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)
Syncope17.02.04.008; 02.11.04.015; 24.06.02.0120.003185%
Tachycardia02.03.02.0070.012550%Not Available
Therapeutic response decreased08.06.01.0160.004651%Not Available
Therapeutic response increased08.06.01.0210.003249%Not Available
Thinking abnormal17.02.05.023; 19.10.03.0010.000637%Not Available
Tremor17.01.06.0020.004077%
Unresponsive to stimuli17.02.05.0310.002867%Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.001720%
Urinary retention20.02.02.0110.008473%
Vertigo17.02.12.002; 04.04.01.0030.001274%
Vision blurred17.17.01.010; 06.02.06.0070.005288%
Visual acuity reduced06.02.10.012; 17.17.01.0110.002485%
Visual impairment06.02.10.0130.002039%Not Available
Vomiting07.01.07.0030.016373%
Withdrawal syndrome19.07.06.023; 08.06.02.0120.008600%Not Available
Mental status changes19.07.01.0010.003759%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.002485%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.002039%Not Available
Malignant neoplasm progression16.16.01.0050.006689%Not Available
Drug tolerance08.06.01.0030.005734%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.003568%
Restless legs syndrome17.02.07.008; 15.05.03.0120.000637%Not Available
Adverse event08.06.01.0100.035931%Not Available
Cardiac disorder02.11.01.0030.001593%Not Available
Abnormal behaviour19.01.01.0010.007963%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.002166%
Ill-defined disorder08.01.03.0490.004523%Not Available
Adverse drug reaction08.06.01.0090.004969%Not Available
Drug intolerance08.06.01.0130.008664%Not Available
Psychotic disorder19.03.01.0020.001911%
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