BOTOX® treatment is contraindicated in the presence of infection at the
proposed injection site(s) and in individuals with known hypersensitivity to any
ingredient in the formulation.
Patients with neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton
syndrome) should only receive BOTOX® treatment with caution. Patients
with neuromuscular disorders may be at increased risk of clinically significant
systemic effects including difficulty swallowing and breathing difficulties from
typical doses of BOTOX®.
The most frequently reported side effects (3% to 10% of patients) following BOTOX®
injection included injection-site pain and bleeding, non-underarm sweating, infection,
inflammation of the throat, flu syndrome, headache, fever, neck or back pain, itching,
and anxiety.
As with any injection, procedure-related injury could occur. An injection could
result in localized infection, pain, inflammation, tenderness, swelling, erythema,
and/or bleeding/bruising. Caution should be used in patients who have bleeding disorders
or are taking anticoagulants. Needle-related pain and/or anxiety may result in vasovagal
responses, eg, syncope, hypotension, etc. Care should also be taken when injecting
near vulnerable anatomic structures. Reports of pneumothorax related to injection
technique when injecting near the lung or pleura have been received.
Patients should be evaluated for potential causes of secondary hyperhidrosis
(eg, hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the
diagnosis and/or treatment of the underlying disease.
The safety and effectiveness of BOTOX® for hyperhidrosis in other body
areas have not been established. Weakness of hand muscles and blepharoptosis may
occur in patients who receive BOTOX® for palmar hyperhidrosis and facial
hyperhidrosis, respectively.
There are no adequate and well-controlled studies of BOTOX® in pregnant
women. Because animal reproductive studies are not always predictive of human response,
BOTOX® should be administered during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
In general, adverse events occur within the first week following injection of BOTOX®
and while generally transient may have a duration of several months or, in rare
cases, longer.
You should tell your healthcare provider if:
- You are allergic to BOTOX® product or anything in the preparation
- You have a neuromuscular disease such as amyotrophic lateral sclerosis, motor neuropathy,
myasthenia gravis, or Lambert-Eaton syndrome
- You have an infection at the intended site of injection
- You are taking antibiotics or other drugs, such as curare, that may interfere with
neuromuscular transmission
- You are being treated with any medications