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.
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: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).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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: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).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopTamiflu Side Effects - for the Professional
Tamiflu
The following serious adverse reactions are discussed below and elsewhere in the labeling:
- Serious skin and hypersensitivity reactions [see Warnings and Precautions (5.1)]
- Neuropsychiatric events [see Warnings and Precautions (5.2)]
The most common adverse reactions are nausea and vomiting.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Treatment Studies in Adult Subjects
A total of 1171 subjects who participated in adult 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 severity 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 subjects taking placebo or Tamiflu 75 mg twice daily in adult treatment studies are shown in Table 6. This summary includes 945 healthy young adults and 495 "at risk" subjects (elderly patients and patients with chronic cardiac or respiratory disease). Those events reported numerically more frequently in subjects taking Tamiflu compared with placebo were nausea, vomiting, bronchitis, insomnia, and vertigo.
Prophylaxis Studies in Adult Subjects
A total of 4187 subjects (adolescents, healthy adults, and elderly) participated in 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 |
Tamiflu 75 mg twice daily N=724 |
Placebo/ No Prophylaxis† N=1688 |
Tamiflu 75 mg once daily N=1790 |
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|
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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%) |
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 Subjects
A total of 1032 pediatric subjects aged 1 to 12 years (including 698 otherwise healthy pediatric subjects aged 1 to 12 years and 334 asthmatic pediatric subjects aged 6 to 12 years) participated in controlled clinical trials of Tamiflu given for the treatment of influenza. A total of 515 pediatric subjects received treatment with Tamiflu for oral suspension.
Adverse events occurring in ≥1% of pediatric subjects receiving Tamiflu treatment are listed in Table 7. The most frequently reported adverse event was vomiting. Other events reported more frequently by pediatric subjects treated with Tamiflu included abdominal pain, epistaxis, ear disorder, and conjunctivitis. These events generally occurred once and resolved despite continued dosing resulting in discontinuation of drug in 8 out of 515 (2%) cases.
The adverse event profile in adolescents is similar to that described for adult subjects and pediatric subjects aged 1 to 12 years.
Prophylaxis Studies in Pediatric Subjects
Pediatric subjects aged 1 to 12 years participated in a postexposure prophylaxis study in households, both as index cases (n=134) and as contacts (n=222). Gastrointestinal events were the most frequent, particularly vomiting. In a separate 6-week, uncontrolled, pediatric seasonal prophylaxis study (n=49), the adverse events noted were consistent with those previously observed.
| Treatment Trials* | Household Prophylaxis Trial† | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event‡ | Placebo N=517 |
Tamiflu 2 mg/kg twice daily N=515 |
No Prophylaxis§ N=87 |
Prophylaxis with Tamiflu once daily§ 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%) | - | - | ||
Prophylaxis Study in Immunocompromised Subjects
In a 12-week seasonal prophylaxis study in 475 immunocompromised subjects, including 18 pediatric subjects 1 to 12 years of age, the safety profile in the 238 subjects receiving Tamiflu was consistent with that previously observed in other Tamiflu prophylaxis clinical trials.
Postmarketing Experience
The following adverse reactions have been identified during postapproval 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, hypothermia
Dermatologic: Rash, dermatitis, urticaria, eczema, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme [see Warnings and Precautions (5.1)]
Digestive: Hepatitis, liver function tests abnormal
Cardiac: Arrhythmia
Gastrointestinal disorders: Gastrointestinal bleeding, hemorrhagic colitis
Neurologic: Seizure
Metabolic: Aggravation of diabetes
Psychiatric: Abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions [see Warnings and Precautions (5.2)]
TopSide Effects by Body System - for Healthcare Professionals
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.
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.
TopMore Tamiflu resources
- Tamiflu Prescribing Information (FDA)
- Tamiflu Monograph (AHFS DI)
- Tamiflu Advanced Consumer (Micromedex) - Includes Dosage Information
- Tamiflu MedFacts Consumer Leaflet (Wolters Kluwer)
- Tamiflu Consumer Overview
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