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)
Disturbance in attention19.21.02.002; 17.03.03.0010.000637%
Dizziness24.06.02.007; 02.11.04.006; 17.02.05.0030.024909%
Drug abuse19.07.06.0100.006052%Not Available
Drug ineffective08.06.01.0060.097472%Not Available
Drug interaction08.06.03.0010.002676%Not Available
Drug withdrawal syndrome19.07.06.013; 08.06.02.0040.009046%Not Available
Dry mouth07.06.01.0020.003886%
Dysaesthesia23.03.03.077; 17.02.06.0030.002166%
Dysarthria19.19.03.001; 17.02.08.0010.001911%
Dyskinesia17.01.02.0060.000956%
Dysphagia07.01.06.0030.007071%
Dysuria20.02.02.0020.002803%
Emotional disorder19.04.02.0050.001402%Not Available
Epilepsy17.12.03.0020.000637%Not Available
Euphoric mood19.04.02.0060.004969%
Fear19.06.03.0010.000637%Not Available
Feeling abnormal08.01.09.0140.015353%Not Available
Feeling cold08.01.09.0080.001402%Not Available
Feeling drunk08.01.09.0150.000956%Not Available
Feeling jittery08.01.09.0160.004969%Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.002039%
Gastrooesophageal reflux disease07.02.02.0030.003568%
Generalised anxiety disorder19.06.01.0040.002166%Not Available
Generalised tonic-clonic seizure17.12.01.0020.000637%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.002803%Not Available
Hallucination19.10.04.0030.015863%
Hallucination, auditory19.10.04.0040.001274%Not Available
Hallucinations, mixed19.10.04.0080.000637%Not Available
Headache17.14.01.0010.032554%
Hyperhidrosis08.01.03.028; 23.02.03.0040.011212%
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