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Last reviewed on RxList: 2/13/2017
Nizoral Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/22/2016

Nizoral (ketoconazole) is an antifungal agent indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Common side effects of Nizoral include:

  • nausea,
  • vomiting,
  • stomach pain,
  • itching or skin rash,
  • headache,
  • dizziness,
  • breast swelling,
  • impotence, or
  • loss of interest in sex.

Tell your doctor if you have serious side effects of Nizoral including:

  • vision changes, or
  • mental/mood changes (such as depression, thoughts of suicide).

The recommended adult starting dose of Nizoral tablets is a single daily administration of 200 mg (one tablet). Nizoral may interact with acetaminophen, cyclosporine, clopidogrel, digoxin, tacrolimus, loratadine, methylprednisolone, phenytoin, rifampin, oral diabetes medications, sedatives, blood thinners, cancer medications, birth control pills or hormone replacement therapy, methotrexate, cholesterol medications, or medications to treat HIV or AIDS. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Nizoral; it is unknown if it will harm a fetus. Nizoral may pass into breast milk and could harm a nursing baby. Consult your doctor before breastfeeding.

Our Nizoral Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nizoral Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; fever; difficulty breathing, chest pain; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • unusual weakness or tired feeling, nausea and vomiting; or
  • liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Common side effects may include:

  • mild nausea or stomach pain;
  • diarrhea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nizoral (Ketoconazole)

Nizoral Professional Information


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 Nizoral 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.

The following adverse reactions were reported during 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, biopsy-confirmed 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.

Read the entire FDA prescribing information for Nizoral (Ketoconazole)

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© Nizoral Patient Information is supplied by Cerner Multum, Inc. and Nizoral Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.


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