What the label lists and what reports show
Nitazoxanide side effects
Nitazoxanide's FDA label: “The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1).” FAERS holds 343 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (68 reports).
- Generic listed
Check it at the source: the nitazoxanide FDA label on DailyMed (effective October 9, 2025, Rising Pharma Holdings, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1).
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, Rising Pharma Holdings, Inc., effective October 9, 2025 (SPL set c0dc0656-3c46-43f9-adea-5285c522cef8), via openFDA; the full label on DailyMed
What do FAERS reports show?
343 reports list nitazoxanide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 71 are coded as a death and 139 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nitazoxanide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions