Lexapro: adverse event reports filed with FDA

9,424

reports as suspect product

0.1% of all reports · about 419 a year

318

reports, 12 months to June 2026

341 in the 12 months before

64.4%

marked serious by the reporter

83.7% across the class

6.7%

record death among outcomes, as reported

634 reports · not verified by FDA

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 Lexapro reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug ineffectivethe medicine did not work as expected9.4%890
2. Anxietyanxiety8%752
3. Depressionlow mood7.5%703
4. Suicidal ideationthoughts of suicide6.8%645
5. Nauseafeeling sick6.8%642
6. Fatiguetiredness5.7%533
7. Dizzinesslight-headedness or unsteadiness5.6%528
8. Insomniadifficulty sleeping5.4%512
9. Drug interactionan interaction between medicines5.2%489
10. Headachehead pain5.1%479
11. Feeling abnormalfeeling odd or not right4.8%457
12. Tremorshaking4.2%400
13. Weight increasedweight gain4%380
14. Drug hypersensitivityan allergic-type reaction to a medicine3.6%343
15. Completed suicidedeath by suicide3.5%329
16. Somnolencedrowsiness3.4%322
17. Diarrhoealoose or frequent stools3.1%293
18. Off label useused for a purpose or in a way not on the label3.1%293
19. Vomitingbeing sick3.1%289
20. Convulsion3%285
21. Hyperhidrosisexcessive sweating2.9%272
22. Condition aggravatedthe condition being treated got worse2.8%267
23. Suicide attempta suicide attempt2.8%267
24. Confusional stateconfusion2.8%260
25. Agitationrestlessness2.7%257
26. Falla fall2.5%240
27. Astheniaweakness or lack of energy2.5%234
28. Painpain, site not specified2.4%222
29. Malaisegeneral feeling of being unwell2.3%216
30. Loss of consciousnesspassing out2.3%215

Top 30 of 1,313 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 80.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,424 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lexapro 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

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

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.

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 Lexapro as a suspect or interacting product; reports listing it only as a concomitant medication (59,555) 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.