Drugs › Serotonin reuptake inhibitor
Generic name
Sertraline: adverse event reports filed with FDA
44,814 reports list it as a suspect or interacting product, 2004–2026. Class: Serotonin reuptake inhibitor. Also reported as Sertraline /01011402/, Sertraline Tablets, Sertraline 50mg.
- 44,814
- reports as suspect product
- 0.2% of all reports · about 2,000 a year
- 3,714
- reports, 12 months to June 2026
- 4,182 in the 12 months before
- 93%
- marked serious by the reporter
- 83.7% across the class
- 13.6%
- record death among outcomes, as reported
- 6,078 reports · not verified by FDA
44,814 adverse event reports received by FDA list sertraline, a generic name as a suspect or interacting product, from February 2004 to June 2026. A further 59,491 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 3,714 reports listed it, down 11% from 4,182 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 2,000 reports a year and 0.2% of the 20,646,523 reports in the database, and 16.4% of the reports for the serotonin reuptake inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug interaction (7.2%), toxicity to various agents (6%) and drug ineffective (5.5%). A report can list several reactions, so shares add to more than 100%; 3,113 different terms appear across these reports. Drug interaction is recorded in 7.2% of these reports, about the same share as in the median serotonin reuptake inhibitor drug (7.9%).
93% of the reports are marked serious by the reporter (83.7% across the class); 13.6% record death among the outcomes and 36.9% record hospitalisation, as reported. 30.7% of the reports came from physicians, and the largest patient age group is 18 to 44 (31.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Sertraline reports recording the termmedian drug in serotonin reuptake inhibitor
- Drug interactionan interaction between medicines7.2%3,218
- Toxicity to various agentspoisoning or toxic effect of one or more substances6%2,672
- Drug ineffectivethe medicine did not work as expected5.5%2,483
- Nauseafeeling sick4.9%2,205
- Completed suicidedeath by suicide4.7%2,100
- Anxietyanxiety4.6%2,059
- Intentional overdosea deliberate overdose4.3%1,937
- Dizzinesslight-headedness or unsteadiness4.1%1,842
- Headachehead pain3.9%1,743
- Diarrhoealoose or frequent stools3.8%1,704
- Depressionlow mood3.7%1,659
- Fatiguetiredness3.7%1,647
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.7%1,647
- Drug abusemisuse of a medicine3.7%1,638
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3.6%1,628
- Suicidal ideationthoughts of suicide3.6%1,592
- Insomniadifficulty sleeping3.5%1,554
- Vomitingbeing sick3.4%1,513
- Tremorshaking3.4%1,512
- Somnolencedrowsiness3.2%1,425
- Suicide attempta suicide attempt3.1%1,398
- Confusional stateconfusion3.1%1,375
- Off label useused for a purpose or in a way not on the label2.9%1,320
- Condition aggravatedthe condition being treated got worse2.8%1,263
- Intentional self-injury2.8%1,242
- Hyponatraemialow blood sodium2.6%1,161
- Agitationrestlessness2.4%1,071
- Overdosea dose above the recommended amount2.3%1,015
- Falla fall2.2%987
- Malaisegeneral feeling of being unwell2.2%976
Top 30 of 3,113 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 21 drugs in the serotonin reuptake inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 273,115 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 22% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Depression | 10,348 | 23.1% |
| Anxiety | 3,510 | 7.8% |
| Major depression | 867 | 1.9% |
| Bipolar disorder | 657 | 1.5% |
| Obsessive-compulsive disorder | 654 | 1.5% |
| Ill-defined disorder | 351 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 44,814 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Sertraline reports |
|---|---|---|
| Quetiapine | 3,564 | 8% |
| Olanzapine | 2,287 | 5.1% |
| Mirtazapine | 2,270 | 5.1% |
| Omeprazole | 1,917 | 4.3% |
| Diazepam | 1,883 | 4.2% |
| Lorazepam | 1,846 | 4.1% |
| Aripiprazole | 1,834 | 4.1% |
| Risperidone | 1,827 | 4.1% |
| Clonazepam | 1,667 | 3.7% |
| Acetaminophen | 1,623 | 3.6% |
Other products listed in reports where Sertraline is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Sertraline | Serotonin reuptake inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 44,814 | 273,115 | 20,646,523 |
| Share of that pool | — | 16.4% | 0.2% |
| Reports, latest 12 months | 3,714 | — | 1,332,454 |
| Marked serious | 93% | 83.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 136 | 159 | 91 |
| Hospitalisation recorded, per 1,000 reports | 369 | 321 | 213 |
| Consumer-filed share | 24.7% | 30.8% | 45.8% |
| Top term, share of reports | Drug interaction 7.2% | median 7.9% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the serotonin reuptake inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Citalopram | generic | 30,414 | 1,169 | 95.2% |
| Fluoxetine | generic | 28,319 | 1,734 | 93% |
| Paxil | brand | 24,193 | 56 | 57% |
| Escitalopram | generic | 24,176 | 1,839 | 92.5% |
| Zoloft | brand | 21,311 | 295 | 65.5% |
| Paroxetine | generic | 16,204 | 1,170 | 93% |
| Prozac | brand | 11,547 | 276 | 69.5% |
| Sertraline hydrochloride | generic | 11,077 | 1,080 | 85.2% |
| Citalopram hydrobromide | generic | 10,675 | 234 | 96.4% |
| Lexapro | brand | 9,424 | 318 | 64.4% |
| Paroxetine hydrochloride | generic | 8,935 | 268 | 84.2% |
| Sertraline hcl | generic | 7,592 | 0 | 67.7% |
| Fluoxetine hydrochloride | generic | 6,209 | 648 | 91.9% |
| Escitalopram oxalate | generic | 5,063 | 399 | 92.8% |
| Trazodone hydrochloride | generic | 4,213 | 364 | 82.2% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Sertraline reports
How many adverse event reports has FDA received for Sertraline?
44,814 reports list Sertraline as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 3,714 of them arrived in the latest 12 months. Another 59,491 list it only as a concomitant medication.
What reactions are recorded in Sertraline reports?
drug interaction (7.2%), toxicity to various agents (6%), drug ineffective (5.5%), nausea (4.9%) and completed suicide (4.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Sertraline was responsible.
How serious are the reports?
93% are marked serious by the reporter. Among the outcomes recorded, 13.6% of reports include death and 36.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (30.7%), other health professional (30.2%) and consumer or non-health professional (24.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sertraline rising?
3,714 reports in the 12 months to June 2026, down 11% from 4,182 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Sertraline was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Sertraline?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sertraline as a suspect or interacting product; reports listing it only as a concomitant medication (59,491) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.