IMPORTANT SAFETY INFORMATION (continued)
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.
BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks
of receiving BOTOX.
If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX if you
are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction
to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB),
Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA);
have a skin infection at the planned injection site.
Do not receive BOTOX for the treatment of urinary incontinence
have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able
to initiate catheterization posttreatment, if required, should be considered for treatment.
Patients treated for overactive bladder:
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment
with BOTOX compared to 2 of the 542 treated with placebo.
The median duration of postinjection catheterization for these patients treated with BOTOX
100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of
11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2).
Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.
Adult patients treated for overactive bladder due to a neurologic disease:
In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC)
prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units,
as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization
for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days),
as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection
than those with spinal cord injury.
The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported,
including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint.
Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued.
Tell your doctor about all your muscle or nerve conditions,
such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome,
as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing
from typical doses of BOTOX.
Tell your doctor if you have any breathing-related problems.
Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity
or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease
in patients with reduced lung function is increased in patients receiving BOTOX.
Cornea problems have been reported.
Cornea (surface of the eye) problems have been reported in some people receiving BOTOX
for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids
to blink less, which could lead to the surface of the eye being exposed to air more than is usual.
Tell your doctor if you experience any problems with your eyes while receiving BOTOX.
Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported.
Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus.
Tell your doctor if you notice any new visual problems while receiving BOTOX.
Bronchitis and upper respiratory tract infections (common colds) have been reported.
Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity.
Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity.
In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported
In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported
more frequently than placebo.
Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease.
Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor
overactivity associated with a neurologic condition and may require prompt medical therapy.
In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX
200 Units compared with placebo (1.5% versus 0.4%, respectively).
Tell your doctor about all your medical conditions, including if you
have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles,
trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI
and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination,
frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence;
are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby);
are breastfeeding or plan to (it is not known if BOTOX passes into breast milk).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using BOTOX with certain other medicines may cause serious side effects.
Do not start any new medicines until you have told your doctor that you have received
BOTOX in the past.
Tell your doctor if you received any other botulinum toxin product in the last 4 months;
have received injections of botulinum toxin such as Myobloc®, Dysport®,
or Xeomin® in the past (tell your doctor exactly which product you received);
have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine;
take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX include
dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision,
blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows;
and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include
UTI and painful urination. In children being treated for urinary incontinence, other side effects include
UTI and bacteria in the urine. In patients being treated for urinary incontinence, another side effect includes the inability
to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after
receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your
bladder is able to start emptying again.
For more information, refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Please see BOTOX®
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