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Prescription medicine

Sertraline Brand names: Zoloft

Sertraline (Zoloft) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $0.0507 per sertraline HCl 100 mg tablet in the October 7, 2026 NADAC survey.

  • Generic listed
  • Boxed warning

Check it at the source: the sertraline FDA label on DailyMed (effective August 8, 2023, Viatris Specialty LLC); the NDA 19839 record on Drugs@FDA; every sertraline label on DailyMed.

Highlights of the record

FDA label of August 8, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

SUICIDAL THOUGHTS AND BEHAVIORS.

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions (5.1) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 )

Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors

Used for

From the label: indications and usage

ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14) ]:

Major depressive disorder (MDD)

Obsessive-compulsive disorder (OCD)

Panic disorder (PD)

Posttraumatic stress disorder (PTSD)

Social anxiety disorder (SAD)

Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ):

Major depressive disorder (MDD)

Forms and strengths

  • 25 mg
  • 50 mg
  • 100 mg
  • 150 mg
  • 200 mg
  • 20 mg/ml

Film-coated tablet; tablet; capsule; solution (concentrate); solution.

On the market

Earliest approval on file
December 30, 1991 Zoloft, Viatris; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
34 first June 30, 2006; 21 with a marketed status in Drugs@FDA
Labelers listed (NDC)
51 of which 47 under generic applications, 2 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.0507 per tablet Sertraline HCl 100 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
3 since 2013 0 Class I among all firms' recalls; latest November 5, 2025; 1 more by firms not listed as its makers
FAERS reports
218,311 through July 30, 2026

What is sertraline used for?

From the label: indications and usage

ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14) ]:

Major depressive disorder (MDD)

Obsessive-compulsive disorder (OCD)

Panic disorder (PD)

Posttraumatic stress disorder (PTSD)

Social anxiety disorder (SAD)

Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ):

Major depressive disorder (MDD)

Obsessive-compulsive disorder (OCD)

Panic disorder (PD)

Posttraumatic stress disorder (PTSD)

Social anxiety disorder (SAD)

Premenstrual dysphoric disorder (PMDD)

Conditions named in the indications of sertraline's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Serotonin Reuptake Inhibitor.

Source: FDA drug label (Zoloft), Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), via openFDA; the full label on DailyMed

What does the patient leaflet for sertraline say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about ZOLOFT?

ZOLOFT and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency. 1. Suicidal thoughts or actions: • ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. o Pay particular attention to such changes when ZOLOFT is started or when the dose is changed. o Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: o attempts to commit suicide o acting aggressive or violent o new or worse depression o feeling agitated, restless, angry or irritable o an increase in activity or talking more than what is normal for you o acting on dangerous impulses o thoughts about suicide or dying o new or worse anxiety or panic attacks o trouble sleeping o other unusual changes in behavior or mood 2. Serotonin Syndrome. […]

From the patient leaflet: What should I avoid while taking ZOLOFT?

ZOLOFT can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZOLOFT affects you. Do not drink alcohol while you take ZOLOFT.

From the patient leaflet: How should I store ZOLOFT?

Store ZOLOFT at room temperature, 68°F to 77°F (20°C to 25°C). • Keep ZOLOFT bottle closed tightly. Keep ZOLOFT and all medicines out of the reach of children.

Source: FDA drug label (Zoloft), Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), via openFDA; the full label on DailyMed

Is there a generic for sertraline (Zoloft)?

The FDA approved the first generic sertraline on June 30, 2006. 34 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists sertraline from 47 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1991 earliest approval on file
  • 2006 first generic approved
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for sertraline (Zoloft)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0507 per Sertraline HCl 100 mg tablet, down 3% from $0.0523 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Sertraline HCl 50 mg tablet (generic)
  • Zoloft 50 mg tablet (brand)
$14.93
$0.0292
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Sertraline 150 mg capsuleGeneric$1.25 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$37.52-76%
Sertraline 20 mg/mL oral concGeneric$0.365 per mLn/a-20%
Sertraline 200 mg capsuleGeneric$1.74 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$52.08-66%
Sertraline HCl 100 mg tabletGeneric$0.0507 per tablet$1.52-3%
Sertraline HCl 25 mg tabletGeneric$0.0288 per tablet$0.865-13%
Sertraline HCl 50 mg tabletGeneric$0.0348 per tablet$1.04-2%
Zoloft 100 mg tabletBrand$14.94 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$448.30+5%
Zoloft 25 mg tabletBrand$15.17 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$455.13+7%
Zoloft 50 mg tabletBrand$14.91 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$447.22+5%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has sertraline been recalled?

The FDA's Enforcement Report lists 4 recalls naming sertraline since 2013: 0 Class I (the most serious), 4 Class II, 0 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of sertraline and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
November 5, 2025Class IILupin Pharmaceuticals Inc.Defective container - seal not adhering to bottles
December 11, 2023Class IILegacy Pharmaceutical Packaging LLCCGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
November 5, 2013Class IIGreenstone LLCLabeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4 …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the sertraline label say about other medicines?

