Prescription medication · Selective Serotonin Reuptake Inhibitor (SSRI)
sertraline
Also sold as Zoloft. Sertraline is used to treat major depressive disorder in adults.
Data updated 2026-05-15
- 112,198
- FDA reportsOften reported
- 34
- InteractionsSeveral interactions
- 63% less
- Generic vs brandBig savings
- 2
- Recall records
What the data shows
sertraline (Zoloft) is a prescription Selective Serotonin Reuptake Inhibitor (SSRI), more reported than most tracked drugs (112,198 FDA reports), whose generic runs roughly half the brand price or less (63% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
sertraline (Zoloft) is a prescription Selective Serotonin Reuptake Inhibitor (SSRI). Sertraline is used to treat major depressive disorder in adults.
Sertraline is a medicine used to treat depression and other mental health conditions. It helps balance chemicals in your brain to improve your mood and reduce anxiety.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$13.84/unit
Generic Price
$5.17/unit
Generic Savings
63%
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Sertraline is used to treat major depressive disorder in adults.
Common side effects
Nausea, Diarrhea, Headache
Key warnings
Antidepressants may increase the risk of suicidal thoughts or actions in children, teens, and young adults.
The sections below are summarized in plain English from sertraline's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Sertraline is a selective serotonin reuptake inhibitor (SSRI). It works by increasing the amount of serotonin in your brain. Serotonin is a chemical that helps regulate mood, and by blocking its reabsorption, sertraline helps improve mood and reduce symptoms of depression and anxiety.
How to Take It
Take sertraline once a day, either in the morning or evening. You can take it with or without food. The usual starting dose for adults is 50 mg per day. Your doctor may change your dose, but it should not be changed more often than once per week.
This is a plain-language summary of sertraline's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Sertraline may affect your baby. Talk to your doctor about the risks and benefits of taking sertraline during pregnancy and breastfeeding.
This is a plain-language summary of sertraline's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of sertraline's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store sertraline tablets at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 112,198 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for sertraline, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
5,757 reports
- Feeling very tired
Feeling very tired
5,244 reports
- Loose, watery stools
Loose, watery stools
4,654 reports
- Pain in your head
Pain in your head
4,407 reports
- Feeling lightheaded or unsteady
Feeling lightheaded or unsteady
4,121 reports
- Feeling worried or nervous
Feeling worried or nervous
3,958 reports
- Medicine affecting another medicine
Medicine affecting another medicine
3,780 reports
- Throwing up
Throwing up
3,752 reports
- Difficulty breathing
Difficulty breathing
3,339 reports
- Feeling sad and hopeless
Feeling sad and hopeless
3,307 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for sertraline each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where sertraline sits
sertraline has more FDA adverse-event reports than 87% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is sertraline; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 112,198 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
112,198
Reports Mentioning Death
11,431
10.2% of reports — not proof of cause
Hospitalization Reports
38,447
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | NAUSEA | 6,466 |
| 3 | FATIGUE | 5,891 |
| 4 | DIARRHOEA | 5,216 |
| 5 | HEADACHE | 4,927 |
| 6 | DIZZINESS | 4,599 |
| 8 | ANXIETY | 4,553 |
| 9 | DRUG INTERACTION | 4,192 |
| 10 | VOMITING | 4,142 |
| 11 | DEPRESSION | 3,819 |
| 12 | FALL | 3,693 |
| 13 | DYSPNOEA | 3,679 |
| 14 | TOXICITY TO VARIOUS AGENTS | 3,369 |
| 15 | PAIN | 3,248 |
| 16 | INSOMNIA | 3,217 |
| 17 | MALAISE | 3,139 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts or actions in children, teens, and young adults. Watch closely for worsening depression, unusual behavior, or thoughts of suicide. Sertraline is not approved for treating depression in children.
Known Drug Interactions
The selective serotonin reuptake inhibitors sertraline (weak CYP3A4 inducer) and fluoxetine (CYP2D6 inhibitor), and the anti-epileptic drug felbamate (CYP2C19 inhibitor and CYP3A4 inducer) do not affect the pharmacokinetics of clonazepam.
Mechanism: Sertraline does not interfere with how your body breaks down or uses clonazepam.
What to do: These medications can generally be taken together without needing to change your dose.
Drugs that Interfere with Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding.
Mechanism: Both drugs change how your blood cells work to stop bleeding. Taking them together increases your risk of serious bleeding, especially in your stomach or gut.
What to do: Watch for signs of bleeding, such as unusual bruising or dark stools. Your doctor should monitor you carefully while you are taking both medications.
Drug Interactions In patients receiving nonselective monoamine oxidase (MAO) inhibitors in combination with serotoninergic agents (e.g., dexfenfluramine, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, venlafaxine) there have been reports of serious, sometimes fatal, reactions.
Mechanism: Both of these drugs increase a chemical in your brain called serotonin. Taking them together can cause dangerously high levels of serotonin, which can be life-threatening.
What to do: Do not take these two medications together. You must wait a specific amount of time when switching between them to avoid a serious reaction.
If concomitant treatment with sumatriptan and an SSRI (e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) is clinically warranted, appropriate observation of the patient is advised.
Mechanism: Both medications increase serotonin levels in the brain, which can lead to an additive effect when taken together.
What to do: Your doctor should monitor you closely for any signs of too much serotonin if these drugs are used at the same time.
If concomitant treatment with sumatriptan and an SSRI (e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) is clinically warranted, appropriate observation of the patient is advised.
Mechanism: These two drugs belong to the same class and both raise serotonin, which can cause levels to become higher than intended.
What to do: If your provider decides you need both, they should observe you carefully for side effects.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drink alcohol while taking sertraline?
How long does it take for sertraline to work?
Can I stop taking sertraline suddenly?
Will sertraline make me gain weight?
Can sertraline cause sexual side effects?
Is sertraline addictive?
Can I take sertraline with other medications?
What should I do if I have side effects?
Does sertraline interact with grapefruit?
Can I drive while taking sertraline?
What are the common side effects of sertraline?
Does sertraline interact with other medications?
What drug class is sertraline?
Is there a generic version of sertraline?
Is sertraline safe during pregnancy?
Has sertraline been recalled?
Active Recalls
Defective container - seal not adhering to bottles
Lupin Pharmaceuticals Inc.
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Legacy Pharmaceutical Packaging LLC
Related Medications in Selective Serotonin Reuptake Inhibitor (SSRI)
Other drugs grouped near sertraline - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with sertraline →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for sertraline
The FDA label for sertraline (sold under brand names such as Zoloft) classifies it as a prescription-only medication in the Selective Serotonin Reuptake Inhibitor (SSRI) class. Sertraline is used to treat major depressive disorder in adults. Official labeling lists 8 commonly reported side effects, including Nausea, Diarrhea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 112,198 voluntary reports. The database also lists 34 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $5.17 versus $13.84 for the brand - a 63% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 1, 2019
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages