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)
Hypersensitivity10.01.03.0030.010257%
Hypersomnia19.02.05.001; 17.15.01.0010.002485%
Hypertension24.08.02.0010.005542%
Hypotension24.06.03.0020.004459%
Hypoxia22.02.02.0030.000637%
Ileus07.13.01.0010.002230%
Ileus paralytic07.02.05.0010.000956%Not Available
Incoherent19.10.03.006; 17.02.08.0020.000637%Not Available
Influenza like illness08.01.03.0100.003249%
Insomnia19.02.01.002; 17.15.03.0020.017073%
Intestinal obstruction07.13.01.0020.000637%Not Available
Irritability08.01.03.011; 19.04.02.0130.005160%
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.0030.000637%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.003504%
Lip swelling07.05.04.005; 23.04.01.007; 10.01.05.0050.002166%Not Available
Liver disorder09.01.08.0010.000637%Not Available
Logorrhoea19.19.02.001; 17.02.08.0060.002166%Not Available
Loss of consciousness17.02.04.0040.004141%Not Available
Mental impairment17.03.03.002; 19.21.02.0030.000637%Not Available
Middle insomnia19.02.01.003; 17.15.03.0030.002166%Not Available
Migraine24.03.05.003; 17.14.02.0010.006498%Not Available
Miosis17.02.11.002; 06.05.03.0030.004905%Not Available
Mood altered19.04.02.0070.000637%Not Available
Mood swings19.04.03.0010.002485%Not Available
Muscle twitching15.05.03.0050.000956%Not Available
Mydriasis17.02.11.003; 06.05.03.0040.000637%Not Available
Nausea07.01.07.0010.034402%
Nervousness19.06.02.0030.005606%Not Available
Neuralgia17.02.07.0050.000637%
Nightmare19.02.03.0030.003568%Not Available
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