Drug Safety Information for BOTOX COSMETIC (Botulinum toxin type a)

Adverse Drug Reactions for BOTOX COSMETIC* (Botulinum toxin type a)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with BOTOX COSMETIC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective8142
2Therapeutic response decreased2283
3Wrong technique in drug usage process1644
4Off label use1435
5Eyelid ptosis1415
6Headache1191
7Injection site pain1098
8Dysphagia869
9Muscular weakness802
10Dyspnoea610
11Asthenia561
12Fatigue560
13Nausea551
14Dizziness524
15Vision blurred520
16Facial paresis510
17Swelling face420
18Influenza like illness399
19Pain391
20Neck pain385

* This side effect also appears in "Top 10 Side Effects of BOTOX COSMETIC " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking BOTOX COSMETIC
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Skin wrinkling28090
2Migraine3526
3Product used for unknown indication3159
4Torticollis2271
5Muscle spasticity2178
6Skin cosmetic procedure1083
7Blepharospasm994
8Hyperhidrosis718
9Muscle spasms532
10Off label use525

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for BOTOX COSMETIC

Total Reports Filed with FDA: 54116


Number of FDA Adverse Event Reports by Patient Age for BOTOX COSMETIC

Total Reports Filed with FDA: 54116*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Botulinum toxin type a (Xeomin, Botox cosmetic, Dysport, Botox)

Charts are based on 54116 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and BOTOX COSMETIC Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.