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)
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Tachycardia02.03.02.007--Not Available
Tension19.06.02.005--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary hesitation20.02.02.009--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Withdrawal syndrome19.07.06.023; 08.06.02.012--Not Available
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Angiopathy24.03.02.007--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
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