Nitazoxanide Side Effects

It is possible that some side effects of nitazoxanide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nitazoxanide: oral powder for suspension, oral tablet

Some nitazoxanide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Stomach pain
Less common
  • Diarrhea
  • headache
  • vomiting
Rare
  • Appetite increase
  • bloated full feeling
  • discolored urine
  • dizziness
  • enlarged salivary glands
  • excess air or gas in stomach or intestines
  • eye discoloration, pale yellow
  • fever
  • general feeling of discomfort or illness
  • infection
  • itching skin
  • loss of appetite
  • nausea
  • passing gas
  • runny nose
  • sneezing
  • stuffy nose
  • sweating
  • unusual tiredness or weakness
  • weight loss

For Healthcare Professionals

Applies to nitazoxanide: oral powder for reconstitution, oral tablet

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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