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)
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.000019%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Genital hypoaesthesia17.02.06.028; 21.10.05.0120.000083%-
Acute kidney injury20.01.03.016--
Osmotic demyelination syndrome17.16.02.0040.000019%-
Use of accessory respiratory muscles22.12.02.0150.000038%-
Atrioventricular dissociation02.03.01.0120.000032%-
Bladder dysfunction20.03.03.0020.000013%-
Hypoxic-ischaemic encephalopathy17.13.02.006; 22.02.02.011; 24.04.06.0210.000025%-
Foetal growth restriction18.03.01.0020.000108%
Posterior reversible encephalopathy syndrome17.13.02.0070.000057%
Functional gastrointestinal disorder07.11.01.0160.000025%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000162%-
Action tremor17.01.06.0070.000025%-
Lid sulcus deepened06.09.05.0020.000025%-
Rheumatic disorder10.02.01.048; 15.03.04.0180.000013%-
Muscle tone disorder15.05.04.017; 17.05.02.0140.000019%-
Reversible cerebral vasoconstriction syndrome17.08.02.014; 18.06.01.004; 24.04.06.0260.000197%-
Platelet dysfunction01.08.03.0030.000013%-
Faeces soft07.01.03.0080.000038%-
Language disorder17.02.08.015; 19.19.01.0060.000045%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.000025%-
Infantile vomiting07.01.07.010; 18.04.11.0040.000025%-
Irregular breathing22.02.01.0260.000019%-
Intrusive thoughts19.10.03.0080.000070%-
Anal incontinence07.01.06.029; 17.05.01.0210.000032%
Frustration tolerance decreased19.04.02.0160.000084%-
Persistent depressive disorder19.15.01.0060.000019%-
Depersonalisation/derealisation disorder19.14.01.0040.000115%-
Abnormal loss of weight14.03.02.0190.000057%-
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ADReCS-Target
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