Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Oseltamivir
Drug ID BADD_D01627
Description Oseltamivir (marketed as the product TamifluⓇ), is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity. The clinical benefit of use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness.[A180574, L7267, A180580] However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated or progressive illness or for hospitalized patients.[A180583] According to the CDC, data from clinical trials and observational studies have demonstrated that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of some complications (including pneumonia and respiratory failure). They recommend the use of oseltamivir in people with a higher risk of developing complications including children younger than 2 years, people over 65 years, people with some chronic conditions or immunosuppression, pregnant women, residents of long term care facilities, and indigenous communities for example.[L7264] The benefits of oseltamivir use are controversial; a 2014 Cochrane Review of the evidence found that oseltamivir treatment had limited benefit. The authors concluded that oseltamivir use in healthy adults had small, non-specific effects on symptoms (where the time to first alleviation of symptoms was only reduced from 7 to 6.3 days), it had no effect on hospitalizations, and that there was no evidence for any reductions in complications of influenza such as pneumonia.[A179962, A179965, A179968] Due to the risk of adverse effects such as nausea, vomiting, psychiatric effects and renal adverse events in adults and vomiting in children, the harms are generally considered to outweigh the small clinical benefit of use of oseltamivir. Notably, in 2017, the World Health Organization downgraded oseltamivir from its essential medicines list from a "core" drug to a "complementary" drug, due to limited cost-effectiveness.[A179086] Yearly vaccination with the influenza vaccine is still considered the best preventative measure.
Indications and Usage Oseltamivir (Tamiflu) is for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days. It is also used for the prophylaxis of influenza in adult patients and adolescents 13 years and older.
Marketing Status Prescription; Discontinued
ATC Code J05AH02
DrugBank ID DB00198
KEGG ID D08306
MeSH ID D053139
PubChem ID 65028
TTD Drug ID D0O5NK
NDC Product Code 69238-1266; 46708-414; 62332-413; 42291-664; 42291-666; 50090-4650; 69238-1264; 69238-1265; 62332-415; 46708-413; 46708-415; 62332-414
Synonyms Oseltamivir | GS 4104 | GS4104 | GS-4104 | Tamiflu | GS 4071 | GS4071 | GS-4071
Chemical Information
Molecular Formula C16H28N2O4
CAS Registry Number 196618-13-0
SMILES CCC(CC)OC1C=C(CC(C1NC(=O)C)N)C(=O)OCC
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.000506%
Abdominal pain07.01.05.0020.001662%
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.0010.000145%Not Available
Abortion spontaneous18.01.04.0010.001084%Not Available
Acute hepatic failure09.01.03.0010.000038%Not Available
Acute respiratory distress syndrome22.01.03.0010.000321%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000113%Not Available
Ageusia17.02.07.001; 07.14.03.0030.000217%Not Available
Aggression19.05.01.0010.001229%Not Available
Agitation19.06.02.001; 17.02.05.0120.001662%
Agranulocytosis01.02.03.0010.000217%Not Available
Alanine aminotransferase abnormal13.03.01.0010.000145%Not Available
Alanine aminotransferase increased13.03.01.003--
Altered state of consciousness19.07.01.003; 17.02.04.0010.000940%Not Available
Amnesia19.20.01.001; 17.03.02.0010.000650%
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.0010.001084%
Anaphylactic shock24.06.02.004; 10.01.07.0020.000217%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anger19.04.02.0010.000289%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Angle closure glaucoma06.03.01.0010.000217%Not Available
Anxiety19.06.02.002--
Aphonia22.02.05.024; 19.19.01.002; 17.02.08.0090.000145%
Aplasia cutis congenita03.05.01.011; 23.01.04.0040.000038%Not Available
Appendicitis11.01.07.001; 07.19.01.0010.000217%
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