Botox Cosmetic Side Effects
Generic Name: onabotulinumtoxinA
Note: This document contains side effect information about onabotulinumtoxinA. Some of the dosage forms listed on this page may not apply to the brand name Botox Cosmetic.
Some side effects of Botox Cosmetic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to onabotulinumtoxinA: powder for solution
Along with its needed effects, onabotulinumtoxinA (the active ingredient contained in Botox Cosmetic) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking onabotulinumtoxinA:More common
- Difficulty with swallowing
- Difficulty with breathing or speaking
- muscle weakness
- Dryness of the eyes
- inability to close the eyelids completely
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- Decreased blinking
- irritation of the cornea (colored portion) of the eyes
- turning outward or inward of the edge of the eyelids
- Swelling of the eyelids
Some side effects of onabotulinumtoxinA may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common—for blepharospasm
- Blue or purplish bruise on the eyelids
- drooping of the upper eyelids
- irritation or watering of the eyes
- sensitivity of the eyes to light
- Body aches or pain
- cough, fever, sneezing, or sore throat
- ear congestion
- loss of voice
- nasal congestion
- neck pain
- runny nose
- unusual tiredness or weakness
- Neck pain
- Body aches or pain
- dryness or soreness of the throat
- general feeling of discomfort or illness
- heavy bleeding from the place where shot was given
- itching skin
- joint pain
- loss of appetite
- painful or difficult urination
- runny nose
- tender, swollen glands in the neck
- trouble sleeping
- trouble swallowing
- voice changes
- Drooping of the upper eyelid
- eye pointing upward or downward instead of straight ahead
- Muscle weakness
- pain in the arms
- Skin rash
- swelling of the eyelid skin
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blurred vision
- body aches or pain
- cough producing mucus
- difficulty breathing
- drooping of the upper eyelid
- muscle aches and pains
- pounding in the ears
- slow or fast heartbeat
- tightness in the chest
- Difficulty finding the location of objects
- double vision
- Cough producing mucus
- difficulty breathing
- shortness of breath
- tightness in the chest
For Healthcare Professionals
Applies to onabotulinumtoxinA: injectable powder for injection
Gastrointestinal side effects have included nausea (2 to 3%), oral dryness (2 to 10%), and dysphagia (2 to 10%).
Nervous system side effects have included fatigue (2 to 3%), dizziness (2 to 10%), fever (2 to 10%), drowsiness (2 to 10%), and numbness (2 to 10%). New or recurrent seizures have been reported, usually in patients who are predisposed to experiencing these events. The exact relationship of these events to the injection of onabotulinumtoxinA (the active ingredient contained in Botox Cosmetic) has not been established.
Respiratory side effects have included bronchitis (2 to 3%), increased cough (2 to 10%), rhinitis (2 to 10%), and dyspnea (2 to 10%).
Musculoskeletal side effects have included pain in extremity (6%), muscle weakness (4%), asthenia (2 to 10%), back pain (2 to 10%), hypertonia (2 to 10%), and stiffness (2 to 10%).
Cardiovascular side effects have included arrhythmia and myocardial infarction, some with fatal outcomes. Some patients had risk factors including cardiovascular disease. The exact relationship of these events to the injection of onabotulinumtoxinA (the active ingredient contained in Botox Cosmetic) has not been established.
Local side effects have included soreness at injection site (2 to 10%).
Immunologic side effects have included flu syndrome (2 to 10%).
In two cases of VII nerve disorder, reduced blinking from onabotulinumtoxinA (the active ingredient contained in Botox Cosmetic) injection of the orbicularis muscle led to serious corneal exposure, persistent epithelial defect, corneal ulceration and a case of corneal perforation. Focal facial paralysis, syncope, and exacerbation of myasthenia gravis have also been reported after treatment of blepharospasm.
Extraocular muscles adjacent to the injection site can be affected, causing vertical deviation, especially with higher doses of onabotulinumtoxinA. The incidence rates of these adverse effects in 2058 adults who received a total of 3650 injections for horizontal strabismus was 17%.
The incidence of ptosis has been reported to be dependent on the location of the injected muscles, 1% after inferior rectus injections, 16% after horizontal rectus injections and 38% after superior rectus injections.
In a series of 5587 injections, retrobulbar hemorrhage occurred in 0.3% of cases.
Ocular side effects have included diplopia (2 to 10%) and ptosis (2 to 10%). Other events reported in prior clinical studies in decreasing order of incidence include: irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, diplopia, entropion, diffuse skin rash, and local swelling of the eyelid skin lasting for several days following eyelid injection.
Other side effects have included speech disorder (2 to 10%). Other side effects reported postmarketing have included abdominal pain, anorexia, brachial plexopathy, diarrhea, facial palsy, facial paresis, hyperhidrosis, hypoacusis, hypoesthesia, localized numbness, malaise, myalgia, paresthesia, pyrexia, radiculopathy, skin rash (including erythema multiforme, and psoriasiform eruption), tinnitus, vertigo, visual disturbances, and vomiting.
Side effects occurring most commonly in patients with cervical dystonia have included dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%). One female patient treated for cervical dystonia developed brachial plexopathy 2 days after injection of 120 Units of onabotulinumtoxinA.
Other side effects occurring after treatment for axillary hyperhidrosis at a frequency of 3 to 10% have included injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.
More about Botox Cosmetic (onabotulinumtoxinA)
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