Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sertraline hydrochloride
Drug ID BADD_D02011
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 D00825
MeSH ID D020280
PubChem ID 63009
TTD Drug ID D0K0TC
NDC Product Code 65015-821; 65862-013; 42337-201; 43063-754; 50228-467; 53002-2507; 60760-738; 0049-0050; 63629-8127; 65862-224; 68071-4494; 70518-2448; 71093-143; 72865-205; 65977-0056; 51655-173; 52427-672; 55700-948; 65862-011; 68071-4029; 71335-0415; 82982-043; 55111-968; 65862-012; 77777-108; 43063-855; 43602-980; 51655-265; 55154-4692; 60687-253; 68645-521; 68645-522; 68788-8210; 69097-835; 70010-203; 70934-770; 71610-433; 71610-435; 60687-242; 61919-086; 65841-044; 69097-834; 71093-130; 71335-0808; 72789-092; 16714-601; 16714-612; 16714-613; 16729-215; 50228-469; 53002-3192; 55154-4687; 55700-562; 55700-910; 63187-767; 63187-859; 64980-409; 65841-045; 68071-1317; 68071-1318; 68071-3146; 68071-4370; 70518-1350; 70518-2812; 72789-088; 72789-273; 80425-0200; 53869-4900; 53869-4910; 65977-0149; 16714-611; 31722-146; 42337-203; 50090-3203; 50228-468; 52427-664; 53002-1192; 61919-345; 68071-1911; 69097-833; 71205-205; 71335-0210; 71335-0718; 71335-1078; 71610-651; 53104-7590; 42708-092; 43063-033; 43353-447; 43353-970; 50090-6379; 53002-1215; 53808-1127; 59762-0067; 63187-795; 70518-1615; 71205-047; 72189-122; 72789-013; 65862-222; 65977-0002; 42337-202; 43602-981; 55700-340; 60760-091; 60760-612; 0049-4900; 68071-4973; 68788-6437; 70934-188; 71205-455; 71335-0328; 71335-0403; 71335-0510; 72865-206; 80425-0310; 53104-7578; 66022-0304; 16729-216; 16729-217; 42708-124; 43602-979; 50090-2071; 55700-977; 58118-0834; 60687-231; 63629-8774; 65841-043; 68788-6429; 68788-8109; 70518-1748; 70518-3145; 71093-129; 71093-131; 71205-028; 71335-0896; 62512-0080; 31722-147; 50090-3945; 53002-4215; 55700-362; 60760-737; 0049-4910; 0049-4960; 68071-2767; 68645-523; 68788-6835; 68788-7928; 70010-204; 70010-205; 70934-019; 71205-343; 72865-207; 53869-4960; 62350-0043; 83467-0001; 31722-145; 45865-518; 53002-1507; 53002-3215
UNII UTI8907Y6X
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 C17H18Cl3N
CAS Registry Number 79559-97-0
SMILES CNC1CCC(C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)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)
Eye pain06.08.03.002--
Eyelid ptosis06.05.01.002; 17.17.02.004---
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Feeling jittery08.01.09.016---
Flat affect19.04.01.004---
Flatulence07.01.04.002--
Fluid retention14.05.06.002; 20.01.02.003---
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Fracture12.04.02.001; 15.08.02.001--
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Galactorrhoea05.03.04.002; 21.05.02.002---
Gastritis07.08.02.001--
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.007--
Gingival hypertrophy07.09.13.008---
Glaucoma06.03.01.002--
Glossitis07.14.01.001---
Gravitational oedema02.05.04.014; 08.01.07.005---
Gynaecomastia05.05.02.003; 21.05.04.003--
Haematoma24.07.01.001--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Haemoglobin13.01.05.018---
Haemoglobinuria01.06.04.005; 20.02.01.017--
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Haemorrhagic disorder01.01.03.004; 24.07.01.021---
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