Pharmacologic class (EPC) · 8 drug pages

Phenothiazine: adverse event reports filed with FDA

15,718 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.

15,718
reports across the class: 0.1% of all reports; 891
reports, 12 months to June 2026: 1,110 in the 12 months before; 87.8%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Phenothiazine is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 15,718 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

891 reports arrived in the 12 months to June 2026, down 20% from 1,110 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 87.8% of the class's reports are marked serious, 25.2% record death among the outcomes and 37.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are toxicity to various agents (12.4%), drug ineffective (7.9%) and completed suicide (6.8%). 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
Promethazine	generic	5,503	264	92.7%	Toxicity to various agents
Chlorpromazine	generic	3,372	225	97.3%	Drug ineffective
Prochlorperazine	generic	1,798	158	85.5%	Nausea
PhenerganPromethazine hydrochloride	brand	1,496	31	64.6%	Drug hypersensitivity
Promethazine hydrochloride	generic	1,176	117	83.1%	Toxicity to various agents
Perphenazine	generic	1,005	66	91%	Toxicity to various agents
Chlorpromazine hydrochloride	generic	843	30	91.9%	Toxicity to various agents
Promethazine hcl	generic	525	0	46.3%	Drug hypersensitivity

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

Toxicity to various agentspoisoning or toxic effect of one or more substances12.4%1,951
Drug ineffectivethe medicine did not work as expected7.9%1,235
Completed suicidedeath by suicide6.8%1,076
Nauseafeeling sick6.5%1,020
Drug hypersensitivityan allergic-type reaction to a medicine5.9%931
Drug abusemisuse of a medicine5.5%858
Drug interactionan interaction between medicines5.2%819
Off label useused for a purpose or in a way not on the label4.9%775
Vomitingbeing sick4.9%774
Overdosea dose above the recommended amount4.4%692
Intentional overdosea deliberate overdose3.9%617
Fatiguetiredness3.8%598
Somnolencedrowsiness3.5%548
Suicide attempta suicide attempt3.5%545
Confusional stateconfusion3.4%542
Anxietyanxiety3.4%540
Deaththe patient died; cause not stated by this term3%466
Painpain, site not specified2.9%457
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity2.7%421
Pneumonialung infection2.6%415
Falla fall2.6%413
Dyspnoeashortness of breath2.6%401
Cardiac arrestthe heart stopped2.5%400
Headachehead pain2.5%395
Diarrhoealoose or frequent stools2.5%392

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death25.2%3,967

Life-threatening9.5%1,499

Hospitalisation (initial or prolonged)37.9%5,952

Disability3.1%486

Congenital anomaly1.6%257

Other serious49.9%7,849

Not serious12.2%1,920

Patient age

Under 21.5%233

2 to 111.2%193

12 to 173.4%540

18 to 4432%5,029

45 to 6424.7%3,879

65 to 747.9%1,239

75 and over5%782

Age not given24.3%3,823

Who reported

Physician30.7%4,829

Pharmacist11.8%1,852

Other health professional36%5,665

Lawyer0.5%72

Consumer or non-health professional16.6%2,606

Not given4.4%694

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 Phenothiazine reports

Which drugs are in the Phenothiazine class on this site?

Promethazine, Chlorpromazine, Prochlorperazine, Phenergan, Promethazine hydrochloride and Perphenazine and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

15,718 reports through June 2026, 891 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?

toxicity to various agents (12.4%), drug ineffective (7.9%), completed suicide (6.8%), nausea (6.5%) and drug hypersensitivity (5.9%).

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.