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)
Dry skin23.03.03.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyskinesia17.01.02.006--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.004--
Dyspnoea02.11.05.003; 22.02.01.004--
Dystonia17.01.03.001--Not Available
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Ear pain04.03.01.003--
Eczema23.03.04.006--
Ejaculation delayed21.03.01.001--Not Available
Ejaculation disorder21.03.01.002--
Ejaculation failure21.03.01.003--Not Available
Electric shock12.01.08.032--Not Available
Electrocardiogram QT prolonged13.14.05.004--
Endocrine disorder05.09.01.001--Not Available
Enuresis20.02.02.003; 19.07.04.001--Not Available
Enzyme abnormality14.11.01.015--Not Available
Epistaxis22.04.03.001; 24.07.01.005--
Eructation07.01.02.003--
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Euphoric mood19.04.02.006--
Exophthalmos06.09.04.001; 05.02.02.002--Not Available
Extrapyramidal disorder17.01.02.007--
Eye disorder06.08.03.001--Not Available
Eye haemorrhage12.02.02.012; 24.07.05.002; 06.07.02.001--Not Available
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