Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Tapentadol hydrochloride
Drug ID BADD_D02116
Description Opioid analgesic for treatment of moderate to severe pain. FDA approved on Nov 20, 2008.
Indications and Usage The immediate-release formulation of tapentadol is indicated for the relief of moderate to severe acute pain. The long-acting formulation serves as a continuous, around-the-clock analgesic that is indicated for the relief of moderate to severe chronic pain or neuropathic pain associated with diabetic peripheral neuropathy.
Marketing Status approved
ATC Code N02AX06
DrugBank ID DB06204
KEGG ID D10199
MeSH ID D000077432
PubChem ID 9838021
TTD Drug ID D0K4MH
NDC Product Code 65267-101; 24510-100; 24510-116; 24510-075; 24510-174; 24510-291; 24510-050; 24510-232; 17180-9780; 24510-058; 0792-5671
UNII 71204KII53
Synonyms Tapentadol | 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol | Nucynta | Tapentadol Hydrochloride
Chemical Information
Molecular Formula C14H24ClNO
CAS Registry Number 175591-09-0
SMILES CCC(C1=CC(=CC=C1)O)C(C)CN(C)C.Cl
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 discomfort07.01.06.001--Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase increased13.03.04.005--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.008--Not Available
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Blood pressure decreased13.14.03.002--Not Available
Bradycardia02.03.02.002--Not Available
Bundle branch block left02.03.01.007--Not Available
Chills08.01.09.001; 15.05.03.016--
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Cough22.02.03.001--
Depressed level of consciousness17.02.04.002--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug abuse19.07.06.010--Not Available
Drug hypersensitivity10.01.01.001--Not Available
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