DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Tamiflu (Oseltamivir Phosphate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 (see Table 3). 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.

Table 3 Most Frequent Adverse Events in Studies in Naturally Acquired Influenza in Patients 13 Years of Age and Older
Treatment Prophylaxis
Adverse Event Placebo

N=716
Oseltamivir
75 mg bid
N=724
Placebo/No ProphylaxisThe majority of subjects received placebo; 254 subjects from a randomized, open-label post exposure prophylaxis study in households did not receive placebo or prophylaxis therapy.
N=1688
Oseltamivir
75 mg qd
N=1790
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 (see Table 4).

Table 4 Most Frequent Adverse Events Occurring in Children Aged 1 to 12 Years in Studies in Naturally Acquired Influenza
Treatment TrialsPooled data from Phase III trials of TAMIFLU treatment of naturally acquired influenza. Household Prophylaxis TrialA randomized, open-label study of household transmission in which household contacts received either prophylaxis or no prophylaxis but treatment if they became ill. Only contacts who received prophylaxis or who remained on no prophylaxis are included in this table.
Adverse Event Placebo

N=517
Oseltamivir
2 mg/kg bid
N=515
No Prophylaxis 1
N=87
Prophylaxis with Oseltamivir
QD
N=99
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%) - -

1 Unit dose = age-based dosing

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 (see PRECAUTIONS)

Digestive: Hepatitis, liver function tests abnormal

Cardiac: Arrhythmia

Gastrointestinal disorders: Gastrointestinal bleeding, hemorrhagic colitis

Neurologic: Seizure

Metabolic: Aggravation of diabetes

Psychiatric: Delirium, including symptoms such as altered level of consciousness, confusion, abnormal behavior, delusions, hallucinations, agitation, anxiety, nightmares (see PRECAUTIONS)



REPORTS OF SUSPECTED TAMIFLU SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Tamiflu. The information is not vetted and should not be considered as verified clinical evidence.

Possible Tamiflu side effects / adverse reactions in 29 year old male

Reported by a physician from France on 2011-10-14

Patient: 29 year old male

Reactions: Hallucination

Suspect drug(s):
Tamiflu



Possible Tamiflu side effects / adverse reactions in 63 year old male

Reported by a physician from United States on 2011-10-15

Patient: 63 year old male weighing 90.9 kg (200.0 pounds)

Reactions: Hypotension

Suspect drug(s):
Tamiflu

Other drugs received by patient: Amoxicillin; Diovan HCT; Levothyroxine Sodium; Wellbutrin



Possible Tamiflu side effects / adverse reactions in 33 year old female

Reported by a physician from Japan on 2011-10-25

Patient: 33 year old female

Reactions: Stevens-Johnson Syndrome, Liver Disorder

Suspect drug(s):
Tamiflu



See index of all Tamiflu side effect reports >>

Drug label data at the top of this Page last updated: 2009-08-31

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014