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Sertraline Side Effects

The most commonly reported side effects of sertraline include nausea, fatigue, and headache, based on 215,773 FDA adverse event reports from 2004 to 2025. 5.2% of reports found the drug to be ineffective.

#1 Reported: NauseaAll side effects ↓Top Co-Medication: Quetiapine-fumarateDrug interactions ↓64% of Reports Are AdultDemographics ↓

Sertraline side effects

Percentages show how often each reaction appears relative to total reports for sertraline.

1
Drug Ineffective5.2%11,256
2
Nausea5.1%11,062
3
Fatigue5.0%10,878
4
Headache4.3%9,172
5
Diarrhoea4.0%8,737
6
Anxiety3.7%8,065
7
Off Label Use3.6%7,873
8
Dizziness3.5%7,644
9
Depression3.2%6,914
10
Pain3.0%6,541
11
Vomiting3.0%6,535
12
Dyspnoea3.0%6,501
13
Fall2.8%6,108
14
Insomnia2.6%5,657
15
Malaise2.5%5,416

These are voluntary reports and do not establish that sertraline caused these reactions.

Report severity

71.8%Serious154,889 reports
31.4%Hospitalizations67,733 reports
8.7%Fatal18,769 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sertraline drug interactions

Other drugs that appear in adverse event reports alongside sertraline. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Quetiapine-fumarate4.2%9,013
2
Adalimumab2.8%6,130
3
Aripiprazole2.3%5,064
4
Olanzapine2.1%4,554
5
Acetaminophen2.1%4,487
6
Lenalidomide1.9%4,158
7
Sodium-oxybate1.9%4,019
8
Risperidone1.8%3,936
9
Pregabalin1.7%3,772
10
Bupropion1.7%3,725
11
Omeprazole1.7%3,577
12
Alprazolam1.5%3,165
13
Mirtazapine1.4%3,127
14
Venlafaxine1.4%3,000
15
Lamotrigine1.3%2,833

Taken alongside

1
Acetaminophen11.5%24,739
2
Levothyroxine-sodium9.9%21,409
3
Aspirin9.8%21,235
4
Ergocalciferol9.4%20,224
5
Omeprazole9.3%20,001
6
Atorvastatin-calcium8.4%18,078
7
Gabapentin7.8%16,761
8
Albuterol7.6%16,336
9
Furosemide6.3%13,540
10
Amlodipine6.2%13,272
11
Metoprolol5.9%12,634
12
Lisinopril5.6%12,125
13
Metformin5.6%12,075
14
Pantoprazole-sodium5.5%11,820
15
Fluticasone5.3%11,392

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sertraline side effects

61.7% of sertraline adverse event reports involve female patients and 30.2% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female61.7%
Male30.2%
Unknown8.0%

Age group

< 21.3%
2–111.0%
12–174.5%
18–6463.9%
65+29.3%

What is sertraline used for

Conditions and purposes for which patients were taking sertraline when the adverse event was reported.

AbasiaAbdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain UpperAbnormal BehaviourAbnormal DreamsAbuliaAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildActivities Of Daily Living ImpairedAcute Myeloid LeukaemiaAcute PsychosisAcute Stress Disorder

Showing 15 of 1,354 indications

Sertraline brand names and reporting trend

Sertraline is sold under the brand name Zoloft.

Brand names

Zoloft30

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sertraline with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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