Lexapro

N/A

Manufactured by Allergan, Inc.

269,296 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Lexapro

Lexapro is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. The most commonly reported adverse reactions for Lexapro include FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Lexapro.

Top Adverse Reactions

FATIGUE9,352 reports
NAUSEA9,341 reports
DRUG INEFFECTIVE8,770 reports
HEADACHE7,237 reports
DIARRHOEA6,849 reports
ANXIETY6,568 reports
DIZZINESS6,203 reports
DEPRESSION6,069 reports
OFF LABEL USE6,007 reports
PAIN5,729 reports
FALL5,471 reports
DYSPNOEA5,379 reports
VOMITING5,191 reports
INSOMNIA4,439 reports
ASTHENIA4,398 reports
SOMNOLENCE4,006 reports
CONDITION AGGRAVATED3,969 reports
MALAISE3,942 reports
ARTHRALGIA3,820 reports
DRUG INTERACTION3,765 reports
RASH3,324 reports
WEIGHT DECREASED3,285 reports
WEIGHT INCREASED3,272 reports
TREMOR3,249 reports
DEATH3,189 reports
SUICIDAL IDEATION3,143 reports
FEELING ABNORMAL3,134 reports
PRURITUS3,132 reports
PAIN IN EXTREMITY2,976 reports
PYREXIA2,963 reports
PNEUMONIA2,955 reports
CONFUSIONAL STATE2,881 reports
COUGH2,831 reports
DECREASED APPETITE2,782 reports
ABDOMINAL PAIN2,666 reports
COMPLETED SUICIDE2,552 reports
CONSTIPATION2,457 reports
BACK PAIN2,422 reports
SUICIDE ATTEMPT2,403 reports
URINARY TRACT INFECTION2,246 reports
HYPOTENSION2,232 reports
PRODUCT DOSE OMISSION ISSUE2,226 reports
GAIT DISTURBANCE2,219 reports
HYPERTENSION2,185 reports
ABDOMINAL PAIN UPPER2,184 reports
HYPERHIDROSIS2,071 reports
TOXICITY TO VARIOUS AGENTS2,013 reports
ACUTE KIDNEY INJURY1,961 reports
CHEST PAIN1,943 reports
PRODUCT USE IN UNAPPROVED INDICATION1,936 reports
OVERDOSE1,920 reports
MEMORY IMPAIRMENT1,896 reports
COVID 191,885 reports
INTENTIONAL OVERDOSE1,879 reports
PARAESTHESIA1,874 reports
MUSCLE SPASMS1,864 reports
BLOOD PRESSURE INCREASED1,843 reports
MYALGIA1,801 reports
LOSS OF CONSCIOUSNESS1,780 reports
ANAEMIA1,779 reports
DEHYDRATION1,773 reports
ABDOMINAL DISCOMFORT1,742 reports
HYPOAESTHESIA1,696 reports
PULMONARY EMBOLISM1,689 reports
AGITATION1,642 reports
ALOPECIA1,639 reports
SEROTONIN SYNDROME1,629 reports
NASOPHARYNGITIS1,615 reports
PALPITATIONS1,583 reports
VISION BLURRED1,579 reports
SYNCOPE1,488 reports
TACHYCARDIA1,488 reports
INJECTION SITE PAIN1,466 reports
BALANCE DISORDER1,458 reports
RENAL FAILURE1,433 reports
HYPERSENSITIVITY1,429 reports
HALLUCINATION1,412 reports
MIGRAINE1,407 reports
CHILLS1,404 reports
CHRONIC KIDNEY DISEASE1,383 reports
SEIZURE1,332 reports
OEDEMA PERIPHERAL1,323 reports
DRUG HYPERSENSITIVITY1,298 reports
CEREBROVASCULAR ACCIDENT1,293 reports
HYPONATRAEMIA1,283 reports
MUSCULAR WEAKNESS1,264 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1,248 reports
SINUSITIS1,245 reports
PERIPHERAL SWELLING1,235 reports
ASTHMA1,221 reports
ERYTHEMA1,221 reports
CONTUSION1,210 reports
DIABETES MELLITUS1,205 reports
ELECTROCARDIOGRAM QT PROLONGED1,198 reports
SLEEP DISORDER1,188 reports
FLUSHING1,152 reports
GASTROOESOPHAGEAL REFLUX DISEASE1,149 reports
STRESS1,147 reports
DRUG DOSE OMISSION1,138 reports
EMOTIONAL DISTRESS1,133 reports

Report Outcomes

Out of 136,857 classified reports for Lexapro:

  • Serious: 91,930 reports (67.2%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 44,927 reports (32.8%)
Serious 67.2%Non-Serious 32.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female86,966 (68.8%)
Male39,100 (30.9%)
Unknown325 (0.3%)

Reports by Age

Age 651,843 reports
Age 561,822 reports
Age 571,811 reports
Age 611,808 reports
Age 631,796 reports
Age 621,790 reports
Age 601,721 reports
Age 521,707 reports
Age 551,693 reports
Age 641,678 reports
Age 581,650 reports
Age 531,644 reports
Age 591,629 reports
Age 661,593 reports
Age 721,581 reports
Age 541,554 reports
Age 491,553 reports
Age 671,543 reports
Age 501,519 reports
Age 691,510 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Lexapro?

This profile reflects 269,296 FDA FAERS reports that mention Lexapro. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Lexapro?

Frequently reported terms in FAERS include FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE, DIARRHOEA, ANXIETY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Lexapro?

Labeling and FAERS entries often list Allergan, Inc. in connection with Lexapro. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Allergan, Inc.

Explore other medications manufactured by Allergan, Inc. and compare their safety profiles:

ASENAPINE MALEATE (78/100)BIMATOPROST (45/100)CARBOXYMETHYLCELLULOSE SODIUM (65/100)CARIPRAZINE (72/100)CYCLOSPORINE (85/100)DAPSONE (78/100)DEXAMETHASONE (87/100)ESCITALOPRAM (72/100)ESTRADIOL (65/100)KETOROLAC TROMETHAMINE (78/100)LINACLOTIDE (72/100)MILNACIPRAN HYDROCHLORIDE (65/100)

View all Allergan, Inc. drugs →

Drugs Also Linked to FATIGUE

The following drugs share commonly reported adverse reactions with Lexapro:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABALOPARATIDE (35/100)ABATACEPT (78/100)ABEMACICLIB (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACALABRUTINIB (78/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 325MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)

View all drugs reporting FATIGUE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsAllergan, Inc. PortfolioFATIGUE in Other DrugsNAUSEA in Other DrugsDRUG INEFFECTIVE in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.