Side Effects of Alinia (nitazoxanide)

Alinia (nitazoxanide) is an antiprotozoal drug used to treat diarrhea caused by Giardia lamblia and Cryptosporidium parvum. Alinia works by interfering with the conversion of chemicals to energy in protozoal cells.

Common side effects of Alinia include

• diarrhea,
• nausea,
• abdominal pain,
• headaches,
• weakness,
• fever,
• pain,
• allergic reaction,
• chills,
• flu syndrome,
• dizziness,
• drowsiness,
• insomnia,
• tremor,
• vomiting,
• upset stomach,
• loss of appetite,
• gas (flatulence),
• constipation,
• dry mouth,
• thirst,
• discolored urine,
• rash,
• itching,
• eye discoloration,
• earache,
• nosebleed,
• muscle pain, and
• leg cramps.

Serious side effects of Alinia include

• lung disease,
• pharyngitis,
• fast heartbeat,
• fainting,
• low blood pressure,
• painful urination,
• painful or no menstruation,
• kidney pain,
• anemia,
• increased white blood cells, and
• spontaneous bone fracture.

There are no significant drug interactions listed for Alinia.

Alinia has not been adequately evaluated in pregnant women.

It is unknown if Alinia is excreted in human milk. Consult your doctor before breastfeeding. 

Common side effects of nitazoxanide include:

• Diarrhea
• Nausea
• Abdominal pain
• Headaches

Other side effects of nitazoxanide include:

• Asthenia (weakness)
• Fever
• Pain
• Allergic reaction
• Chills
• Flu syndrome
• Dizziness
• Drowsiness
• Insomnia
• Tremor
• Vomiting
• Dyspepsia (upset stomach)
• Anorexia
• Flatulence
• Constipation
• Dry mouth, thirst
• Discolored urine
• Rash
• Pruritus (itching)
• Eye discoloration
• Ear ache
• Bleeding form the nose (epistaxis)
• Muscle pain
• Leg cramps

Diabetic patients and caregivers should be aware that the oral suspension of nitazoxanide contains 1.48 grams of sucrose per 5 mL.

Nitazoxanide should not be used by patients who are allergic to nitazoxanide or any other ingredient in the formulation.

Possible serious side effects of nitazoxanide include:

• Lung disease
• Pharyngitis
• Fast heart beat
• Fainting
• Low blood pressure
• Painful urination
• Painful or no menstruation
• Kidney pain
• Anemia
• Increased white blood cells
• Spontaneous bone fracture

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.

Postmarketing Experience

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

Highly Protein Bound Drugs With Narrow Therapeutic Indices

Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein ( > 99.9%). Therefore, monitor for adverse reactions when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin).