Oseltamivir Side Effects

Brand Names: Tamiflu

Please note - some side effects for Oseltamivir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Oseltamivir - for the Consumer

Oseltamivir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oseltamivir:

Diarrhea; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal behavior; confusion; hallucinations; mood or mental changes; reddened, blistered, peeling, or swollen skin; seizures; severe or persistent nausea, vomiting, or diarrhea; symptoms of infection (eg, fever, chills, persistent sore throat).

Oseltamivir Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oseltamivir Suspension:

Diarrhea; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal behavior; confusion; hallucinations; mood or mental changes; reddened, blistered, peeling, or swollen skin; seizures; severe or persistent nausea, vomiting, or diarrhea; symptoms of infection (eg, fever, chills, persistent sore throat).

Side Effects by Body System

General

The use of oseltamivir has been studied in nearly 1200 patients with influenza in adult phase 3 controlled clinical trials. Less than 1% of these patients discontinued oseltamivir therapy early due to the most commonly reported adverse side effects--nausea and vomiting. No other side effects associated with the use of oseltamivir were more common among treated patients compared with placebo. In phase 3 studies there was no relationship between drug exposure and adverse events or laboratory abnormalities at dosages up to 1000 mg per day.

Adverse effects in prophylaxis studies with adults and adolescents were similar to those in treatment studies. Side effects that occurred more frequently than in treatment studies were aches and pains, rhinorrhea, dyspepsia and upper respiratory tract infections. Gastrointestinal side effects occurred most frequently in prophylaxis studies with pediatric patients.

Gastrointestinal

Gastrointestinal side effects have been the most commonly reported and have included nausea (7% to 9.9%), vomiting (2.1% to 9.4%), diarrhea (3.2% to 6.6%), abdominal pain (2%), and pseudomembranous colitis (less than 1%). While treated patients might be expected to have nausea and vomiting anyway, the incidence of these problems among treated patients was 2 to 3 times higher among patients who received oseltamivir. Gastrointestinal bleeding and hemorrhagic colitis have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included bronchitis (0.7% to 2.3%) and cough (1.2% to 5.6%). The incidences were similar or higher among placebo patients and may represent symptoms of underlying influenza infection. Pneumonia has been reported (less than 1%) and may also be a symptom of underlying disease. Nasopharyngitis, congestion, rhinitis, and dry, sore throat have also been reported.

Nervous system

Nervous system side effects have included dizziness (2.1%), headache (1.8% to 20.1%), insomnia (1.2%), and vertigo (0.3% to 1%). (The incidences were similar or higher among placebo patients and may represent symptoms of underlying influenza infection.) Seizure has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included delirium (including symptoms such as altered level of consciousness, confusion, abnormal behavior, delusions, hallucinations, agitation, anxiety, nightmares) during postmarketing experience.

Abnormal behavior and delirium leading to injury, with fatal outcomes in some cases, with the use of oseltamivir in influenza patients have been reported. Although frequency is unknown, based on oseltamivir usage, these events appear to be uncommon. These events were primarily reported in pediatric patients and often had an abrupt onset and rapid resolution. Since influenza may be associated with neurologic and behavioral symptoms (including hallucinations, delirium, and abnormal behavior, with fatal outcomes in some cases), oseltamivir's contribution to these effects has not been established.

Other

Other side effects have included fatigue (1% to 7.9%), humerus fracture (less than 1%), pyrexia (less than 1%), and peritonsillar abscess (less than 1%). Causality has not been established. Drowsiness and malaise have also been reported.

Hematologic

Hematologic side effects have included anemia (less than 1%) and pancytopenia. Causality has not been established.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and swelling of the face or tongue.

Dermatologic

Dermatologic side effects have included rash, toxic epidermal necrolysis, and erythema multiforme.

Hepatic

Hepatic side effects have included hepatitis and abnormal liver function tests. Hepatic failure has also been reported; however, causality has not been established.

Cardiovascular

Cardiovascular side effects have included angina (less than 1%), arrhythmia, and sudden cardiopulmonary arrest. Causality has not been established.

Metabolic

Metabolic side effects have included aggravation of diabetes and hyperglycemia. Causality has not been established.

Immunologic

Immunologic side effects have included sepsis. Causality has not been established.

Musculoskeletal

Musculoskeletal side effects have included arthralgia in at least one patient.

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