Tamiflu Side Effects
Please note - some side effects for Tamiflu 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).
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For the consumer For the professional
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Side Effects of Tamiflu - for the consumer
Tamiflu
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 Tamiflu:
Seek medical attention right away if any of these SEVERE side effects occur when using Tamiflu:Nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion or other unusual changes in behavior; fever or sore throat; reddened, blistered, or swollen skin; severe or persistent vomiting or diarrhea.
Tamiflu 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 Tamiflu Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Tamiflu Suspension:Nausea; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion or other unusual changes in behavior; fever or sore throat; reddened, blistered, or swollen skin; severe or persistent vomiting or diarrhea.
For the professional
Tamiflu
Treatment Studies in Adult Patients
A total of 1171 patients who participated in adult phase III controlled clinical trials for the treatment of influenza were treated with Tamiflu. The most frequently reported adverse events in these studies were nausea and vomiting. These events were generally of mild to moderate degree and usually occurred on the first 2 days of administration. Less than 1% of subjects discontinued prematurely from clinical trials due to nausea and vomiting.
Adverse events that occurred with an incidence of ≥1% in 1440 patients taking placebo or Tamiflu 75 mg twice daily in adult phase III treatment studies are shown in Table 3. This summary includes 945 healthy young adults and 495 "at risk" patients (elderly patients and patients with chronic cardiac or respiratory disease). Those events reported numerically more frequently in patients taking Tamiflu compared with placebo were nausea, vomiting, bronchitis, insomnia, and vertigo.
Prophylaxis Studies in Adult Patients
A total of 4187 subjects (adolescents, healthy adults and elderly) participated in phase III prophylaxis studies, of whom 1790 received the recommended dose of 75 mg once daily for up to 6 weeks. Adverse events were qualitatively very similar to those seen in the treatment studies, despite a longer duration of dosing. Events reported more frequently in subjects receiving Tamiflu compared to subjects receiving placebo in prophylaxis studies, and more commonly than in treatment studies, were aches and pains, rhinorrhea, dyspepsia and upper respiratory tract infections. However, the difference in incidence between Tamiflu and placebo for these events was less than 1%. There were no clinically relevant differences in the safety profile of the 942 elderly subjects who received Tamiflu or placebo, compared with the younger population.
| Treatment | Prophylaxis | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event | Placebo N=716 |
Oseltamivir 75 mg bid N=724 |
Placebo/No Prophylaxis* N=1688 |
Oseltamivir 75 mg qd N=1790 |
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| ||||||||
| Nausea (without vomiting) | 40 | (6%) | 72 | (10%) | 56 | (3%) | 129 | (7%) |
| Vomiting | 21 | (3%) | 68 | (9%) | 16 | (1%) | 39 | (2%) |
| Diarrhea | 70 | (10%) | 48 | (7%) | 40 | (2%) | 50 | (3%) |
| Bronchitis | 15 | (2%) | 17 | (2%) | 22 | (1%) | 15 | (1%) |
| Abdominal pain | 16 | (2%) | 16 | (2%) | 25 | (1%) | 37 | (2%) |
| Dizziness | 25 | (3%) | 15 | (2%) | 21 | (1%) | 24 | (1%) |
| Headache | 14 | (2%) | 13 | (2%) | 306 | (18%) | 326 | (18%) |
| Cough | 12 | (2%) | 9 | (1%) | 119 | (7%) | 94 | (5%) |
| Insomnia | 6 | (1%) | 8 | (1%) | 15 | (1%) | 22 | (1%) |
| Vertigo | 4 | (1%) | 7 | (1%) | 4 | (<1%) | 4 | (<1%) |
| Fatigue | 7 | (1%) | 7 | (1%) | 163 | (10%) | 139 | (8%) |
Adverse events included are: all events reported in the treatment studies with frequency ≥1% in the oseltamivir 75 mg bid group.
