Medical Editor: John P. Cunha, DO, FACOEP
Alinia (nitazoxanide) is an antiprotozoal agent used to treat diarrhea in adults and children caused by the protozoa Giardia lamblia, or the protozoa Cryptosporidium parvum. These protozoa are sometimes the cause of travelers' diarrhea. Alinia is generally well tolerated when taken as directed. Side effects of Alinia are uncommon and may include:
- abdominal pain,
- vomiting, or
Serious allergic reactions to Alinia are unlikely, but seek immediate medical attention if you have rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
Doses of Alinia vary according to age. Alinia is taken every 12 hours with food for 3 days. For patients age 1-3 years, 5 mL of Alinia for Oral Suspension (100 mg); patients age 4-11 years, 10 mL of Alinia for Oral Suspension (200 mg); adults and children over 12 years, 1 Alinia Tablet (500 mg) or 25 mL of Alinia for Oral Suspension (500 mg). Many drugs may affect the way that Alinia is metabolized in the body, leading to higher or lower than expected levels of the medication in the blood. Talk to your doctor before taking other prescription or over-the-counter medications including vitamins, minerals, and herbal products during treatment with Alinia. Tell your doctor if you are pregnant before using Alinia. It is not known whether this medication passes into breast milk. Consult your doctor before breastfeeding.
Our Alinia (nitazoxanide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Stop taking nitazoxanide and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Other, less serious side effects may be more likely to occur. Continue to take the medication and talk to your doctor if you experience
- abdominal pain;
- vomiting; or
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Alinia (Nitazoxanide)
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions 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 ALINIA was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received ALINIA Tablets or ALINIA for Oral Suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with ALINIA Tablets or ALINIA 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 ALINIA 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 ALINIA-treated subjects based upon age.
The following adverse reactions have been identified during post approval use of ALINIA. 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 ALINIA 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
Read the entire FDA prescribing information for Alinia (Nitazoxanide)
© Alinia Patient Information is supplied by Cerner Multum, Inc. and Alinia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.