Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tapentadol
Drug ID BADD_D02115
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 D06007
MeSH ID D000077432
PubChem ID 9838022
TTD Drug ID D0K4MH
NDC Product Code Not Available
UNII H8A007M585
Synonyms Tapentadol | 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol | Nucynta | Tapentadol Hydrochloride
Chemical Information
Molecular Formula C14H23NO
CAS Registry Number 175591-23-8
SMILES CCC(C1=CC(=CC=C1)O)C(C)CN(C)C
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)
Unevaluable event08.01.03.0510.007900%Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.002548%Not Available
Breakthrough pain16.32.03.016; 08.01.08.0260.006498%Not Available
Suicidal behaviour19.12.01.0060.000637%Not Available
Impulsive behaviour19.18.01.0010.002166%Not Available
Behaviour disorder19.01.01.0050.000637%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.003249%Not Available
Inadequate analgesia12.02.20.006; 08.06.01.0400.002166%Not Available
Therapeutic product effect decreased08.06.01.0500.012996%Not Available
Therapeutic product effect incomplete08.06.01.0520.003440%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.005288%Not Available
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