Reported Reactions

Drugs › Phenothiazine

Generic name

Perphenazine: adverse event reports filed with FDA

1,005 reports list it as a suspect or interacting product, 2004–2026. Class: Phenothiazine. Also reported as Perphenazine Tablets 8mg, Perphenazine Tablets 16mg, Perphenazine Tablets 2mg.

1,005
reports as suspect product
0% of all reports · about 45 a year
66
reports, 12 months to June 2026
98 in the 12 months before
91%
marked serious by the reporter
87.8% across the class
13.5%
record death among outcomes, as reported
136 reports · not verified by FDA

1,005 adverse event reports received by FDA list perphenazine, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 1,104 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 66 reports listed it, down 33% from 98 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 45 reports a year and 0% of the 20,646,523 reports in the database, and 6.4% of the reports for the phenothiazine class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded toxicity to various agents (25%), drug ineffective (23.7%) and weight increased (17.2%). A report can list several reactions, so shares add to more than 100%; 300 different terms appear across these reports. Toxicity to various agents is recorded in 25% of these reports, a larger share than in the median phenothiazine drug (9.4%).

91% of the reports are marked serious by the reporter (87.8% across the class); 13.5% record death among the outcomes and 57.2% record hospitalisation, as reported. 43.5% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (28.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

01530Jul 2021: 1Aug 2021: 2Sep 2021: 4Oct 2021: 7Nov 2021: 2Dec 2021: 82022Jan 2022: 8Feb 2022: 3Mar 2022: 4Apr 2022: 5May 2022: 7Jun 2022: 11Jul 2022: 6Aug 2022: 13Sep 2022: 3Oct 2022: 4Nov 2022: 9Dec 2022: 52023Jan 2023: 3Feb 2023: 1Mar 2023: 1Apr 2023: 6May 2023: 7Jun 2023: 14Jul 2023: 8Aug 2023: 10Sep 2023: 4Oct 2023: 9Nov 2023: 7Dec 2023: 92024Jan 2024: 10Feb 2024: 12Mar 2024: 7Apr 2024: 8May 2024: 5Jun 2024: 1Jul 2024: 3Aug 2024: 9Sep 2024: 1Oct 2024: 1Nov 2024: 4Dec 2024: 262025Jan 2025: 30Feb 2025: 5Mar 2025: 10Apr 2025: 6May 2025: 1Jun 2025: 2Jul 2025: 10Aug 2025: 8Sep 2025: 8Oct 2025: 3Nov 2025: 4Dec 2025: 92026Jan 2026: 5Feb 2026: 3Mar 2026: 3Apr 2026: 1May 2026: 1Jun 2026: 11

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

048962004: 1920042005: 52006: 102007: 2020072008: 172009: 252010: 2620102011: 292012: 332013: 3520132014: 402015: 272016: 4120162017: 422018: 432019: 6920192020: 862021: 742022: 7820222023: 792024: 872025: 9620252026: 24

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Perphenazine reports recording the termmedian drug in phenothiazine

  1. Toxicity to various agentspoisoning or toxic effect of one or more substances25%251
  2. Drug ineffectivethe medicine did not work as expected23.7%238
  3. Weight increasedweight gain17.2%173
  4. Akathisiainner restlessness and an urge to move16.8%169
  5. Suicide attempta suicide attempt15.3%154
  6. Antipsychotic drug level below therapeutic14.7%148
  7. Disinhibition14.7%148
  8. Product use in unapproved indicationused for a purpose not on the label13.9%140
  9. Therapeutic product effect variable13.9%140
  10. Leukopenialow white blood cells12.7%128
  11. Off label useused for a purpose or in a way not on the label12.5%126
  12. Drug interactionan interaction between medicines8.6%86
  13. Tardive dyskinesiainvoluntary repetitive movements8.4%84
  14. Leukaemia8.3%83
  15. Dystoniainvoluntary muscle contractions7.7%77
  16. Hypertensionhigh blood pressure7.7%77
  17. Completed suicidedeath by suicide7.6%76
  18. Dyskinesiainvoluntary movements7.5%75
  19. Obesity7.3%73
  20. Falla fall6.9%69
  21. Hypotensionlow blood pressure6.2%62
  22. Myoclonus5.9%59
  23. Dyspnoeashortness of breath5.4%54

Top 30 of 300 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the phenothiazine class; it describes the reports, not the patients. 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."

Outcomes recorded

Death13.5%136
Life-threatening9.8%98
Hospitalisation (initial or prolonged)57.2%575
Disability4.1%41
Congenital anomaly1%10
Other serious61.9%622
Not serious9%90

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 15,718 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20.7%7
2 to 110.3%3
12 to 171.8%18
18 to 4428.4%285
45 to 6424%241
65 to 745.5%55
75 and over8.7%87
Age not given30.7%309

Patient sex

Female48.3%485
Male40.5%407
Not given11.2%113

Who reported

Physician31.7%319
Pharmacist6%60
Other health professional43.5%437
Lawyer0.2%2
Consumer or non-health professional14.2%143
Not given4.4%44

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 40.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Schizophrenia20920.8%
Schizoaffective disorder818.1%
Insomnia515.1%
Psychotic disorder333.3%
Bipolar disorder222.2%
Depression202%

The indication field is filled in by the reporter and is often blank; shares are of all 1,005 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Perphenazine reports
Olanzapine32232%
Clozapine30029.9%
Risperidone24023.9%
Aripiprazole23823.7%
Quetiapine22822.7%
Haloperidol22622.5%
Lithium carbonate16516.4%
Amisulpride16116%
Clomipramine16116%
Gabapentin15315.2%

Other products listed in reports where Perphenazine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasurePerphenazinePhenothiazineAll reports
Reports as suspect product1,00515,71820,646,523
Share of that pool—6.4%0%
Reports, latest 12 months66—1,332,454
Marked serious91%87.8%57.4%
Death recorded among outcomes, per 1,000 reports13525291
Hospitalisation recorded, per 1,000 reports572379213
Consumer-filed share14.2%16.6%45.8%
Top term, share of reportsToxicity to various agents 25%median 9.4%0.8%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the phenothiazine class

DrugName typeReportsLatest 12 monthsMarked serious
Promethazinegeneric5,50326492.7%
Chlorpromazinegeneric3,37222597.3%
Prochlorperazinegeneric1,79815885.5%
Phenerganbrand1,4963164.6%
Promethazine hydrochloridegeneric1,17611783.1%
Chlorpromazine hydrochloridegeneric8433091.9%
Promethazine hclgeneric525046.3%

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." A brand and its generic are separate rows because reporters name them separately.

Questions about Perphenazine reports

How many adverse event reports has FDA received for Perphenazine?

1,005 reports list Perphenazine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 66 of them arrived in the latest 12 months. Another 1,104 list it only as a concomitant medication.

What reactions are recorded in Perphenazine reports?

toxicity to various agents (25%), drug ineffective (23.7%), weight increased (17.2%), akathisia (16.8%) and suicide attempt (15.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Perphenazine was responsible.

How serious are the reports?

91% are marked serious by the reporter. Among the outcomes recorded, 13.5% of reports include death and 57.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

other health professional (43.5%), physician (31.7%) and consumer or non-health professional (14.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Perphenazine rising?

66 reports in the 12 months to June 2026, down 33% from 98 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Perphenazine was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Perphenazine?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Perphenazine as a suspect or interacting product; reports listing it only as a concomitant medication (1,104) are excluded. 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.