Additional adverse events occurring in <1% of patients receiving Tamiflu for treatment included unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.
Treatment Studies in Pediatric Patients
A total of 1032 pediatric patients aged 1 to 12 years (including 698 otherwise healthy pediatric patients aged 1 to 12 years and 334 asthmatic pediatric patients aged 6 to 12 years) participated in phase III studies of Tamiflu given for the treatment of influenza. A total of 515 pediatric patients received treatment with Tamiflu for Oral Suspension.
Adverse events occurring in ≥1% of pediatric patients receiving Tamiflu treatment are listed in Table 4. The most frequently reported adverse event was vomiting. Other events reported more frequently by pediatric patients treated with Tamiflu included abdominal pain, epistaxis, ear disorder, and conjunctivitis. These events generally occurred once and resolved despite continued dosing. They did not cause discontinuation of drug in the vast majority of cases.
The adverse event profile in adolescents is similar to that described for adult patients and pediatric patients aged 1 to 12 years.
Prophylaxis in Pediatric Patients
Pediatric patients aged 1 to 12 years participated in a postexposure prophylaxis study in households, both as index cases (134) and as contacts (222). Gastrointestinal events were the most frequent, particularly vomiting. The adverse events noted were consistent with those previously observed in pediatric treatment studies.
| Treatment Trials* | Household Prophylaxis Trial† | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event | Placebo N=517 |
Oseltamivir 2 mg/kg bid N=515 |
No Prophylaxis‡ N=87 |
Prophylaxis
with Oseltamivir QD‡ N=99 |
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| Vomiting | 48 | (9%) | 77 | (15%) | 2 | (2%) | 10 | (10%) |
| Diarrhea | 55 | (11%) | 49 | (10%) | - | 1 | (1%) | |
| Otitis media | 58 | (11%) | 45 | (9%) | 2 | (2%) | 2 | (2%) |
| Abdominal pain | 20 | (4%) | 24 | (5%) | - | 3 | (3%) | |
| Asthma (including aggravated) | 19 | (4%) | 18 | (3%) | 1 | (1%) | 1 | (1%) |
| Nausea | 22 | (4%) | 17 | (3%) | 1 | (1%) | 4 | (4%) |
| Epistaxis | 13 | (3%) | 16 | (3%) | - | 1 | (1%) | |
| Pneumonia | 17 | (3%) | 10 | (2%) | 2 | (2%) | - | |
| Ear disorder | 6 | (1%) | 9 | (2%) | - | - | ||
| Sinusitis | 13 | (3%) | 9 | (2%) | - | - | ||
| Bronchitis | 11 | (2%) | 8 | (2%) | 2 | (2%) | - | |
| Conjunctivitis | 2 | (<1%) | 5 | (1%) | - | - | ||
| Dermatitis | 10 | (2%) | 5 | (1%) | - | - | ||
| Lymphadenopathy | 8 | (2%) | 5 | (1%) | - | - | ||
| Tympanic membrane disorder | 6 | (1%) | 5 | (1%) | - | - | ||
| Age | Prophylaxis (10 days) |
|---|---|
| 1-2 years | 30 mg QD |
| 3-5 years | 45 mg QD |
| 6-12 years | 60 mg QD |
Adverse events included in Table 4 are: all events reported in the treatment studies with frequency ≥1% in the oseltamivir 75 mg bid group.
Observed During Clinical Practice
The following adverse reactions have been identified during postmarketing use of Tamiflu. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to Tamiflu exposure.
Body as a Whole: Swelling of the face or tongue, allergy, anaphylactic/anaphylactoid reactions
Dermatologic: Dermatitis, rash, eczema, urticaria, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis
Digestive: Hepatitis, liver function tests abnormal
Cardiac: Arrhythmia
Neurologic: Seizure, confusion
Metabolic: Aggravation of diabetes
TopMore resources:
Tamiflu - Includes detailed dosage instructions.
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