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 discomfort22.12.03.015; 07.05.05.0080.000019%Not Available
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Genital hypoaesthesia21.10.05.012; 17.02.06.0280.000083%Not Available
Acute kidney injury20.01.03.016--
Osmotic demyelination syndrome17.16.02.0040.000019%Not Available
Use of accessory respiratory muscles22.12.02.0150.000038%Not Available
Atrioventricular dissociation02.03.01.0120.000032%Not Available
Bladder dysfunction20.03.03.0020.000013%Not Available
Hypoxic-ischaemic encephalopathy24.04.06.021; 22.02.02.011; 17.13.02.0060.000025%Not Available
Foetal growth restriction18.03.01.0020.000108%
Posterior reversible encephalopathy syndrome17.13.02.0070.000057%
Functional gastrointestinal disorder07.11.01.0160.000025%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000162%Not Available
Action tremor17.01.06.0070.000025%Not Available
Lid sulcus deepened06.09.05.0020.000025%Not Available
Rheumatic disorder15.03.04.018; 10.02.01.0480.000013%Not Available
Muscle tone disorder17.05.02.014; 15.05.04.0170.000019%Not Available
Reversible cerebral vasoconstriction syndrome24.04.06.026; 17.08.02.014; 18.06.01.0040.000197%Not Available
Platelet dysfunction01.08.03.0030.000013%Not Available
Faeces soft07.01.03.0080.000038%Not Available
Language disorder19.19.01.006; 17.02.08.0150.000045%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000025%Not Available
Infantile vomiting18.04.11.004; 07.01.07.0100.000025%Not Available
Irregular breathing22.02.01.0260.000019%Not Available
Intrusive thoughts19.10.03.0080.000070%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000032%
Frustration tolerance decreased19.04.02.0160.000084%Not Available
Persistent depressive disorder19.15.01.0060.000019%Not Available
Depersonalisation/derealisation disorder19.14.01.0040.000115%Not Available
Abnormal loss of weight14.03.02.0190.000057%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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