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)
Postmenopausal haemorrhage21.02.01.002; 24.07.03.0020.000019%-
Parkinsonian gait08.01.02.005; 17.01.05.0050.000045%-
Fluid intake reduced14.05.10.0010.000013%-
Painful erection21.03.01.0090.000013%-
Food craving14.03.01.009; 19.09.01.0100.000013%-
Cutaneous lupus erythematosus10.04.03.007; 15.06.02.007; 23.03.02.0080.000013%-
Colitis microscopic07.08.01.0110.000643%-
Rectal tenesmus07.03.03.001; 15.05.03.011---
Neonatal tachypnoea18.04.09.003; 22.11.01.0030.000025%-
Hypoaesthesia oral07.05.05.003; 17.02.06.0210.000166%-
Paraesthesia oral07.05.05.035; 17.02.06.0080.000098%-
Anxiety disorder19.06.01.0020.000032%-
Bipolar disorder19.16.01.0030.000083%-
Cognitive disorder17.03.03.003; 19.21.02.0010.000312%
Female sexual dysfunction19.08.05.001; 21.03.02.004---
Male sexual dysfunction19.08.05.003; 21.03.02.0120.000051%-
Major depression19.15.01.0030.000064%-
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.0030.000051%-
Metabolic disorder14.11.01.0010.000028%-
Dyslipidaemia14.08.04.0150.000032%-
Cystoid macular oedema06.04.06.010; 12.02.02.0050.000038%-
Dysgraphia17.02.03.0060.000032%-
Retroperitoneal haematoma07.07.02.005; 24.07.01.0600.000013%-
Aortic disorder24.03.04.0040.000025%-
Vasodilation procedure25.03.01.001---
Restless legs syndrome15.05.03.012; 17.02.07.0080.000228%-
Disturbance in sexual arousal19.08.04.0030.000064%-
Cerebral vasoconstriction17.08.02.012; 24.04.06.0250.000013%-
Epidermal necrosis23.03.03.0350.000013%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.000363%
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ADReCS-Target
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