Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Tenofovir disoproxil fumarate
Drug ID BADD_D02156
Description Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name _Viread_, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs for the management of HIV infection as well as for Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001 [FDA label].
Indications and Usage Tenofovir is indicated in combination with other antiretroviral agents for the management of HIV-1 infection in adults and pediatric patients 2 years of age and older. It is also indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older [FDA label]. This drug is also a component of multiple products used for the management of HIV-1 infection [F3418], [F3421]. Safety and effectiveness of tenofovir disoproxil in pediatric patients younger than 2 years of age has not been established to this date [FDA label].
Marketing Status approved; investigational
ATC Code J05AF07
DrugBank ID DB00300
KEGG ID D01982
MeSH ID D000068698
PubChem ID 5486830
TTD Drug ID D0R3FP
NDC Product Code 33342-501; 66406-0103; 68668-351; 31722-535; 42291-800; 47234-0401; 69076-105; 42385-741; 42931-101; 61958-0405; 65862-818; 63285-737; 65862-421; 67835-0020; 70966-0023; 16714-820; 60505-4666; 64380-714; 65862-819; 65862-820; 42385-707; 63285-736; 65015-835; 68554-0031; 82245-0201; 50268-758; 14593-946; 42385-318; 63285-872; 61958-0401; 61958-0406; 70518-3677; 52562-020; 53104-7654; 69097-533; 14799-2022; 50683-0289; 63285-735; 65015-833; 61958-0403; 61958-0404; 59997-0002; 65015-667; 65862-397; 53808-1128
UNII OTT9J7900I
Synonyms Tenofovir | 9-(2-Phosphonylmethoxypropyl)adenine | 9-PMPA (tenofovir) | 9-(2-Phosphonomethoxypropyl)adenine | 9-(2-Phosphonylmethoxypropyl)adenine, (S)-isomer | 9-(2-Phosphonylmethoxypropyl)adenine, (+-)-isomer | Tenofovir Disoproxil Fumarate | Disoproxil Fumarate, Tenofovir | Fumarate, Tenofovir Disoproxil | Tenofovir Disoproxil | Disoproxil, Tenofovir | 9-(2-Phosphonylmethoxypropyl)adenine, (R)-isomer - T357098 | (R)-9-(2-phosphonylmethoxypropyl)adenine | Viread
Chemical Information
Molecular Formula C23H34N5O14P
CAS Registry Number 202138-50-9
SMILES CC(C)OC(=O)OCOP(=O)(COC(C)CN1C=NC2=C(N=CN=C21)N)OCOC(=O)OC(C)C.C(=CC(=O)O)C(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Amylase increased13.05.01.009--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blood cholesterol13.12.01.014---
Blood creatine increased13.13.01.001---
Blood creatine phosphokinase13.04.01.009---
Blood glucose13.02.02.009---
Blood triglycerides13.12.03.004---
Blood triglycerides increased13.12.03.001---
Bone pain15.02.01.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Fanconi syndrome03.06.01.001; 14.01.01.011; 20.05.03.009---
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Glycosuria20.02.01.005--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Haemoglobin13.01.05.018---
Headache17.14.01.001--
Hepatic steatosis09.01.07.003; 14.08.04.005---
The 1th Page    1 2 3    Next   Last    Total 3 Pages