Pharmacologic class (EPC) · 37 drug pages

Atypical antipsychotic: adverse event reports filed with FDA

683,680 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.

683,680
reports across the class: 3.3% of all reports; 41,989
reports, 12 months to June 2026: 47,973 in the 12 months before; 70.7%
marked serious by the reporter: 57.4% across all reports; 37
drugs with a page: brand and generic names counted separately

Atypical antipsychotic is a pharmacologic class (an FDA Established Pharmacologic Class) with 37 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 683,680 adverse event reports received by FDA, 3.3% of the database, from January 2004 to June 2026.

41,989 reports arrived in the 12 months to June 2026, down 12% from 47,973 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 70.7% of the class's reports are marked serious, 12.1% record death among the outcomes and 30.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (6.9%), drug ineffective (6.8%) and gynaecomastia (5.9%). 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
Clozapine	generic	73,023	3,252	93.4%	Neutropenia
AbilifyAripiprazole	brand	54,645	625	58%	Weight increased
Risperdal	generic	54,454	882	48.4%	Gynaecomastia
NuplazidPimavanserin tartrate	brand	53,753	9,602	50.6%	Hallucination
Quetiapine	generic	52,388	4,190	97.6%	Toxicity to various agents
SeroquelQuetiapine	brand	52,272	265	62.9%	Diabetes mellitus
ClozarilClozapine	brand	47,914	3,088	98.4%	Death
Olanzapine	generic	46,837	4,087	95.3%	Drug ineffective
Risperidone	generic	44,962	2,511	76.9%	Gynaecomastia
Aripiprazole	generic	30,145	3,102	87.8%	Drug ineffective
ZyprexaOlanzapine	brand	26,469	121	78.4%	Diabetes mellitus
Invega SustennaPaliperidone palmitate	brand	23,648	1,513	35.8%	Off label use
Quetiapine fumarate	generic	19,568	1,697	90.7%	Drug ineffective
InvegaPaliperidone	brand	16,672	238	35.5%	Injury
LatudaLurasidone hydrochloride	brand	16,085	183	40.7%	Off label use
RexultiBrexpiprazole	brand	12,683	630	32.3%	Weight increased
GeodonZiprasidone	brand	8,566	40	67%	Drug ineffective
CaplytaLumateperone	brand	6,616	2,044	26.8%	Dizziness
SaphrisAsenapine maleate	brand	6,496	26	39.3%	Drug ineffective
VraylarCariprazine	brand	6,176	822	23.1%	Off label use
AristadaAripiprazole lauroxil	brand	4,352	274	16.2%	Off label use
Invega TrinzaPaliperidone palmitate	brand	4,345	205	37.4%	Off label use
Paliperidone	generic	3,670	402	93.2%	Drug ineffective
Paliperidone palmitate	generic	2,899	307	95.6%	Hospitalisation
Ziprasidone	generic	2,434	141	89.6%	Drug ineffective
Brexpiprazole	generic	1,648	553	87.1%	Death
LybalviOlanzapine and samidorphan l-malate	brand	1,513	303	21%	Off label use
Risperdal M-TabRisperidone	brand	1,461	4	23.6%	Gynaecomastia
FanaptIloperidone	brand	1,157	84	44%	Dizziness
UzedyRisperidone	brand	1,141	400	33.8%	Off label use
Ziprasidone hydrochloride	generic	1,010	19	92.5%	Drug ineffective
Ziprasidone hcl	generic	931	0	73%	Completed suicide
Lurasidone hydrochloride	generic	860	83	82.6%	Drug ineffective
Zyprexa ZydisOlanzapine	brand	820	7	71%	Weight increased
Cariprazine	generic	795	177	84%	Drug ineffective
Invega HafyeraPaliperidone palmitate	brand	650	80	29.1%	Drug ineffective
Asenapine	generic	622	32	82%	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

Off label useused for a purpose or in a way not on the label6.9%46,852
Drug ineffectivethe medicine did not work as expected6.8%46,255
Gynaecomastiabreast enlargement in men5.9%40,433
Weight increasedweight gain5.5%37,433
Deaththe patient died; cause not stated by this term4.6%31,480
Neutropenialow neutrophils, a type of white blood cell3.4%23,358
Somnolencedrowsiness3.4%23,277
Drug interactionan interaction between medicines3.3%22,307
Hallucinationseeing or hearing things that are not there3%20,209
Product use in unapproved indicationused for a purpose not on the label2.9%20,069
Toxicity to various agentspoisoning or toxic effect of one or more substances2.9%19,713
Suicide attempta suicide attempt2.8%19,236
Insomniadifficulty sleeping2.7%18,787
Hospitalisationadmission to hospital2.7%18,450
Anxietyanxiety2.7%18,333
Condition aggravatedthe condition being treated got worse2.6%18,021
Sedationdrowsiness from a medicine2.4%16,180
Confusional stateconfusion2.3%16,036
Fatiguetiredness2.3%15,787
Diabetes mellitusdiabetes2.2%15,334
Schizophreniaschizophrenia2.2%15,125
Tremorshaking2.2%15,075
Abnormal weight gain2.2%15,016
Depressionlow mood2.2%14,902
Falla fall2.2%14,886

Solid bar: share of all class reports. Hollow bar: the median share across the 37 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death12.1%82,867

Life-threatening5%34,415

Hospitalisation (initial or prolonged)30.4%207,525

Disability2.4%16,703

Congenital anomaly0.7%4,455

Other serious45.8%313,124

Not serious29.3%200,405

Patient age

Under 20.5%3,358

2 to 111.6%11,200

12 to 173.2%21,805

18 to 4424.1%164,575

45 to 6417.4%119,267

65 to 745.7%39,187

75 and over6.1%41,425

Age not given41.4%282,863

Who reported

Physician26.6%181,701

Pharmacist7.7%52,914

Other health professional25.7%175,867

Lawyer2.1%14,095

Consumer or non-health professional34%232,709

Not given3.9%26,394

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 Atypical antipsychotic reports

Which drugs are in the Atypical antipsychotic class on this site?

Clozapine, Abilify, Risperdal, Nuplazid, Quetiapine and Seroquel and 31 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

683,680 reports through June 2026, 41,989 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?

off label use (6.9%), drug ineffective (6.8%), gynaecomastia (5.9%), weight increased (5.5%) and death (4.6%).

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.