Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sertraline
Drug ID BADD_D02010
Description Sertraline is a popular antidepressant medication commonly known as a selective serotonin reuptake inhibitor (SSRI), and is similar to drugs such as [Citalopram] and [Fluoxetine]. Despite marked structural differences between compounds in this drug class, SSRIs exert similar pharmacological effects. Several weeks of therapy with sertraline may be required before beneficial effects are noticed. Sertraline displays enhanced safety or tolerability than other classes of antidepressants, which frequently cause high levels of drowsiness, dizziness, blurred vision, and other undesirable effects.[A1846,A187075,T28]
Indications and Usage Sertraline is indicated for the management of major depressive disorder (MDD), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), panic disorder (PD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder (SAD).[L9016] Common off-label uses for sertraline include the prevention of post stroke depression[A187078], generalized anxiety disorder (GAD), fibromyalgia, premature ejaculation, migraine prophylaxis, diabetic neuropathy, and neurocardiogenic syncope.[L5227]
Marketing Status approved
ATC Code N06AB06
DrugBank ID DB01104
KEGG ID D02360
MeSH ID D020280
PubChem ID 68617
TTD Drug ID D0K0TC
NDC Product Code 76282-214; 23155-759; 68180-353; 55700-225; 63187-055; 70518-0153; 70518-1461; 70518-1617; 71335-9714; 0615-7990; 65427-009; 55154-3570; 0615-7991; 76282-212; 0904-6924; 50090-5848; 70518-1040; 23155-757; 70518-2512; 0904-6925; 68180-351; 68180-352; 68071-4400; 63187-212; 68788-7329; 0615-7989; 0904-6926; 55154-3569; 63187-478; 67296-1199; 70934-958; 76282-213; 23155-758; 50090-0989
UNII QUC7NX6WMB
Synonyms Sertraline | Zoloft | Altruline | Lustral | Apo-Sertraline | Apo Sertraline | Aremis | Besitran | Sealdin | Gladem | Novo-Sertraline | Novo Sertraline | ratio-Sertraline | ratio Sertraline | Rhoxal-sertraline | Rhoxal sertraline | Sertraline Hydrochloride | Hydrochloride, Sertraline | Sertraline Hydrochloride (1S-cis)-Isomer | Gen-Sertraline | Gen Sertraline
Chemical Information
Molecular Formula C17H17Cl2N
CAS Registry Number 79617-96-2
SMILES CNC1CCC(C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)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)
Right ventricular hypertrophy02.04.02.0340.000051%-
Meconium in amniotic fluid18.05.01.0070.000025%-
Semen discolouration21.03.03.0080.000057%-
Eosinophilic pneumonia chronic01.02.04.017; 22.01.01.0200.000045%-
Non-alcoholic steatohepatitis09.01.07.035; 14.08.04.0240.000013%-
Foetal macrosomia18.03.01.0030.000013%-
Retroplacental haematoma18.02.01.006; 24.07.03.0290.000013%-
Bradycardia neonatal02.03.02.019; 18.04.07.0040.000102%-
Biliary dyskinesia09.03.02.0040.000013%-
Lymphomatoid papulosis23.03.08.0110.000028%-
Cell death08.03.03.003; 14.11.02.0050.000019%-
Eosinophilic colitis01.02.04.015; 07.08.01.0190.000019%-
Aortic dilatation24.03.04.0070.000019%-
Hypertensive emergency24.08.01.0040.000013%-
Poor sucking reflex17.02.01.008; 18.04.04.0110.000013%-
Negative thoughts19.15.02.0120.000060%-
Sopor17.02.04.021; 19.02.04.0020.000528%-
Psychogenic seizure17.12.03.042; 19.24.01.0070.000045%-
Neonatal aspiration18.04.09.007; 22.11.01.0080.000019%-
Ulnar nerve palsy17.09.02.0170.000013%-
Pharyngeal hypoaesthesia17.02.06.034; 22.04.05.0170.000013%-
Diffuse alveolar damage22.01.01.0190.000019%-
Disturbance in social behaviour19.05.01.0180.000019%-
Foot deformity15.10.03.0050.000045%-
Tricuspid valve disease02.07.05.0040.000025%
Cerebral cyst16.09.05.002; 17.18.05.0020.000013%-
Aortic valve disease02.07.03.0020.000019%
Pyelocaliectasis20.01.06.0110.000013%-
Erosive duodenitis07.04.02.0060.000013%-
Accidental death08.04.01.013; 12.01.08.0400.000019%-
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ADReCS-Target
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