Product name as reported
Trevicta: adverse event reports filed with FDA
543 reports list it as a suspect or interacting product, 2016–2021.
- 543
- reports as suspect product
- 0% of all reports · about 55 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 96.5%
- marked serious by the reporter
- 57.4% across all reports
- 11.6%
- record death among outcomes, as reported
- 63 reports · not verified by FDA
Between August 2016 and September 2021, 543 adverse event reports received by FDA list the product name "Trevicta" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (20) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, and none 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 55 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (12%), condition aggravated (9%) and drug ineffective (6.6%). A report can list several reactions, so shares add to more than 100%; 139 different terms appear across these reports. Off label use is recorded in 12% of these reports, against 4.1% of all reports in the database.
96.5% of the reports are marked serious by the reporter; 11.6% record death among the outcomes and 49% record hospitalisation, as reported. 53.6% of the reports came from physicians, and the largest patient age group is 18 to 44 (35.7%). 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
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
Reactions recorded in the reports
share of Trevicta reports recording the termall reports in the database
- Off label useused for a purpose or in a way not on the label12%65
- Condition aggravatedthe condition being treated got worse9%49
- Drug ineffectivethe medicine did not work as expected6.6%36
- Hospitalisationadmission to hospital5.7%31
- Deaththe patient died; cause not stated by this term5.5%30
- Psychotic disordera loss of contact with reality5.2%28
- Schizophreniaschizophrenia5%27
- Deliriumsudden confusion4.4%24
- Product use in unapproved indicationused for a purpose not on the label4.2%23
- Psychotic symptom3.9%21
- Delusiona fixed false belief3.7%20
- Malaisegeneral feeling of being unwell3.3%18
- Anxietyanxiety2.8%15
- Psychiatric decompensation2.4%13
- Aggressionaggressive behaviour2.2%12
- Pulmonary embolisma blood clot in the lung2.2%12
- Suicidal ideationthoughts of suicide2%11
- Underdoseless than the intended dose2%11
- Weight increasedweight gain2%11
- Abnormal behaviourunusual behaviour1.8%10
- Dyspnoeashortness of breath1.8%10
- Hallucination, auditory1.8%10
- Suicide attempta suicide attempt1.8%10
- Inappropriate schedule of product administrationthe product was taken at the wrong times1.7%9
- Amenorrhoeaperiods stopped1.5%8
- Completed suicidedeath by suicide1.5%8
- Depressionlow mood1.3%7
- Drug abusemisuse of a medicine1.3%7
- Hallucinationseeing or hearing things that are not there1.3%7
- Dermatitis bullous1.1%6
Top 30 of 139 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 share of all reports in the database; 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
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 20,646,523 reports. 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
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 0.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Schizophrenia | 183 | 33.7% |
| Psychotic disorder | 16 | 2.9% |
| Schizoaffective disorder | 10 | 1.8% |
| Bipolar disorder | 9 | 1.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 543 reports.
In context
| Measure | Trevicta | All reports |
|---|---|---|
| Reports as suspect product | 543 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 0 | 1,332,454 |
| Marked serious | 96.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 116 | 91 |
| Hospitalisation recorded, per 1,000 reports | 490 | 213 |
| Consumer-filed share | 25.8% | 45.8% |
| Top term, share of reports | Off label use 12% | 4.1% |
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."
Questions about Trevicta reports
How many adverse event reports has FDA received for Trevicta?
543 reports list Trevicta as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 20 list it only as a concomitant medication.
What reactions are recorded in Trevicta reports?
off label use (12%), condition aggravated (9%), drug ineffective (6.6%), hospitalisation (5.7%) and death (5.5%). 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 Trevicta was responsible.
How serious are the reports?
96.5% are marked serious by the reporter. Among the outcomes recorded, 11.6% of reports include death and 49% 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?
physician (53.6%), consumer or non-health professional (25.8%) and other health professional (12.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Trevicta rising?
0 reports in the 12 months to June 2026, and none 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 Trevicta 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 Trevicta?
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 Trevicta as a suspect or interacting product; reports listing it only as a concomitant medication (20) 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.