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)
Lung disorder22.02.07.001--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Menopausal symptoms21.02.02.002--Not Available
Mental disability26.01.01.001--Not Available
Muscle contractions involuntary17.05.03.001; 15.05.03.008--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Nightmare19.02.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Osteoarthritis15.01.04.001--Not Available
Oxygen saturation decreased13.02.01.004--Not Available
Palpitations02.11.04.012--
Panic attack19.06.04.001--Not Available
Paraesthesia17.02.06.005; 23.03.03.094--
Pollakiuria20.02.02.007--
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.009--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Respiratory depression22.02.01.010; 17.02.05.047--Not Available
Restlessness19.11.02.002; 17.02.05.021--
Sedation17.02.04.005--Not Available
Seizure17.12.03.001--
Serotonin syndrome15.05.04.016; 12.03.01.041; 17.05.02.004--Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Suicidal ideation19.12.01.003--
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