Pharmacologic class (EPC) · 3 drug pages

Typical antipsychotic: adverse event reports filed with FDA

16,422 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.

16,422
reports across the class: 0.1% of all reports; 938
reports, 12 months to June 2026: 947 in the 12 months before; 92.3%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Typical antipsychotic is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 16,422 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

938 reports arrived in the 12 months to June 2026, close to the 947 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 92.3% of the class's reports are marked serious, 13.2% record death among the outcomes and 46.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (11.6%), neuroleptic malignant syndrome (9.8%) and drug interaction (8%). 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
Haloperidol	generic	14,280	819	94.7%	Drug ineffective
Haloperidol decanoate	generic	1,317	93	86.9%	Weight increased
Haldol DecanoateHaloperidol decanoate	brand	825	26	60%	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 expected11.6%1,911
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity9.8%1,605
Drug interactionan interaction between medicines8%1,310
Extrapyramidal disordermovement problems such as stiffness or tremor7.9%1,295
Weight increasedweight gain7.8%1,281
Off label useused for a purpose or in a way not on the label7%1,156
Toxicity to various agentspoisoning or toxic effect of one or more substances5.4%893
Akathisiainner restlessness and an urge to move4.1%677
Dystoniainvoluntary muscle contractions3.8%626
Tremorshaking3.7%607
Agitationrestlessness3.6%592
Somnolencedrowsiness3.5%580
Suicide attempta suicide attempt3.5%568
Condition aggravatedthe condition being treated got worse3.5%567
Electrocardiogram QT prolongeda QT prolongation on the ECG3.4%563
Sedationdrowsiness from a medicine3.2%533
Pyrexiafever2.8%455
Deliriumsudden confusion2.8%454
Product use in unapproved indicationused for a purpose not on the label2.7%451
Completed suicidedeath by suicide2.6%422
Confusional stateconfusion2.5%414
Psychotic disordera loss of contact with reality2.5%414
Tachycardiafast heart rate2.5%413
Catatonia2.5%405
Parkinsonism2.5%405

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death13.2%2,170

Life-threatening10.9%1,785

Hospitalisation (initial or prolonged)46.1%7,574

Disability2.8%455

Congenital anomaly0.8%133

Other serious60%9,858

Not serious7.7%1,262

Patient age

Under 20.4%58

2 to 111.3%215

12 to 173.7%607

18 to 4434.4%5,657

45 to 6422.2%3,648

65 to 747.3%1,193

75 and over6.9%1,134

Age not given23.8%3,910

Who reported

Physician35.9%5,889

Pharmacist9.2%1,503

Other health professional40.5%6,644

Lawyer0.2%36

Consumer or non-health professional11.4%1,880

Not given2.9%470

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 Typical antipsychotic reports

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

Haloperidol, Haloperidol decanoate and Haldol Decanoate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

16,422 reports through June 2026, 938 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 (11.6%), neuroleptic malignant syndrome (9.8%), drug interaction (8%), extrapyramidal disorder (7.9%) and weight increased (7.8%).

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.