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Nizoral

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Nizoral

Nizoral Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Nizoral (ketoconazole) is a medication indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Some common side effects associated with Nizoral may include: mild nausea, vomiting, or stomach pain; mild itching or skin rash; headache; dizziness; breast swelling; or impotence or loss of interest in sex. Tell the doctor immediately if you notice and of these side effects. This is not a complete list of side effects, and others may occur.

Nizoral is administered orally in the form of tablets. Drug interactions of Nizoral may include reactions with antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others). Avoid taking these drugs for at least 2 hours after you have taken your dose of ketoconazole.You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion). Safe use of Nizoral during pregnancy and lactation has not been established; therefore, the potential benefits must be weighed against the possible hazards.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nizoral in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • dizziness, fainting, fast or pounding heartbeat;
  • easy bruising or bleeding, unusual weakness;
  • numbness or tingly feeling;
  • severe depression, confusion, or thoughts of hurting yourself; or
  • nausea, stomach pain, low fever, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

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

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nizoral Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: headache, vision changes, mental/mood changes (such as depression, thoughts of suicide).

Although unlikely, when ketoconazole is used at high doses, it may cause an adrenal gland problem (adrenal insufficiency), a decrease in testosterone levels, and a decrease in sperm production. Ketoconazole can also worsen existing adrenal gland function problems (See also Precautions section). The adrenal gland problem may make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication. Your doctor may order a blood test to monitor your adrenal gland function while you are taking ketoconazole. These effects usually go away after ketoconazole treatment is stopped. Tell your doctor right away if you have any serious side effects, including: unusual tiredness, weakness, dizziness upon standing, diarrhea, weight loss, menstrual period changes, decreased sexual interest or ability, enlarged/tender breasts in men.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nizoral (Ketoconazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nizoral FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 - User Reviews

Nizoral User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nizoral sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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