Oseltamivir Side Effects

Some side effects of oseltamivir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to oseltamivir: oral capsule, oral powder for suspension

Along with its needed effects, oseltamivir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking oseltamivir:

Less common
  • Phlegm-producing cough
  • wheezing
Rare
  • Abdominal or stomach cramps or tenderness
  • arm, back, or jaw pain
  • bloating
  • chest pain or discomfort
  • diarrhea, watery and severe, which may also be bloody
  • drooling
  • facial swelling
  • fast or irregular heartbeat
  • hoarseness
  • increased thirst
  • pain
  • shortness of breath
  • unusual weight loss
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • convulsions (seizures)
  • dark urine
  • difficulty with swallowing
  • fainting
  • fast, slow, or irregular heartbeat
  • hives or welts
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • joint or muscle pain
  • light-colored stools
  • loss of bladder control
  • loss of consciousness
  • muscle spasm or jerking of all extremities
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin rash or itching over the entire body
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Some side effects of oseltamivir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • nausea
  • vomiting
Less common
  • Abdominal or stomach pain
  • bloody nose or unexplained nosebleeds (occurs mainly in children)
  • burning, dry, or itching eyes (mainly in children)
  • dizziness
  • ear disorder (occurs mainly in children)
  • excessive tearing of the eyes (mainly in children)
  • redness, pain, or swelling of the eye or eyelid (mainly in children)
  • trouble with sleeping
Rare
  • Pale skin
  • troubled breathing
  • unusual bleeding or bruising
Incidence not known
  • blurred vision
  • cracked, dry, or scaly skin
  • dry mouth
  • flushed, dry skin
  • mood or mental changes
  • skin rash that is encrusted, scaly, and oozing

For Healthcare Professionals

Applies to oseltamivir: oral capsule, oral powder for reconstitution

General

The most common side effects are nausea and vomiting.

The most common side effects reported in patients receiving oseltamivir during studies for the treatment of influenza were nausea, vomiting, bronchitis, insomnia, and vertigo. Nausea and vomiting were generally mild to moderate in severity and usually occurred on the first 2 days of treatment. Less than 1% of patients discontinued oseltamivir early due to nausea and vomiting.

Side effects in prophylaxis studies 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

Gastrointestinal side effects have been the most commonly reported and have included nausea (without vomiting; up to 10%), vomiting (up to 9%), diarrhea (up to 7%), abdominal pain (2%), and pseudomembranous colitis (less than 1%). Gastrointestinal bleeding and hemorrhagic colitis have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included cough (up to 5%) and bronchitis (up to 2%). 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 headache (up to 18%), dizziness (up to 2%), insomnia (1%), and vertigo (up 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 abnormal behavior and delirium (including symptoms such as altered level of consciousness, confusion, delusions, hallucinations, agitation, anxiety, nightmares) during postmarketing experience. Mania has been reported.

Delirium and abnormal behavior leading to injury, with fatal outcomes in some cases, in influenza patients receiving oseltamivir have been reported during postmarketing experience (mostly in Japan). 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 a variety of neurologic and behavioral symptoms (including hallucinations, delirium, and abnormal behavior, with fatal outcomes in some cases) and may occur with encephalitis or encephalopathy but can occur without obvious severe disease, oseltamivir's contribution to these effects has not been established.

Other

Other side effects have included fatigue (up to 8%), humerus fracture (less than 1%), pyrexia (less than 1%), and peritonsillar abscess (less than 1%). Drowsiness and malaise have been reported; however, causality has not been established. Hypothermia has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (less than 1%). Pancytopenia has been reported; however, causality has not been established.

Hypersensitivity

Hypersensitivity side effects have included allergy, anaphylactic/anaphylactoid reactions, and swelling of the face or tongue during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, dermatitis, urticaria, eczema, and serious skin reactions (including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) during postmarketing experience.

Hepatic

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

Cardiovascular

Cardiovascular side effects have included unstable angina (less than 1%). Sudden cardiopulmonary arrest has been reported; however, causality has not been established. Arrhythmia has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included aggravation of diabetes during postmarketing experience. Hyperglycemia has been reported; however, causality has not been established.

Immunologic

Immunologic side effects have included sepsis; however, causality has not been established.

Musculoskeletal

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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