What the label lists and what reports show
Benztropine side effects
Benztropine's FDA label lists its adverse reactions in its own words. FAERS holds 7,287 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is toxicity to various agents (403 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the benztropine FDA label on DailyMed (effective January 9, 2026, ScieGen Pharmaceuticals Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity. Cardiovascular Tachycardia. Digestive Paralytic ileus, constipation, vomiting, nausea, dry mouth. If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage, or discontinue the drug temporarily. Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage. Nervous System Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations; exacerbation of pre-existing psychotic symptoms; nervousness; depression; listlessness; numbness of fingers. Special Senses Blurred vision, dilated pupils. …
Source: FDA drug label, ScieGen Pharmaceuticals Inc, effective January 9, 2026 (SPL set 1ead16a7-88ed-407d-b25a-0d9a1d9da5ef), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,287 reports list benztropine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,347 are coded as a death and 2,706 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Benztropine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions