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)
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.0030.000019%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000045%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000032%
Foreign body sensation in eyes06.01.01.0060.000051%Not Available
Self-injurious ideation19.12.01.0070.000140%Not Available
Tonic clonic movements17.12.03.0060.000045%Not Available
Necrotising colitis07.08.01.0130.000019%Not Available
Ear discomfort04.03.01.005--Not Available
Ocular discomfort06.08.03.0080.000051%Not Available
Pseudodementia19.20.02.0060.000025%Not Available
Orgasmic sensation decreased21.03.02.008; 19.08.01.0030.000019%Not Available
Periventricular leukomalacia18.04.07.003; 17.13.02.0050.000013%Not Available
Migraine without aura24.03.05.006; 17.14.02.0030.000013%Not Available
Eosinophilic pneumonia acute22.01.01.008; 01.02.04.0040.000032%Not Available
Cardiac flutter02.03.02.0120.000045%Not Available
Coronary artery insufficiency24.04.04.016; 02.02.01.0080.000013%Not Available
Musculoskeletal stiffness15.03.05.0270.000222%Not Available
Epigastric discomfort07.01.02.0040.000038%Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000346%Not Available
Growth retardation14.03.02.031; 05.03.02.007; 15.03.05.0160.000045%
Depressive symptom19.15.02.0030.000025%Not Available
Affect lability19.04.01.001--Not Available
Cardiac discomfort02.11.04.0010.000013%Not Available
Vanishing bile duct syndrome09.02.03.0030.000140%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000180%Not Available
Myoclonic epilepsy17.12.03.0070.000019%Not Available
Transaminases increased13.03.04.036--Not Available
Cerebral disorder17.02.10.0170.000053%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.000079%Not Available
Foetal death18.01.02.003; 08.04.01.0110.000102%
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ADReCS-Target
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