Summary

Commonly reported side effects of oseltamivir include: nausea and vomiting. Other side effects include: abdominal pain. Continue reading for a comprehensive list of adverse effects.

Applies to oseltamivir: oral capsules, oral extemporaneous oral suspension, oral powder for suspension.

Side effects include:

GI effects (nausea, vomiting, diarrhea, abdominal pain), headache, bronchitis, insomnia, vertigo.

For Healthcare Professionals

Applies to oseltamivir: oral capsule, oral powder for reconstitution.

General

The most common side effects were nausea and vomiting.

The most common side effects reported with this drug during studies for the treatment of influenza were nausea, vomiting, and headache; the most common side effects reported in prophylaxis studies were nausea, vomiting, headache, and pain. Most side effects were reported on a single occasion, occurred on the first or second day of therapy, and resolved spontaneously within 1 to 2 days.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)

Common (1% to 10%): Dizziness, vertigo

Frequency not reported: Drowsiness

Postmarketing reports: Seizure/convulsion^[Ref]

Side effects with similar or higher incidence among placebo patients included dizziness and vertigo.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea

Common (1% to 10%): Vomiting, diarrhea, abdominal pain, upper abdominal pain, dyspepsia

Frequency not reported: Pseudomembranous colitis

Postmarketing reports: Gastrointestinal bleeding, hemorrhagic colitis^[Ref]

Side effects with similar or higher incidence among placebo patients included diarrhea, abdominal pain, upper abdominal pain, and dyspepsia.^[Ref]

Respiratory

Common (1% to 10%): Nasal congestion, cough, sore throat, bronchitis, nasopharyngitis, upper respiratory tract infections, influenza, rhinorrhea, sinusitis

Frequency not reported: Pneumonia, peritonsillar abscess, congestion, rhinitis, dry sore throat, epistaxis, asthma, aggravated asthma^[Ref]

Side effects with similar or higher incidence among placebo patients included cough, nasal congestion, sore throat, rhinorrhea, bronchitis, sinusitis, nasopharyngitis, upper respiratory tract infections, and influenza.^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Mania

Postmarketing reports: Abnormal behavior, delirium, altered level of consciousness, confusion, delusions, hallucinations, agitation, anxiety, nightmares, self-injury^[Ref]

Influenza can be associated with various neurologic and behavioral symptoms (including hallucinations, delirium, abnormal behavior), with fatal outcomes in some cases; such events may occur with encephalitis or encephalopathy but can occur without obvious severe disease. There are postmarketing reports (mostly in Japan) of delirium and abnormal behavior leading to injury, with fatal outcomes in some cases, in influenza patients using this drug. Although frequency is unknown, based on usage, these events appear uncommon. These events were primarily reported in pediatric patients, often with abrupt onset and rapid resolution. The contribution of this drug to such events has not been established.

Side effects with similar or higher incidence among placebo patients included insomnia.^[Ref]

Other

Common (1% to 10%): Fatigue, pain, pyrexia, influenza-like illness, pain in limb, otitis media, earache

Uncommon (0.1% to 1%): Tympanic membrane disorder

Frequency not reported: Humerus fracture, malaise, sepsis, facial edema, ear disorder, accidental injury

Postmarketing reports: Hypothermia^[Ref]

Side effects with similar or higher incidence among placebo patients included fatigue, pyrexia, influenza-like illness, and pain in limb.^[Ref]

Dermatologic

Common (1% to 10%): Herpes simplex

Uncommon (0.1% to 1%): Dermatitis (including allergic and atopic dermatitis)

Rare (less than 0.1%): Angioneurotic edema

Postmarketing reports: Rash, urticaria, eczema, serious skin reactions, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme^[Ref]

Side effects with similar or higher incidence among placebo patients included herpes simplex.^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, myalgia^[Ref]

Side effects with similar or higher incidence among placebo patients included back pain, arthralgia, and myalgia.^[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea

Side effects with similar or higher incidence among placebo patients included dysmenorrhea.

Ocular

Common (1% to 10%): Conjunctivitis (including red eyes, eye discharge, eye pain)

Postmarketing reports: Visual disturbances^[Ref]

Hepatic

Uncommon (0.1% to 1%): Elevated liver enzymes

Rare (less than 0.1%): Hepatic failure, fulminant hepatitis (including fatalities)

Frequency not reported: Hepatic function disorder, jaundice

Postmarketing reports: Hepatitis, abnormal liver function tests^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (e.g., allergic skin reactions), allergy, anaphylactic/anaphylactoid reactions, swelling of the face or tongue^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Cardiac arrhythmia

Frequency not reported: Unstable angina, sudden cardiopulmonary arrest

Postmarketing reports: Arrhythmia^[Ref]

Metabolic

Frequency not reported: Hyperglycemia

Postmarketing reports: Aggravation of diabetes^[Ref]

Hematologic

Frequency not reported: Anemia, pancytopenia, lymphadenopathy

Postmarketing reports: Thrombocytopenia^[Ref]