SCOPOLAMINE

N/A

Manufactured by Baxter Healthcare Corporation

12,807 FDA adverse event reports analyzed

Last updated: 2026-04-15

About SCOPOLAMINE

SCOPOLAMINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Corporation. The most commonly reported adverse reactions for SCOPOLAMINE include NAUSEA, OFF LABEL USE, VOMITING, DIZZINESS, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SCOPOLAMINE.

Top Adverse Reactions

NAUSEA675 reports
OFF LABEL USE566 reports
VOMITING478 reports
DIZZINESS433 reports
HEADACHE339 reports
DRUG INEFFECTIVE315 reports
VISION BLURRED276 reports
FATIGUE273 reports
MALAISE244 reports
DEATH242 reports
CONFUSIONAL STATE239 reports
DIARRHOEA239 reports
PAIN221 reports
DRY MOUTH201 reports
MYDRIASIS200 reports
DYSPNOEA188 reports
PRODUCT QUALITY ISSUE179 reports
PRODUCT USE IN UNAPPROVED INDICATION172 reports
HALLUCINATION171 reports
ANXIETY167 reports
ASTHENIA164 reports
FALL164 reports
PNEUMONIA154 reports
FEELING ABNORMAL144 reports
PYREXIA144 reports
WEIGHT DECREASED143 reports
SOMNOLENCE135 reports
RASH132 reports
ABDOMINAL PAIN131 reports
DEHYDRATION126 reports
DECREASED APPETITE125 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION121 reports
CONSTIPATION118 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS115 reports
DISORIENTATION112 reports
HYPERSENSITIVITY111 reports
VERTIGO111 reports
URINARY TRACT INFECTION108 reports
COUGH106 reports
HYPOTENSION106 reports
CONDITION AGGRAVATED99 reports
APPLICATION SITE ERYTHEMA97 reports
WITHDRAWAL SYNDROME97 reports
PRODUCT ADHESION ISSUE96 reports
ARTHRALGIA95 reports
BALANCE DISORDER92 reports
AGITATION91 reports
ANAEMIA91 reports
PAIN IN EXTREMITY90 reports
PRURITUS90 reports
TREMOR89 reports
INSOMNIA87 reports
APPLICATION SITE PRURITUS85 reports
HYPERTENSION85 reports
TACHYCARDIA85 reports
THERAPEUTIC RESPONSE UNEXPECTED85 reports
GAIT DISTURBANCE84 reports
TOXICITY TO VARIOUS AGENTS84 reports
DRUG INTERACTION83 reports
VISUAL IMPAIRMENT83 reports
DYSPHAGIA80 reports
BACK PAIN79 reports
RENAL FAILURE77 reports
SEIZURE76 reports
CHEST PAIN75 reports
OVERDOSE75 reports
DYSPHONIA74 reports
PARAESTHESIA74 reports
THROMBOCYTOPENIA74 reports
PRODUCT USE ISSUE73 reports
ABDOMINAL PAIN UPPER72 reports
DRUG HYPERSENSITIVITY72 reports
APPLICATION SITE IRRITATION71 reports
DEPRESSION71 reports
DRUG WITHDRAWAL SYNDROME71 reports
LOSS OF CONSCIOUSNESS69 reports
MEMORY IMPAIRMENT69 reports
ACUTE KIDNEY INJURY67 reports
APPLICATION SITE RASH67 reports
SEPSIS67 reports
SWELLING FACE67 reports
AMNESIA65 reports
DRUG INTOLERANCE64 reports
NEUTROPENIA63 reports
PRODUCT DOSE OMISSION ISSUE62 reports
FEBRILE NEUTROPENIA61 reports
PLATELET COUNT DECREASED61 reports
SPEECH DISORDER61 reports
WHITE BLOOD CELL COUNT DECREASED60 reports
HYPOAESTHESIA59 reports
RESPIRATORY FAILURE59 reports
DELIRIUM58 reports
INCORRECT DRUG ADMINISTRATION DURATION58 reports
ANGIOEDEMA56 reports
HYPERHIDROSIS56 reports
MIGRAINE55 reports
HAEMOGLOBIN DECREASED54 reports
MUSCLE SPASMS54 reports
SWOLLEN TONGUE53 reports
APPLICATION SITE PAIN52 reports

Report Outcomes

Out of 5,416 classified reports for SCOPOLAMINE:

Serious 68.5%Non-Serious 31.5%

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

Female3,170 (65.2%)
Male1,676 (34.5%)
Unknown15 (0.3%)

Reports by Age

Age 4186 reports
Age 6483 reports
Age 6280 reports
Age 5873 reports
Age 5671 reports
Age 6171 reports
Age 6768 reports
Age 5265 reports
Age 6864 reports
Age 6063 reports
Age 6363 reports
Age 4962 reports
Age 6961 reports
Age 4759 reports
Age 4859 reports
Age 5759 reports
Age 5357 reports
Age 4656 reports
Age 5556 reports
Age 3255 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 SCOPOLAMINE?

This profile reflects 12,807 FDA FAERS reports that mention SCOPOLAMINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SCOPOLAMINE?

Frequently reported terms in FAERS include NAUSEA, OFF LABEL USE, VOMITING, DIZZINESS, HEADACHE, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SCOPOLAMINE?

Labeling and FAERS entries often list Baxter Healthcare Corporation in connection with SCOPOLAMINE. 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.