Benztropine: adverse event reports filed with FDA

1,492

reports as suspect product

0% of all reports · about 70 a year

167

reports, 12 months to June 2026

87 in the 12 months before

94.2%

marked serious by the reporter

39.6% across the class

45.4%

record death among outcomes, as reported

678 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 Benztropine reports recording the termmedian drug in anticholinergic

1. Completed suicidedeath by suicide22.7%338
2. Toxicity to various agentspoisoning or toxic effect of one or more substances20.7%309
3. Drug ineffectivethe medicine did not work as expected8.3%124
4. Drug interactionan interaction between medicines8.2%122
5. Deaththe patient died; cause not stated by this term6.3%94
6. Drug abusemisuse of a medicine5.9%88
7. Off label useused for a purpose or in a way not on the label5.7%85
8. Cardiac arrestthe heart stopped4.3%64
9. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor4%60
10. Cardio-respiratory arrestthe heart and breathing stopped3.5%52
11. Tremorshaking3.5%52
12. Confusional stateconfusion3.2%48
13. Agitationrestlessness2.9%44
14. Extrapyramidal disordermovement problems such as stiffness or tremor2.9%44
15. Condition aggravatedthe condition being treated got worse2.7%41
16. Dystoniainvoluntary muscle contractions2.5%37
17. Deliriumsudden confusion2.3%35
18. Suspected suicide2.3%34
19. Tardive dyskinesiainvoluntary repetitive movements2.2%33
20. Intentional overdosea deliberate overdose2.1%32
21. Constipationconstipation2.1%31
22. Product use in unapproved indicationused for a purpose not on the label2.1%31
23. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity1.9%28
24. Tachycardiafast heart rate1.9%28
25. Psychotic disordera loss of contact with reality1.8%27
26. Respiratory arrestbreathing stopped1.8%27
27. Falla fall1.7%26
28. Anxietyanxiety1.7%25
29. Sedationdrowsiness from a medicine1.7%25
30. Weight increasedweight gain1.6%24

Top 30 of 379 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 24 drugs in the anticholinergic 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 159,807 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. 76.4% 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 1,492 reports.

Drugs most often listed in the same reports

Other products listed in reports where Benztropine 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 anticholinergic 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 Benztropine as a suspect or interacting product; reports listing it only as a concomitant medication (3,375) 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.