Nizoral

DRUG DESCRIPTION

NIZORAL® (ketoconazole) is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine and has the following structural formula:

 NIZORAL (ketoconazole) Structural Formula Illustration

Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44.

What are the possible side effects of ketoconazole (Nizoral)?

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,...

Read All Potential Side Effects and See Pictures of Nizoral »

What are the precautions when taking ketoconazole (Nizoral)?

Before taking ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal drugs (such as fluconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, alcohol use, low testosterone levels, decreased adrenal gland function problems (such as low cortisol levels, Addison's disease, adrenal insufficiency), little or no stomach acid production (achlorhydria).

Do not drink alcohol while taking this medication because alcohol increases the risk of serious liver problems. Avoiding...

Read All Potential Precautions of Nizoral »


Nizoral Consumer (continued)

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 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.

PRECAUTIONS: Before taking ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal drugs (such as fluconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, alcohol use, low testosterone levels, decreased adrenal gland function problems (such as low cortisol levels, Addison's disease, adrenal insufficiency), little or no stomach acid production (achlorhydria).

Do not drink alcohol while taking this medication because alcohol increases the risk of serious liver problems. Avoiding alcohol will also decrease the risk of a rare reaction with ketoconazole that may result in flushing, headache, and nausea.

During pregnancy, this medication should be used only when clearly needed. It may cause harm to an unborn baby if taken during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Nizoral Patient Information Including Side Effects

Brand Names: Nizoral

Generic Name: ketoconazole (Pronunciation: KEE toe KON a zole)

  • What is ketoconazole (Nizoral)?
  • What are the possible side effects of ketoconazole (Nizoral)?
  • What is the most important information I should know about ketoconazole (Nizoral)?
  • What should I discuss with my healthcare provider before taking ketoconazole (Nizoral)?
  • How should I take ketoconazole (Nizoral)?
  • What happens if I miss a dose (Nizoral)?
  • What happens if I overdose (Nizoral)?
  • What should I avoid while taking ketoconazole (Nizoral)?
  • What other drugs will affect ketoconazole (Nizoral)?
  • Where can I get more information?

What is ketoconazole (Nizoral)?

Ketoconazole is an antifungal antibiotic.

Ketoconazole is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, or skin.

Ketoconazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ketoconazole (Nizoral)?

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.

What is the most important information I should know about ketoconazole (Nizoral)?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion).

Before taking ketoconazole, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, decreased stomach acid (achlorhydria), or a history of "Long QT syndrome."

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ketoconazole will not treat a viral infection such as the common cold or flu.

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking ketoconazole.

Related Drug Centers
  • Nizoral


Related Drugs Index: