NITAZOXANIDE: 457 Adverse Event Reports & Safety Profile
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Drug Class: Antiprotozoal [EPC] · Route: ORAL · Manufacturer: Rising Pharma Holdings, Inc. · FDA Application: 021497 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 2010 · Latest Report: 20250309
What Are the Most Common NITAZOXANIDE Side Effects?
All NITAZOXANIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 104 | 22.8% | 3 | 7 |
| Chromaturia | 57 | 12.5% | 0 | 1 |
| Nausea | 49 | 10.7% | 0 | 3 |
| Abdominal pain upper | 43 | 9.4% | 0 | 1 |
| Disease progression | 41 | 9.0% | 9 | 0 |
| Dyspnoea | 37 | 8.1% | 1 | 2 |
| Chest pain | 36 | 7.9% | 0 | 1 |
| Drug ineffective | 36 | 7.9% | 12 | 7 |
| Therapeutic product effect incomplete | 32 | 7.0% | 0 | 0 |
| Coma scale abnormal | 31 | 6.8% | 0 | 0 |
| Microsporidia infection | 31 | 6.8% | 0 | 0 |
| Pneumocystis jirovecii infection | 31 | 6.8% | 0 | 0 |
| Abdominal pain | 30 | 6.6% | 0 | 1 |
| Headache | 29 | 6.4% | 0 | 3 |
| Off label use | 25 | 5.5% | 3 | 11 |
| Dizziness | 23 | 5.0% | 0 | 1 |
| Abdominal discomfort | 20 | 4.4% | 0 | 0 |
| Fatigue | 18 | 3.9% | 0 | 1 |
| Treatment failure | 17 | 3.7% | 6 | 4 |
| Vomiting | 15 | 3.3% | 0 | 2 |
Who Reports NITAZOXANIDE Side Effects? Age & Gender Data
Gender: 57.9% female, 42.1% male. Average age: 47.6 years. Most reports from: US. View detailed demographics →
Is NITAZOXANIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 1 |
| 2015 | 10 | 0 | 1 |
| 2016 | 30 | 0 | 1 |
| 2017 | 56 | 0 | 1 |
| 2018 | 76 | 0 | 2 |
| 2019 | 62 | 0 | 0 |
| 2020 | 68 | 0 | 4 |
| 2021 | 11 | 0 | 0 |
| 2022 | 2 | 0 | 0 |
| 2023 | 4 | 0 | 1 |
| 2024 | 2 | 0 | 1 |
| 2025 | 6 | 0 | 3 |
What Is NITAZOXANIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 150 |
| Cryptosporidiosis infection | 29 |
| Diarrhoea | 21 |
| Helicobacter infection | 19 |
| Lyme disease | 18 |
| Gastrointestinal bacterial overgrowth | 16 |
| Infection parasitic | 14 |
| Giardiasis | 13 |
| Irritable bowel syndrome | 12 |
| Microsporidia infection | 10 |
NITAZOXANIDE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Antiprotozoal [EPC]
Official FDA Label for NITAZOXANIDE
Official prescribing information from the FDA-approved drug label.
Drug Description
Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy- N -(5-nitro-2-thiazolyl) benzamide. The molecular formula is C 12 H 9 N 3 O 5 S and the molecular weight is 307.3. The structural formula is: Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake. nitazoxanide-structure.jpg
FDA Approved Uses (Indications)
AND USAGE Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ] . Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1 ). Limitations of Use: Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients (1).
Dosage & Administration
AND ADMINISTRATION
- Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger (2.1).
- Dosage for treatment of diarrhea caused by G. lamblia or C. parvum (2.1) : Age Dosage Duration 12 years and older One nitazoxanide tablet (500 mg nitazoxanide) every 12 hours with food 3 days
2.1 Recommended Dosage and Important Administration Instructions Important Administration Instructions for Pediatric Patients 11 years of Age or Younger: Nitazoxanide tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group.
Table
1.
Recommended Dosage Age Dosage Duration
12 years and older One Nitazoxanide tablet (500 mg nitazoxanide) taken orally every 12 hours with food 3 days
Contraindications
Hypersensitivity (4.1)
4.1 Hypersensitivity Nitazoxanide tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
Known Adverse Reactions
REACTIONS The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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 safety of nitazoxanide was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received nitazoxanide tablets or nitazoxanide for oral suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with nitazoxanide tablets or nitazoxanide for oral suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%). Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving nitazoxanide at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for nitazoxanide-treated subjects based upon age.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of nitazoxanide. 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 is a list of adverse reactions spontaneously reported with nitazoxanide tablets which were not included in clinical trial listings: Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease Nervous System disorders: dizziness Respiratory, thoracic and mediastinal disorders: dyspnea Skin and subcutaneous tissue disorders: rash, urticaria
Drug Interactions
INTERACTIONS Competition for binding sites may occur when administered concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices. Monitor for adverse reactions ( 7 ).