The sertraline label names 48 other medicines in its interaction, contraindication or warning sections. The labels of 41 other medicines name sertraline. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Amiodaronedrug interactionsClass III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).
Aspirindrug interactionsDrugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with ZOLOFT may potentiate the risk of bleeding. … warfarin, carefully monitor the international normalized ratio [See ]. Examples: aspirin, clopidogrel, heparin, warfarin
Atenololdrug interactionsAdditionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when ZOLOFT is administered concomitantly [See Clinical Pharmacology (12.3) ].
Atomoxetinedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … may be needed if ZOLOFT is discontinued. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Buspironedrug interactionsClinical Impact: The concomitant use of serotonergic drugs with ZOLOFT increases the risk of serotonin syndrome. … SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort.
Chlorpromazinedrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);
Cimetidinedrug interactionsInteractions with ZOLOFT Based on pharmacokinetic studies, no dosage adjustment of ZOLOFT is necessary when used in combination with cimetidine.
Clopidogreldrug interactionsDrugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with ZOLOFT may potentiate the risk of bleeding. … carefully monitor the international normalized ratio [See ]. Examples: aspirin, clopidogrel, heparin, warfarin
Desipraminedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … if ZOLOFT is discontinued. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Dextromethorphandrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … discontinued. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Diazepamdrug interactionsAdditionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when ZOLOFT is administered concomitantly [See Clinical Pharmacology (12.3) ].
Digoxindrug interactionsAdditionally, no dosage adjustment is required for diazepam, lithium, atenolol, tolbutamide, digoxin, and drugs metabolized by CYP3A4, when ZOLOFT is administered concomitantly [See Clinical Pharmacology (12.3) ].
DisulfiramcontraindicationsZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction.
Droperidoldrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);

Every other medicine the sertraline label names

Medicine namedSectionWhat the label says
Erythromycindrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);
Fentanylwarnings and precautionsThe risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone …
Flecainidedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … substrate may be needed if ZOLOFT is discontinued. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Fosphenytoindrug interactionsClinical Impact: Phenytoin is a narrow therapeutic index drug. ZOLOFT may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating ZOLOFT. Reduce phenytoin dosage if needed. Examples: phenytoin, fosphenytoin Drugs that Prolong the QTc Interval
Gatifloxacindrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);
Heparindrug interactionsDrugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with ZOLOFT may potentiate the risk of bleeding. … the international normalized ratio [See ]. Examples: aspirin, clopidogrel, heparin, warfarin
Iloperidonedrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);
Isocarboxaziddrug interactionsMonoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome. … intravenous methylene blue [See,, ]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue
LinezolidcontraindicationsCONTRAINDICATIONS ZOLOFT is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of …
Lithiumdrug interactionsClinical Impact: The concomitant use of serotonergic drugs with ZOLOFT increases the risk of serotonin syndrome. … (5.2) ]. Other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort.
Mefloquinedrug interactionsClass III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).
Meperidinewarnings and precautionsThe risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone …
Methadonedrug interactionsClass III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).
Methylene bluecontraindications… of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1) ].
Metoprololdrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Moxifloxacindrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);
Nebivololdrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Perphenazinedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Phenelzinedrug interactionsMonoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome. … methylene blue [See,, ]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue
Phenytoindrug interactionsPhenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug. ZOLOFT may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating ZOLOFT. Reduce phenytoin dosage if needed. Examples: phenytoin, fosphenytoin
PimozidecontraindicationsTaking pimozide [See Drug Interactions (7.1) ].
Procainamidedrug interactionsClass 1A antiarrhythmic medications (e.g., quinidine, procainamide);
Propafenonedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … of a CYP2D6 substrate may be needed if ZOLOFT is discontinued. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Quinidinedrug interactionsClass 1A antiarrhythmic medications (e.g., quinidine, procainamide);
Selegilinedrug interactionsMonoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome. Intervention: ZOLOFT is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See,, ]. …
Sotaloldrug interactionsClass III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).
Tacrolimusdrug interactionsClass III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus).
Thioridazinedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Tolterodinedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Tramadolwarnings and precautionsThe risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone …
Tranylcyprominedrug interactionsMonoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome. Intervention: ZOLOFT is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See,, ]. …
Venlafaxinedrug interactionsDrugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See ]. The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. … dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine
Warfarindrug interactionsProtein-bound drugs: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted.
Ziprasidonedrug interactionsSpecific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);

Other labels that name sertraline

Check sertraline against other medicines

Source: FDA drug label (Zoloft), Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), via openFDA; the full label on DailyMed

What do FAERS reports show for sertraline?

The FDA Adverse Event Reporting System holds 218,311 reports that list sertraline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,962 are coded as a death and 68,336 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Nausea (named in the label)13,859
  • Drug Ineffective (a use or a product term, not a reaction)13,619
  • Fatigue (named in the label)12,825
  • Headache (named in the label)11,104
  • Anxiety (a use or a product term, not a reaction)10,372
  • Diarrhoea (named in the label)10,340
  • Dizziness (named in the label)9,605
  • Depression (a use or a product term, not a reaction)9,506

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as sertraline?

30 other medicines are given the same way (oral) and in the same FDA class as sertraline or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
FluoxetineDepression, Anxiety59 labelers$0.0519 per capsule 40 mg capsuleNo current entry
ParoxetineDepression, Anxiety45 labelers$0.0611 per tablet 20 mg tabletNo current entry
TrazodoneDepression38 labelers$0.0307 per tablet 50 mg tabletNo current entry
EscitalopramDepression, Anxiety44 labelers$0.0632 per tablet 20 mg tabletNo current entry
CitalopramDepression35 labelers$0.026 per tablet 10 mg tabletNo current entry
Fluoxetine and olanzapineDepression3 labelers$3.44 per unit 3-25 mgNo current entry
NefazodoneDepression2 labelers$1.17 per tablet 100 mg tabletNo current entry
BupropionDepression73 labelers$0.0785 per tablet 150 mg tabletNo current entry

Every medicine labeled for the same conditions as sertraline

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does sertraline compare with medicines for the same use?

23 side-by-side pages set sertraline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to sertraline
30 medicines for the same use
Other serotonin reuptake inhibitors
the pharmacologic class, with prices and generics
Sertraline side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other