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Oseltamivir Side Effects

It is possible that some side effects of oseltamivir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to oseltamivir: oral capsule, oral powder for suspension

As well as its needed effects, oseltamivir may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking oseltamivir, check with your doctor immediately:

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 oseltamivir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 were nausea and vomiting.

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

Side effects in prophylaxis studies were similar to those in treatment studies, most commonly nausea, vomiting, headache, and pain. Side effects that occurred more frequently than in treatment studies were aches and pains, rhinorrhea, dyspepsia, and upper respiratory tract infections.[Ref]

Nervous system

Very common (10% or more): Headache (up to 18%)
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%): Nausea (without vomiting), 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

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

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]

Dermatologic

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

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]

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

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

Common (1% to 10%): Dysmenorrhea

Ocular

Common (1% to 10%): Conjunctivitis (including red eyes, eye discharge, eye pain)
Rare (less than 0.1%): 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

Frequency not reported: Unstable angina, sudden cardiopulmonary arrest
Postmarketing reports: Cardiac arrhythmia[Ref]

Metabolic

Frequency not reported: Hyperglycemia
Postmarketing reports: Aggravation of diabetes[Ref]

Hematologic

Frequency not reported: Anemia, pancytopenia, lymphadenopathy
Postmarketing reports: Thrombocytopenia[Ref]

References

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2. Moscona A "Neuraminidase inhibitors for influenza." N Engl J Med 353 (2005): 1363-73

3. Montalto NJ, Gum KD, Ashley JV "Updated treatment for influenza A and B." Am Fam Physician 62 (2000): 2467-76

4. "Antiviral drugs prophylaxis and treatment of influenza." Med Lett Drugs Ther 48 (2006): 87-8

5. Hayden FG, Atmar RL, Schilling M, et al. "Use of selective oral neura minidase inhibitor oseltamivir to prevent influenza." N Engl J Med 341 (1999): 1336-43

6. Nicholson KG, Aoki FY, Osterhaus AD, et al. "Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial." Lancet 355 (2000): 1845-50

7. Dreitlein WB, Maratos J, Brocavich J "Zanamivir and oseltamivir: Two new options for the treatment and prevention of influenza." Clin Ther 23 (2001): 327-55

8. Treanor JJ, Hayden FG, Vrooman PS, et al. "Efficacy and safety of the oral neuramidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial." JAMA 283 (2000): 1016-24

9. McNicholl IR, McNicholl JJ "Neuraminidase inhibitors: zanamivir and oseltamivir." Ann Pharmacother 35 (2001): 57-70

10. Cox NJ, Hughes JM "New options for the prevention of influenza." N Engl J Med 341 (1999): 1387-8

11. McClellan K, Perry CM "Oseltamivir: a review of its use in influenza." Drugs 61 (2001): 263-83

12. Snell P, Dave N, Wilson K, et al. "Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate." Br J Clin Pharmacol 59 (2005): 598-601

13. Welliver R, Monto AS, Carewicz O, et al. "Effectiveness of oseltamivir in preventing influenza in household contacts." JAMA 285 (2001): 748-54

14. "Product Information. Tamiflu (oseltamivir)" RocheLaboratories, Nutley, NJ.

15. Bardsley-Elliot A, Noble S "Oseltamivir." Drugs 58 (1999): 851-60

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17. Jefferson T, Demicheli V, Rivetti D, Jones M, Di Pietrantonj C, Rivetti A "Antivirals for influenza in healthy adults: systematic review." Lancet 367 (2006): 303-13

18. Anekthananon T, Pukritayakamee S, Ratanasuwan W, et al. "Oseltamivir and inhaled zanamivir as influenza prophylaxis in Thai health workers: a randomized, double-blind, placebo-controlled safety trial over 16 weeks." J Antimicrob Chemother 68 (2013): 697-707

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