Ingrezza: adverse event reports filed with FDA

24,265

reports as suspect product

0.1% of all reports · about 2,673 a year

1,137

reports, 12 months to June 2026

1,000 in the 12 months before

22.6%

marked serious by the reporter

30.3% across the class

5%

record death among outcomes, as reported

1,224 reports · not verified by FDA

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

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Ingrezza reports recording the termmedian drug in vesicular monoamine transporter 2 inhibitor

1. Drug ineffectivethe medicine did not work as expected11.3%2,731
2. Somnolencedrowsiness10%2,431
3. Fatiguetiredness6.8%1,660
4. Tremorshaking6.4%1,554
5. Tardive dyskinesiainvoluntary repetitive movements5.7%1,382
6. Falla fall4.5%1,099
7. Dizzinesslight-headedness or unsteadiness3.9%938
8. Deaththe patient died; cause not stated by this term3.8%914
9. Drooling3.7%900
10. Therapeutic product effect decreased3.6%876
11. Dyskinesiainvoluntary movements3.5%852
12. Anxietyanxiety2.7%653
13. Off label useused for a purpose or in a way not on the label2.6%641
14. Hospitalisationadmission to hospital2.6%640
15. Nauseafeeling sick2.5%613
16. Parkinsonism2.5%608
17. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine2.3%568
18. Insomniadifficulty sleeping2.3%554
19. Therapeutic product effect incomplete2.3%548
20. Balance disorderproblems with balance2.3%547
21. Feeling abnormalfeeling odd or not right1.9%462
22. Depressionlow mood1.9%459
23. Gait disturbancedifficulty walking1.9%454
24. Restlessnessrestlessness1.9%453
25. Headachehead pain1.8%442
26. Sedationdrowsiness from a medicine1.7%423
27. Astheniaweakness or lack of energy1.6%385
28. Rashskin rash1.5%364
29. Urticariahives1.5%360
30. Vomitingbeing sick1.4%335

Top 30 of 817 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 3 drugs in the vesicular monoamine transporter 2 inhibitor 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

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 31,545 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 24,265 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ingrezza 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

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 vesicular monoamine transporter 2 inhibitor class

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.

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 Ingrezza as a suspect or interacting product; reports listing it only as a concomitant medication (340) 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.