Nizoral
A Polio-Free U.S. Thanks to Vaccine Efforts »
"It is crucial to maintain the success rate of U.S. vaccination efforts since the disease still exists in some parts of the world. People most at risk are those who never had polio vaccine, those who never received all the recommended vaccine dose"...
Read the A Polio-Free U.S. Thanks to Vaccine Efforts article »
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
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 immediately if any of these rare but serious side effects occur: 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. These effects usually go away after ketoconazole treatment is stopped. Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, weakness, dizziness upon standing, persistent nausea/vomiting, diarrhea, stomach pain, loss of appetite, weight loss, decreased sexual interest or ability, enlarged/tender breasts in men.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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
In rare cases, anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported. However, the most frequent adverse reactions were nausea and/or vomiting in approximately 3%, abdominal pain in 1.2%, pruritus in 1.5%, and the following in less than 1% of the patients: headache, dizziness, somnolence, fever and chills, photophobia, diarrhea, gynecomastia, impotence, thrombocytopenia, leukopenia, hemolytic anemia, and bulging fontanelles. Oligospermia has been reported in investigational studies with the drug at dosages above those currently approved. Oligospermia has not been reported at dosages up to 400 mg daily, however sperm counts have been obtained infrequently in patients treated with these dosages. Most of these reactions were mild and transient and rarely required discontinuation of NIZORAL® (ketoconazole) Tablets. In contrast, the rare occurrences of hepatic dysfunction require special attention (see WARNINGS section).
In worldwide postmarketing experience with NIZORAL® (ketoconazole) Tablets there have been rare reports of alopecia, paresthesia, and signs of increased intracranial pressure including bulging fontanelles and papilledema. Hypertriglyceridemia has also been reported but a causal association with NIZORAL® (ketoconazole) Tablets is uncertain.
Neuropsychiatric disturbances, including suicidal tendencies and severe depression, have occurred rarely in patients using NIZORAL® (ketoconazole) Tablets.
Ventricular dysrhythmias (prolonged QT intervals) have occurred with the concomitant use of terfenadine with ketoconazole tablets. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.) Data suggest that coadministration of ketoconazole tablets and cisaspride can result in prolongation of the QT interval and has rarely been associated with ventricular arrhythmias. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)
Read the entire FDA prescribing information for Nizoral (Ketoconazole) »
Additional Nizoral Information
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.
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.
Women's Health
Find out what women really need.
Updated & New
