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)
Vasodilation procedure25.03.01.001---
Muscle relaxant therapy25.16.01.001---
Disturbance in sexual arousal19.08.04.003---
Cerebral vasoconstriction17.08.02.012; 24.04.06.025---
Angiopathy24.03.02.007---
Blood alkaline phosphatase increased13.04.02.004--
Adhesion08.01.03.048---
Urine output increased13.13.03.002---
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Benign neoplasm16.02.02.007---
Breast disorder21.05.04.004---
Cardiac disorder02.11.01.003---
Connective tissue disorder10.04.04.026; 15.06.01.006---
Malnutrition14.03.02.004---
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.002---
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Ill-defined disorder08.01.03.049---
Inner ear disorder04.04.02.002---
Lacrimal disorder06.08.02.005---
Blood disorder01.05.01.004---
Autonomic neuropathy17.05.01.009---
Psychotic disorder19.03.01.002--
Hepatobiliary disease09.01.08.003---
Respiratory tract infection11.01.08.017; 22.07.07.001---
Cystitis noninfective20.03.02.001--
Anorectal discomfort07.03.03.003---
Acute kidney injury20.01.03.016--
Reversible cerebral vasoconstriction syndrome17.08.02.014; 18.06.01.004; 24.04.06.026---
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