BOTULINUM TOXIN TYPE A

N/A

Manufactured by Galderma Laboratories, L.P.

74,480 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BOTULINUM TOXIN TYPE A

BOTULINUM TOXIN TYPE A is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Galderma Laboratories, L.P.. The most commonly reported adverse reactions for BOTULINUM TOXIN TYPE A include OFF LABEL USE, DRUG INEFFECTIVE, HEADACHE, DRUG INTOLERANCE, PRODUCT USE IN UNAPPROVED INDICATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BOTULINUM TOXIN TYPE A.

Top Adverse Reactions

OFF LABEL USE4,497 reports
DRUG INEFFECTIVE3,495 reports
HEADACHE1,481 reports
DRUG INTOLERANCE1,228 reports
PRODUCT USE IN UNAPPROVED INDICATION1,168 reports
NAUSEA1,151 reports
MIGRAINE1,081 reports
PAIN1,060 reports
HYPOAESTHESIA999 reports
DIZZINESS990 reports
FATIGUE958 reports
ASTHENIA911 reports
MUSCULAR WEAKNESS906 reports
PARAESTHESIA837 reports
HYPERTENSION827 reports
GASTROOESOPHAGEAL REFLUX DISEASE806 reports
DYSPNOEA804 reports
MATERNAL EXPOSURE DURING PREGNANCY797 reports
VOMITING791 reports
CONDITION AGGRAVATED778 reports
PRODUCT PREPARATION ERROR762 reports
EPILEPSY755 reports
ABDOMINAL PAIN UPPER754 reports
BLEPHAROSPASM748 reports
DEPRESSION742 reports
CONFUSIONAL STATE730 reports
RASH727 reports
ARTHRALGIA718 reports
INTENTIONAL PRODUCT USE ISSUE718 reports
SWELLING714 reports
HYPERSENSITIVITY705 reports
SYSTEMIC LUPUS ERYTHEMATOSUS698 reports
GENERAL PHYSICAL HEALTH DETERIORATION690 reports
ARTHROPATHY684 reports
RHEUMATOID ARTHRITIS679 reports
PSORIATIC ARTHROPATHY678 reports
TYPE 2 DIABETES MELLITUS673 reports
DIARRHOEA672 reports
PEMPHIGUS671 reports
URTICARIA666 reports
ALOPECIA665 reports
MEMORY IMPAIRMENT663 reports
GLOSSODYNIA662 reports
NECK PAIN662 reports
BURSITIS659 reports
INFUSION RELATED REACTION659 reports
TASTE DISORDER659 reports
SYNOVITIS656 reports
C REACTIVE PROTEIN INCREASED655 reports
DRY MOUTH655 reports
FOLLICULITIS655 reports
PERICARDITIS651 reports
HAND DEFORMITY649 reports
INFLAMMATION639 reports
ABDOMINAL DISCOMFORT637 reports
BREAST CANCER STAGE III627 reports
MUSCLE SPASMS626 reports
BLOOD CHOLESTEROL INCREASED625 reports
DUODENAL ULCER PERFORATION625 reports
HELICOBACTER INFECTION622 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE621 reports
HEPATIC ENZYME INCREASED619 reports
BLISTER610 reports
JOINT SWELLING606 reports
WOUND597 reports
FIBROMYALGIA590 reports
PRODUCT QUALITY ISSUE590 reports
STOMATITIS584 reports
MALAISE576 reports
FACET JOINT SYNDROME574 reports
PERIPHERAL SWELLING571 reports
WEIGHT INCREASED561 reports
CONTRAINDICATED PRODUCT ADMINISTERED560 reports
NASOPHARYNGITIS558 reports
NAIL DISORDER553 reports
OSTEOARTHRITIS553 reports
PNEUMONIA551 reports
WOUND INFECTION551 reports
IRRITABLE BOWEL SYNDROME548 reports
DRUG HYPERSENSITIVITY536 reports
LOWER RESPIRATORY TRACT INFECTION535 reports
WHEEZING534 reports
DYSPEPSIA531 reports
PERIPHERAL VENOUS DISEASE530 reports
IMPAIRED HEALING529 reports
OVERDOSE527 reports
HYPERCHOLESTEROLAEMIA526 reports
PRODUCT USE ISSUE519 reports
TREATMENT FAILURE519 reports
MUSCLE INJURY514 reports
LIP DRY512 reports
INSOMNIA510 reports
GAIT INABILITY507 reports
JOINT RANGE OF MOTION DECREASED507 reports
MOBILITY DECREASED504 reports
OBESITY503 reports
LIVER INJURY497 reports
LUNG DISORDER493 reports
SLEEP DISORDER491 reports
MUSCULOSKELETAL PAIN483 reports

Report Outcomes

Out of 11,691 classified reports for BOTULINUM TOXIN TYPE A:

Serious 53.5%Non-Serious 46.5%

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

Female8,186 (84.3%)
Male1,514 (15.6%)
Unknown7 (0.1%)

Reports by Age

Age 40876 reports
Age 43663 reports
Age 53428 reports
Age 41319 reports
Age 31180 reports
Age 50165 reports
Age 56161 reports
Age 59137 reports
Age 39135 reports
Age 44127 reports
Age 42126 reports
Age 52118 reports
Age 45117 reports
Age 47112 reports
Age 51112 reports
Age 48111 reports
Age 46109 reports
Age 49109 reports
Age 55108 reports
Age 60107 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 BOTULINUM TOXIN TYPE A?

This profile reflects 74,480 FDA FAERS reports that mention BOTULINUM TOXIN TYPE A. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BOTULINUM TOXIN TYPE A?

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

Who manufactures BOTULINUM TOXIN TYPE A?

Labeling and FAERS entries often list Galderma Laboratories, L.P. in connection with BOTULINUM TOXIN TYPE A. 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.