The FDA has recently made available all data for adverse reactions or what we call “side effects” for FDA approved drugs. I was able to have an associate do some legwork and collect all the data for Botox aka “botulinum toxin” and kind of make a “best of” list. Much of the data was redundant and irrelevant.

The first table shows the outcome of the reaction from Botox based on the FDA’s 6 main types of reports.

Outcome botulinum
Fatal 1.8%
Not recovered/not resolved 16.4%
Recovered/resolved 25.5%
Recovered/resolved with sequelae 3.6%
Recovering/resolving 10.0%
Unknown 42.7%

Top 20 Adverse Effects of Botox

Next you will find the counts of reactions from Botox. The labels are taken from the MedDRA dictionary for the name of each reaction.

DYSPHAGIA 165
DRUG INEFFECTIVE 158
MUSCULAR WEAKNESS 153
HEADACHE 112
EYELID PTOSIS 102
FATIGUE 90
ASTHENIA 89
DYSPNOEA 89
DIZZINESS 69
NECK PAIN 60
VISION BLURRED 53
NAUSEA 52
WRONG TECHNIQUE IN DRUG USAGE PROCESS 49
DYSPHONIA 47
THERAPEUTIC RESPONSE DECREASED 47
DIPLOPIA 44
INFLUENZA LIKE ILLNESS 44
BOTULISM 39
INJECTION SITE PAIN 39
SWELLING FACE 38

Botox Adverse Effects by Age

This is the graph of the age that Botox patients first experience an event or side effect that is included in these reports based on their age.

botox reports adverse effects by age