Nitazoxanide Side Effects

Please note - some side effects for Nitazoxanide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nitazoxanide - for the Consumer

Nitazoxanide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nitazoxanide:

Diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; fainting; fast heartbeat; severe or persistent dizziness; shortness of breath; unusual tiredness.

Nitazoxanide Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nitazoxanide Suspension:

Diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; fainting; fast heartbeat; severe or persistent dizziness; shortness of breath; unusual tiredness.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (6.6% to 7.8%), diarrhea (2.1% to 4.2%), and nausea (3%). Side effects occurring in less than 1% of patients have included vomiting, anorexia, flatulence, dyspepsia, constipation, dry mouth, and thirst.

The incidence of gastrointestinal side effects may be dose related. Abdominal pain, diarrhea and discolored urine occurred more often in subjects receiving higher doses (1 gram twice daily).

Nervous system

Nervous system side effects have included headache (3.1%). Dizziness, somnolence, insomnia, tremor, and hypesthesia have been reported by less than 1% of the patients.

Other

Adverse effects affecting the body as a whole have included asthenia, fever, pain (pelvic/back), flu syndrome, ear ache, and chills in less than 1% of patients.

Metabolic

Metabolic side effects have included increased creatinine and SGPT in less than 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus, rash, and sweat in less than 1% of patients.

Ocular

Ocular side effects have included pale yellow eye discoloration (<1%).

Respiratory

Respiratory side effects have included epistaxis, rhinitis, lung disease, and pharyngitis.

Genitourinary

Genitourinary side effects have included discolored urine, dysuria, amenorrhea, metrorrhagia, and edema labia.

General

In general, side effects have been mild and transient in nature. The most frequent side effects have included abdominal pain, diarrhea, vomiting, and headache, and the rates of occurrence were not significantly different from placebo.

Musculoskeletal

Musculoskeletal side effects have included myalgia, leg cramps, and spontaneous bone fracture.

Cardiovascular

Cardiovascular side effects have included tachycardia, syncope, and hypertension.

Hematologic

Hematologic side effects have included anemia and leukocytosis.

Renal

Renal side effects have included kidney pain.

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