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Alinia Side Effects

Generic Name: nitazoxanide

Note: This document contains side effect information about nitazoxanide. Some of the dosage forms listed on this page may not apply to the brand name Alinia.

For the Consumer

Applies to nitazoxanide: oral powder for suspension, oral tablet

Along with its needed effects, nitazoxanide (the active ingredient contained in Alinia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nitazoxanide:

Incidence Not Known

Some side effects of nitazoxanide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

Incidence Not Known

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.[Ref]

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).[Ref]

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.[Ref]

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.[Ref]

Metabolic

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

Dermatologic

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

Ocular

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

Respiratory

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

Genitourinary

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

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.[Ref]

Musculoskeletal

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

Cardiovascular

Cardiovascular side effects have included tachycardia, syncope, and hypertension.[Ref]

Hematologic

Hematologic side effects have included anemia and leukocytosis.[Ref]

Renal

Renal side effects have included kidney pain.[Ref]

References

1. Stockis A, De Bruyn S, Gengler C, Rosillon D "Nitazoxanide pharmacokinetics and tolerability in man during 7 days dosing with 0.5 g and 1 g b.i.d." Int J Clin Pharmacol Ther 40 (2002): 221-7

2. Fox LM, Saravolatz LD "Nitazoxanide: a new thiazolide antiparasitic agent." Clin Infect Dis 40 (2005): 1173-80

3. "Product Information. Alinia (nitazoxanide)." Romark Laboratories L.C., Tampa, FL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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