"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
Alinia Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Alinia (nitazoxanide) is 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. It is an antiprotozoal agent. This medication is generally well tolerated when taken as directed. Serious allergic reactions 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 breast-feeding.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Alinia in Detail - Patient Information: Side Effects
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)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Alinia Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Alinia (Nitazoxanide)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Alinia FDA Prescribing Information: Side Effects
Alinia (nitazoxanide) Tablets: In controlled and uncontrolled clinical studies of 1,628 HIV-uninfected patients age 12 years and older who received various dosage regimens of Alinia (nitazoxanide) Tablets, the most common adverse events reported regardless of causality assessment were: abdominal pain (6.7%), diarrhea (4.3%), headache (3.1%) and nausea (3.1%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo. In placebo-controlled trials of HIV-uninfected patients age 12 years and older who received Alinia (nitazoxanide) Tablets for the treatment of diarrhea caused by Giardia lamblia, approximately 1% of patients discontinued therapy because of an adverse event.
Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Alinia (nitazoxanide) Tablets are listed below:
Body as a Whole: asthenia, fever, pain, allergic reaction, pelvic
pain, chills, chills and fever, flu syndrome.
Nervous System: dizziness, somnolence, insomnia, tremor, hypesthesia.
Digestive System: vomiting, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst.
Urogenital System: discolored urine, dysuria, amenorrhea, metrorrhagia, kidney pain, edema labia.
Metabolic & Nutrition: increased SGPT.
Hemic & Lymphatic Systems: anemia, leukocytosis.
Skin: rash, pruritus.
Special Senses: eye discoloration, ear ache.
Respiratory System: epistaxis, lung disease, pharyngitis.
Cardiovascular System: tachycardia, syncope, hypertension.
Muscular System: myalgia, leg cramps, spontaneous bone fracture.
Alinia (nitazoxanide) for Oral Suspension: In controlled and uncontrolled clinical studies of 613 HIV-uninfected pediatric patients who received Alinia (nitazoxanide) for Oral Suspension, the most frequent adverse events reported regardless of causality assessment were: abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials, the rates of occurrence of these events did not differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of adverse events.
Adverse events occurring in less than 1% of the pediatric patients participating in clinical trials of Alinia (nitazoxanide) for Oral Suspension are listed below:
Digestive System: nausea, anorexia, flatulence, appetite increase,
enlarged salivary glands.
Body as a Whole: fever, infection, malaise.
Metabolic & Nutrition: increased creatinine, increased SGPT. Skin: pruritus, sweat.
Special Senses: eye discoloration (pale yellow).
Respiratory System: rhinitis.
Nervous System: dizziness.
Urogenital System: discolored urine.
The adverse events seen in adult patients treated with Alinia (nitazoxanide) for Oral Suspension were similar to those observed in adult patients treated with Alinia (nitazoxanide) Tablets.
Read the entire FDA prescribing information for Alinia (Nitazoxanide)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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