Nitazoxanide

Nitazoxanide is a prescription medication used to treat Diarrhea caused by Cryptosporidium Parvum or Giardia Lamblia. 

• Nitazoxanide is available under the following different brand names: Alinia

Adult and pediatric dosage

Tablet

• 500mg

Oral suspension

• 100mg/5mL

Diarrhea caused by Cryptosporidium Parvum or Giardia Lamblia

Adult dosage

• 500 mg orally every 12 hours for 3 days

Pediatric dosage

• Children younger than 1 year of age: Safety and efficacy not established
• Children 1-3 years of age: 5 mL (100 mg) orally every 12 hours for 3 days
• Children 4-11 years of age: 10 mL (200 mg) orally every 12 hours for 3 days
• Children 12 years of age or older: 500 mg orally every 12 hours for 3 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Nitazoxanide include:

• nausea, 
• stomach pain, 
• headache, and 
• discolored urine

Serious side effects of Nitazoxanide include:

• hives, 
• difficulty breathing, and
• swelling of the face, lips, tongue, or throat

Rare side effects of Nitazoxanide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Nitazoxanide has severe interactions with no other drugs.
• Nitazoxanide has serious interactions with the following drugs:
  • baricitinib
  • phenytoin
  • valproic acid
  • warfarin
• Nitazoxanide has moderate interactions with at least 11 other drugs.
• Nitazoxanide has minor interactions with at least 14 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nitazoxanide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nitazoxanide?”

Cautions

• Safety and efficacy not established in HIV+ or immunodeficient patients
• Effects in hepatic/renal impairment unknown; use caution
• Safety and efficacy of suspension in children younger than 1 year not established
• Safety and efficacy of tablets in children younger than 12 years not established

Drug interaction overview

• Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (over 99.9%)
• Monitor for adverse reactions if nitazoxanide is coadministered with other highly protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin)
• The prescribing information recommends avoiding concurrent warfarin use

Pregnancy and Lactation

• No data with pregnant women to inform of drug-associated risk; No teratogenicity or fetotoxicity observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA)
• Development and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed infant from therapy or from the underlying maternal condition.