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)
Pain08.01.08.0040.031344%
Palpitations02.11.04.0120.013952%
Pancreatitis07.18.01.0010.001593%
Panic attack19.06.04.0010.003886%Not Available
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.0090.000956%
Pruritus23.03.12.0010.019112%
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.002357%Not Available
Pulmonary oedema02.05.02.003; 22.01.03.0030.000637%
Pupillary reflex impaired17.02.11.007; 06.05.03.0090.000637%Not Available
Rash vesicular23.03.13.0090.002166%Not Available
Renal pain20.02.03.0030.001402%Not Available
Respiratory arrest22.02.01.0090.000637%Not Available
Respiratory depression22.02.01.010; 17.02.05.0470.004141%Not Available
Restlessness19.11.02.002; 17.02.05.0210.002357%
Rhinorrhoea22.12.03.0210.001720%
Sedation17.02.04.0050.003440%Not Available
Seizure17.12.03.0010.007326%
Serotonin syndrome12.03.01.041; 17.05.02.004; 15.05.04.0160.010193%Not Available
Sinus tachycardia02.03.03.0100.001911%
Sleep disorder19.02.04.0010.002039%Not Available
Sleep terror19.02.03.008; 17.15.02.0060.001402%Not Available
Sneezing22.12.03.0240.003249%
Somnambulism17.15.02.004; 19.02.03.0060.001402%Not Available
Somnolence19.02.05.003; 17.02.04.0060.024973%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.001593%Not Available
Suicidal ideation19.12.01.0030.002548%
Suicide attempt19.12.01.0040.011149%
Swelling08.01.03.0150.007135%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.002485%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.001402%Not Available
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