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.