Zoloft

N/A

Manufactured by Viatris Specialty LLC

230,558 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Zoloft

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

Top Adverse Reactions

DRUG INEFFECTIVE8,116 reports
NAUSEA8,083 reports
FATIGUE7,589 reports
HEADACHE6,713 reports
ANXIETY6,382 reports
DEPRESSION6,305 reports
DIARRHOEA5,609 reports
DIZZINESS5,456 reports
PAIN5,401 reports
DYSPNOEA4,816 reports
INSOMNIA4,438 reports
VOMITING4,411 reports
FALL4,205 reports
ASTHENIA4,156 reports
OFF LABEL USE3,985 reports
MALAISE3,646 reports
FEELING ABNORMAL3,394 reports
ARTHRALGIA3,190 reports
WEIGHT INCREASED3,115 reports
TREMOR2,926 reports
WEIGHT DECREASED2,891 reports
SOMNOLENCE2,876 reports
SUICIDAL IDEATION2,766 reports
CONDITION AGGRAVATED2,753 reports
DRUG INTERACTION2,712 reports
PRURITUS2,591 reports
DRUG HYPERSENSITIVITY2,574 reports
PNEUMONIA2,574 reports
RASH2,490 reports
PAIN IN EXTREMITY2,489 reports
DEATH2,453 reports
COUGH2,374 reports
BACK PAIN2,345 reports
DECREASED APPETITE2,281 reports
CONFUSIONAL STATE2,261 reports
HYPERTENSION2,260 reports
ABDOMINAL PAIN2,225 reports
PYREXIA2,184 reports
CHEST PAIN2,056 reports
CONSTIPATION1,943 reports
GAIT DISTURBANCE1,869 reports
ABDOMINAL PAIN UPPER1,844 reports
URINARY TRACT INFECTION1,805 reports
HYPERHIDROSIS1,758 reports
MUSCLE SPASMS1,743 reports
PARAESTHESIA1,739 reports
SUICIDE ATTEMPT1,737 reports
MEMORY IMPAIRMENT1,682 reports
HYPOTENSION1,652 reports
MYALGIA1,648 reports
HYPOAESTHESIA1,580 reports
PRODUCT DOSE OMISSION ISSUE1,532 reports
BLOOD PRESSURE INCREASED1,529 reports
LOSS OF CONSCIOUSNESS1,504 reports
ANAEMIA1,499 reports
ABDOMINAL DISCOMFORT1,494 reports
VISION BLURRED1,491 reports
AGITATION1,479 reports
ALOPECIA1,468 reports
MATERNAL EXPOSURE DURING PREGNANCY1,436 reports
OVERDOSE1,435 reports
DEHYDRATION1,405 reports
DIABETES MELLITUS1,387 reports
OEDEMA PERIPHERAL1,381 reports
HYPERSENSITIVITY1,316 reports
PALPITATIONS1,309 reports
PRODUCT USE IN UNAPPROVED INDICATION1,306 reports
HALLUCINATION1,273 reports
NASOPHARYNGITIS1,268 reports
INJECTION SITE PAIN1,250 reports
IRRITABILITY1,240 reports
MYOCARDIAL INFARCTION1,213 reports
BALANCE DISORDER1,200 reports
RENAL FAILURE1,200 reports
GASTROOESOPHAGEAL REFLUX DISEASE1,197 reports
CHILLS1,194 reports
CEREBROVASCULAR ACCIDENT1,189 reports
DISTURBANCE IN ATTENTION1,185 reports
COMPLETED SUICIDE1,184 reports
SYNCOPE1,182 reports
TOXICITY TO VARIOUS AGENTS1,175 reports
INTENTIONAL OVERDOSE1,173 reports
MIGRAINE1,168 reports
SINUSITIS1,159 reports
ERYTHEMA1,146 reports
CONTUSION1,145 reports
PULMONARY EMBOLISM1,124 reports
AGGRESSION1,106 reports
ASTHMA1,087 reports
PANIC ATTACK1,071 reports
DRUG DOSE OMISSION1,069 reports
AMNESIA1,067 reports
EMOTIONAL DISTRESS1,067 reports
NERVOUSNESS1,038 reports
DEPRESSED MOOD1,032 reports
MUSCULAR WEAKNESS1,023 reports
DYSPHAGIA1,022 reports
DYSPEPSIA1,018 reports
HEART RATE INCREASED1,016 reports
COVID 191,015 reports

Report Outcomes

Out of 116,404 classified reports for Zoloft:

  • Serious: 74,192 reports (63.7%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 42,212 reports (36.3%)
Serious 63.7%Non-Serious 36.3%

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

Female75,693 (69.1%)
Male33,452 (30.5%)
Unknown377 (0.3%)

Reports by Age

Age 541,744 reports
Age 601,429 reports
Age 581,399 reports
Age 621,389 reports
Age 651,386 reports
Age 551,379 reports
Age 591,363 reports
Age 561,356 reports
Age 531,342 reports
Age 571,335 reports
Age 611,333 reports
Age 521,258 reports
Age 631,249 reports
Age 501,234 reports
Age 641,225 reports
Age 491,211 reports
Age 511,188 reports
Age 671,169 reports
Age 471,161 reports
Age 481,148 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 Zoloft?

This profile reflects 230,558 FDA FAERS reports that mention Zoloft. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Zoloft?

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

Who manufactures Zoloft?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with Zoloft. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to DRUG INEFFECTIVE

The following drugs share commonly reported adverse reactions with Zoloft:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABATACEPT (78/100)ABEMACICLIB (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 500 MG (65/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)

View all drugs reporting DRUG INEFFECTIVE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsViatris Specialty LLC PortfolioDRUG INEFFECTIVE in Other DrugsNAUSEA in Other DrugsFATIGUE 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.