Get Informed: Botox
Active Ingredient(s)
Onabotulinumtoxina
Information
- Last Text Update:
- 2009-Nov-19 12:25 AM
- Last Data Update:
- No data
Other Names
- Botox
- Botox Cosmetic
- Onabotulinumtoxina
How Safe Is It?
- Your Risk Rating
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- Average Risk Rating
-
- Pregnancy Category:
- N/A
Black Box Warning
This product has a black box warning indicating that the drug can spread from the injection site and trigger side effects such as difficulty swallowing and breathing.
Facts & Figures
- Date Approved
- 09 Dec 1991
- Est US Patients*
- 97,880
- Generic Available
- No
- OTC Available
- No
User Age Distribution*
< 21
21-39
40-59
60+
Age (Years)
* Estimated number of US people currently taking Botox or its active ingredient based on population adjusted patient numbers registered with iGuard.org.
Other Resources
Botox Safety Report
Learn more about iGuard's risk ratings
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Global Patient Feedback for Botox (Onabotulinumtoxina) ( Post a comment )
Question/Comment:
On April 30,2009 I received an E-Mail from FDA Medwatch informing me that the FDA is requiring these products (licensed botulinum toxin products) to strengthen the warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. The FDA will also require that manufacturers develop and implement a Risk Evaluation. This can be found under: www.FDA Medwatch.gov I will be discussing this with my doctor on my next visit prior to having any further injections for my Benign Essential Blepharospasm and I am questioning as anyone else received any information or experienced any adverse events after receiving these injections?
Shirley /Baltimore, MD
69 year old Female
Posted: 2009-04-30 16:48:45
Answer/Reply:
I get Botox injections @ 3 months for my Cervical Dystonia. The support group I am on (NSTA) had been talking about the bad effects, but previously I felt the good out weighed the bad. I have yet to have my doctor give me any warnings or see the warnings that come with the Botox. IT has been 18 days since my last injections & I have been more "shaky & achy" than prior to the injections. It normally takes 2 - 3 weeks for it to "kick in"
Also I take klonopin (for over 3 years), but have been so exhausted all the time - I have now found out I have Sleep Apnea. I go tonight to be set up for a CPAP, but prior to finding this out, my doctor was hesitant to give me a new script for the Klonopin as he said it can be very dangerous if you have Apnea. I have no idea if I can continue taking it after I get the CPAP, or if the med will have to be changed.
59 year old Female
Posted: 2009-05-16 08:33:00
Question/Comment:
I am a 68 year old female & am taking botox injections for benign essential blepharohspasm. I keep up-to-date on side effects inasmuch as this is a rare condition and no research dollars are being spent on it at my providers location (Johns Hopkins Wilmer Eye Clinic). Type A botulin is the safest injections, there is a type B which has caused deaths if my readings are accurate, and most recently there was an article which stated that it is being absorbed in the small muscles which go to the brain..no further research data. I suggest all users contact: Benign Essential Blepharospasm Research Foundation Inc., P.O. Box 12468, Beaumont, Texas 77726: Phone 409-832-0788 E-Mail bebrf@sbcglobal.net Internet:www.blepharospasm.org/ I still do not have a comfort zone with these injections but it is the only way I can see every 3 mons. The mfgr is making a bundle inasmuch as it is used for cosmetic purposes and limited information is being given out/being compiled as to interaction or side effects.
69 year old Female
Posted: 2008-12-27 06:27:31
Question/Comment:
I need Botox for Dystonia, I have only been able to get it once, due to Insurance problems, I need it @ 3 months. The one time I did have it, after a few days, it made a big differnece in the muscle spasms, aches, pains & head jerking & tremors.
56 year old female
59 year old Female
Posted: 2008-06-02 22:23:57
Answer/Reply:
I have dystonia and blepharspasms and I receive botox every 3 months around both eyes and in eye lids...If it wasn't for the botox I would not be able to open my eyes! ...I now also get botox in my chin area as my mouth muscles would go into a grimace and botox has also stopped my mouth from drooping..I have been getting botox for more than 12 years....at times I have trouble swallowing and just wait for the food in my throat to go down before I can even drink liquids as I almost choked to death on water that wouldn't go down as my throat felt like it closed..It doesn't happen too often...just once in a while and now I have learned to sit still till my throat muscles allow what is in it to pass down. My insurance covers it as it is necessary for me to be able to see!
56 year old Female
Posted: 2008-11-20 17:10:58
Question/Comment:
Am taking for Dystonia - Am being treated with Botox every 6 months - still have spasms.
72 year old Female
Posted: 2008-02-18 10:06:24
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Comments may be either questions or answers to previously posted questions. Any iGuard.org user may post questions and reply.
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Patient Comments about
Botox