BENZTROPINE MESYLATE

N/A

Manufactured by Chartwell RX, LLC.

5,542 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BENZTROPINE MESYLATE

BENZTROPINE MESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell RX, LLC.. The most commonly reported adverse reactions for BENZTROPINE MESYLATE include GRANULOCYTOPENIA, COMPLETED SUICIDE, TREMOR, DEATH, DIABETES MELLITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENZTROPINE MESYLATE.

Top Adverse Reactions

GRANULOCYTOPENIA152 reports
COMPLETED SUICIDE129 reports
TREMOR125 reports
DEATH120 reports
DIABETES MELLITUS120 reports
DRUG INTERACTION118 reports
DRUG INEFFECTIVE116 reports
WEIGHT INCREASED109 reports
CONFUSIONAL STATE104 reports
CONSTIPATION97 reports
NAUSEA94 reports
TYPE 2 DIABETES MELLITUS94 reports
FATIGUE90 reports
ANXIETY85 reports
DEPRESSION85 reports
DIZZINESS80 reports
SOMNOLENCE78 reports
DYSPNOEA77 reports
OFF LABEL USE76 reports
OVERDOSE76 reports
HEADACHE75 reports
VOMITING74 reports
INSOMNIA72 reports
FALL71 reports
CONDITION AGGRAVATED67 reports
HYPERTENSION67 reports
DIARRHOEA66 reports
PYREXIA66 reports
PAIN64 reports
TARDIVE DYSKINESIA61 reports
TOXICITY TO VARIOUS AGENTS61 reports
LEUKOPENIA60 reports
PNEUMONIA60 reports
ASTHENIA57 reports
PSYCHOTIC DISORDER56 reports
TACHYCARDIA54 reports
GAIT DISTURBANCE53 reports
CHEST PAIN52 reports
SUICIDAL IDEATION52 reports
DYSTONIA50 reports
AGITATION49 reports
MENTAL DISORDER49 reports
BLOOD CHOLESTEROL INCREASED48 reports
TREATMENT NONCOMPLIANCE48 reports
WEIGHT DECREASED48 reports
HYPOTENSION47 reports
HYPOAESTHESIA46 reports
SLEEP DISORDER46 reports
SEDATION45 reports
AGGRESSION44 reports
MEMORY IMPAIRMENT44 reports
RASH44 reports
CARDIAC ARREST43 reports
DYSKINESIA43 reports
MALAISE43 reports
VISION BLURRED43 reports
SCHIZOPHRENIA42 reports
URINARY TRACT INFECTION42 reports
DRY MOUTH41 reports
FOETAL EXPOSURE DURING PREGNANCY41 reports
LOSS OF CONSCIOUSNESS41 reports
TRISMUS41 reports
HYPERGLYCAEMIA40 reports
BLOOD TRIGLYCERIDES INCREASED39 reports
CONVULSION39 reports
EXTRAPYRAMIDAL DISORDER39 reports
HYPERLIPIDAEMIA39 reports
NEUROLEPTIC MALIGNANT SYNDROME39 reports
PRODUCT USE IN UNAPPROVED INDICATION39 reports
RENAL FAILURE39 reports
PAIN IN EXTREMITY37 reports
PRODUCT DOSE OMISSION ISSUE37 reports
ABNORMAL BEHAVIOUR36 reports
PREMATURE BABY36 reports
WHITE BLOOD CELL COUNT INCREASED36 reports
ARTHRALGIA35 reports
HALLUCINATION, AUDITORY35 reports
WHITE BLOOD CELL COUNT DECREASED35 reports
DIABETIC KETOACIDOSIS34 reports
DRUG WITHDRAWAL SYNDROME NEONATAL34 reports
DYSARTHRIA34 reports
DYSPHAGIA34 reports
ELECTROCARDIOGRAM QT PROLONGED33 reports
HALLUCINATION33 reports
SINUS TACHYCARDIA33 reports
BLOOD GLUCOSE INCREASED32 reports
FEELING ABNORMAL32 reports
GASTROOESOPHAGEAL REFLUX DISEASE32 reports
MUSCULOSKELETAL STIFFNESS32 reports
PANCREATITIS32 reports
ABDOMINAL PAIN31 reports
COUGH31 reports
CRYING31 reports
DEHYDRATION31 reports
DELIRIUM31 reports
MYOCARDIAL INFARCTION31 reports
NEUTROPENIA31 reports
OBESITY30 reports
PARANOIA30 reports
ASPARTATE AMINOTRANSFERASE INCREASED29 reports

Report Outcomes

Out of 2,612 classified reports for BENZTROPINE MESYLATE:

Serious 74.6%Non-Serious 25.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male1,251 (52.2%)
Female1,133 (47.2%)
Unknown14 (0.6%)

Reports by Age

Age 3566 reports
Age 4948 reports
Age 4347 reports
Age 4245 reports
Age 4842 reports
Age 5041 reports
Age 5141 reports
Age 5841 reports
Age 5540 reports
Age 4439 reports
Age 5239 reports
Age 3438 reports
Age 5637 reports
Age 5937 reports
Age 4636 reports
Age 6036 reports
Age 3733 reports
Age 2232 reports
Age 2732 reports
Age 3232 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BENZTROPINE MESYLATE?

This profile reflects 5,542 FDA FAERS reports that mention BENZTROPINE MESYLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENZTROPINE MESYLATE?

Frequently reported terms in FAERS include GRANULOCYTOPENIA, COMPLETED SUICIDE, TREMOR, DEATH, DIABETES MELLITUS, DRUG INTERACTION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BENZTROPINE MESYLATE?

Labeling and FAERS entries often list Chartwell RX, LLC. in connection with BENZTROPINE MESYLATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.