Pharmacologic class (EPC) · 21 drug pages

Serotonin reuptake inhibitor: adverse event reports filed with FDA

273,115 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

273,115
reports across the class: 1.3% of all reports; 13,797
reports, 12 months to June 2026: 15,819 in the 12 months before; 83.7%
marked serious by the reporter: 57.4% across all reports; 21
drugs with a page: brand and generic names counted separately

Serotonin reuptake inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 21 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 273,115 adverse event reports received by FDA, 1.3% of the database, from January 2004 to June 2026.

13,797 reports arrived in the 12 months to June 2026, down 13% from 15,819 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 83.7% of the class's reports are marked serious, 15.9% record death among the outcomes and 32.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (7.5%), drug interaction (7.1%) and toxicity to various agents (6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Sertraline	generic	44,814	3,714	93%	Drug interaction
Citalopram	generic	30,414	1,169	95.2%	Toxicity to various agents
Fluoxetine	generic	28,319	1,734	93%	Toxicity to various agents
PaxilParoxetine hydrochloride	brand	24,193	56	57%	Drug withdrawal syndrome
Escitalopram	generic	24,176	1,839	92.5%	Drug interaction
ZoloftSertraline hydrochloride	brand	21,311	295	65.5%	Drug ineffective
Paroxetine	generic	16,204	1,170	93%	Drug interaction
ProzacFluoxetine hydrochloride	brand	11,547	276	69.5%	Foetal exposure during pregnancy
Sertraline hydrochloride	generic	11,077	1,080	85.2%	Drug interaction
Citalopram hydrobromide	generic	10,675	234	96.4%	Completed suicide
LexaproEscitalopram	brand	9,424	318	64.4%	Drug ineffective
Paroxetine hydrochloride	generic	8,935	268	84.2%	Suicidal ideation
Sertraline hcl	generic	7,592	0	67.7%	Drug ineffective
Fluoxetine hydrochloride	generic	6,209	648	91.9%	Drug interaction
Escitalopram oxalate	generic	5,063	399	92.8%	Drug ineffective
Trazodone hydrochloride	generic	4,213	364	82.2%	Drug ineffective
CelexaCitalopram	brand	3,626	61	61.7%	Drug ineffective
Trazodone hcl	generic	2,489	17	84.1%	Completed suicide
Fluvoxamine maleate	generic	1,174	151	79.4%	Drug interaction
Fluoxetine hcl	generic	1,013	4	90.7%	Drug interaction
BrisdelleParoxetine	brand	647	0	4.2%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected7.5%20,516
Drug interactionan interaction between medicines7.1%19,472
Toxicity to various agentspoisoning or toxic effect of one or more substances6%16,487
Completed suicidedeath by suicide6%16,379
Anxietyanxiety5.5%14,947
Nauseafeeling sick5.1%13,822
Dizzinesslight-headedness or unsteadiness4.7%12,871
Depressionlow mood4.6%12,628
Headachehead pain4.5%12,302
Suicidal ideationthoughts of suicide4.3%11,754
Fatiguetiredness4.3%11,634
Insomniadifficulty sleeping4%10,929
Suicide attempta suicide attempt3.7%10,018
Intentional overdosea deliberate overdose3.5%9,657
Somnolencedrowsiness3.5%9,646
Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.5%9,621
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3.5%9,620
Tremorshaking3.5%9,493
Drug abusemisuse of a medicine3.3%9,134
Vomitingbeing sick3.2%8,829
Diarrhoealoose or frequent stools3.1%8,349
Confusional stateconfusion3%8,288
Off label useused for a purpose or in a way not on the label3%8,147
Overdosea dose above the recommended amount2.8%7,761
Drug withdrawal syndromesymptoms on stopping a medicine2.7%7,441

Solid bar: share of all class reports. Hollow bar: the median share across the 21 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.9%43,527

Life-threatening7.5%20,366

Hospitalisation (initial or prolonged)32.1%87,726

Disability4.9%13,492

Congenital anomaly5.2%14,336

Other serious51%139,422

Not serious16.3%44,441

Patient age

Under 21.8%4,875

2 to 110.7%1,926

12 to 174.1%11,081

18 to 4426.2%71,489

45 to 6420.9%57,179

65 to 747%19,153

75 and over8.1%22,049

Age not given31.3%85,363

Who reported

Physician26.3%71,807

Pharmacist8.5%23,343

Other health professional27.1%73,955

Lawyer2.3%6,248

Consumer or non-health professional30.8%84,025

Not given5%13,737

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Serotonin reuptake inhibitor reports

Which drugs are in the Serotonin reuptake inhibitor class on this site?

Sertraline, Citalopram, Fluoxetine, Paxil, Escitalopram and Zoloft and 15 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

273,115 reports through June 2026, 13,797 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (7.5%), drug interaction (7.1%), toxicity to various agents (6%), completed suicide (6%) and anxiety (5.5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.