Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Solriamfetol
Drug ID BADD_D02595
Description Solriamfetol marketed under the brand name Sunosi by Jazz Pharmaceuticals in the United States is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated in treating daytime sleepiness associated with narcolepsy or obstructive sleep apnea[FDA Label]. Solriamfetol was given FDA approval in 2019[FDA Label].
Indications and Usage Solriamfetol is indicated for treatment of daytime sleepiness associated with obstructive sleep apnea and narcolepsy, but is not a treatment for the underlying airway obstruction in apnea patients[FDA Label][A176534,A176744].
Marketing Status approved
ATC Code N06BA14
DrugBank ID DB14754
KEGG ID D11315
MeSH ID C000623308
PubChem ID 10130337
TTD Drug ID D0M3CV
NDC Product Code 44639-002; 68727-351; 68727-350; 81968-350; 81968-351; 44639-003; 44639-004
UNII 939U7C91AI
Synonyms solriamfetol | (2R)-2-amino-3-phenylpropyl carbamate | benzenepropanol, beta-amino-, carbamate (ester), (betaR)- | ADX-N05 | Sunosi | (R)-2-amino-3-phenylpropylcarbamate hydrochloride | JZP-110 | solriamfetol hydrochloride
Chemical Information
Molecular Formula C10H14N2O2
CAS Registry Number 178429-62-4
SMILES C1=CC=C(C=C1)CC(COC(=O)N)N
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)
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.0270.000137%-
Suicidal ideation19.12.01.0030.000062%
Tachycardia02.03.02.0070.000456%-
Therapeutic response decreased08.06.01.0160.000849%-
Therapeutic response unexpected08.06.01.0010.000212%-
Tremor17.01.06.0020.000425%
Fibromyalgia15.05.02.0020.000137%-
Haemorrhage urinary tract20.02.03.005; 24.07.01.0070.000062%-
Restless legs syndrome15.05.03.012; 17.02.07.0080.000137%-
Decreased appetite08.01.09.028; 14.03.01.0050.000425%
Drug intolerance08.06.01.0130.000318%-
Drug effect less than expected08.06.01.0360.000212%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.000531%-
Heavy menstrual bleeding21.01.03.0050.000243%-
Therapeutic product effect incomplete08.06.01.0520.000425%-
Therapeutic response shortened08.06.01.0620.000456%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.000212%-
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