Ketoconzole
Ketoconazole® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following adverse reactions were reported in clinical trials:

Immune System Disorders: anaphylactoid reaction

Endocrine Disorders: gynecomastia

Metabolism and Nutrition Disorders: alcohol intolerance, anorexia, hyperlipidemia, increased appetite

Psychiatric Disorders: insomnia, nervousness

Nervous System Disorders: headache, dizziness, paresthesia, somnolence

Eye Disorders: photophobia

Vascular Disorders: orthostatic hypotension

Respiratory, Thoracic and Mediastinal Disorders: epistaxis

Gastrointestinal Disorders: vomiting, diarrhea nausea, constipation, abdominal pain, abdominal pain upper, dry mouth, dysgeusia, dyspepsia, flatulence, tongue discoloration

Hepatobiliary Disorders: hepatitis, jaundice, hepatic function abnormal

Skin and Subcutaneous Tissues Disorders: erythema multiforme, rash, dermatitis, erythema, urticaria, pruritus, alopecia, xeroderma

Musculoskeletal and Connective Tissue Disorders: myalgia

Reproductive System and Breast Disorders: menstrual disorder

General Disorders and Administration Site Conditions: asthenia, fatigue, hot flush, malaise, edema peripheral, pyrexia, chills

Investigations: platelet count decreased.

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of ketoconazole tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Post-Marketing Experience

Blood and Lymphatic System Disorders: thrombocytopenia

Immune System Disorders: allergic conditions including anaphylactic shock, anaphylactic reaction, angioneurotic edema

Endocrine Disorders: adrenocortical insufficiency

Nervous System Disorders: reversible intracranial pressure increased (e.g. papilloedema, fontanelle bulging in infants)

Hepatobiliary Disorders: serious hepatotoxicity including hepatitis cholestatic, biopsyconfirmed hepatic necrosis, cirrhosis, hepatic failure including cases resulting in transplantation or death

Skin and Subcutaneous Tissue Disorders: acute generalized exanthematous pustulosis, photosensitivity

Musculoskeletal and Connective Tissue Disorders: arthralgia

Reproductive System and Breast Disorders: erectile dysfunction; with doses higher than the recommended therapeutic dose of 200 or 400mg daily, azoospermia.[1]

References

  1. "KETOCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]".

Adapted from the FDA Package Insert.