Nabota Adverse Reactions

General: In general, adverse events occur within the 1st week following injection of botulinum toxin products and are transient. As is expected for any IM injection procedure, localized pain, tenderness and/or bruising may be associated with the injection. Local weakness represents the expected pharmacological action of botulinum toxin.
The following list includes adverse drug reactions or other medically relevant adverse events that have been reported since the drug has been marketed, regardless of indication: Denervation/muscle atrophy; respiratory depression and/or respiratory failure (noncosmetic indications); dyspnea; aspiration pneumonia (noncosmetic indications); dysarthria; dry mouth; strabismus, peripheral neuropathy, abdominal pain; diarrhea; nausea; vomiting; pyrexia; anorexia; blurred vision; visual disturbance; hypoacusis; tinnitus; vertigo; facial palsy; facial paresis; brachial plexopathy; radiculopathy; syncope; hypoesthesia; malaise; myalgia; myasthenia gravis; paresthesia; rash; erythema multiforme; pruritus; dermatitis psoriasiform; hyperhidrosis; and alopecia, including madarosis.
There have been rare spontaneous reports of death, sometimes associated with dysphagia, pneumonia and/or other significant debility after treatment with botulinum toxin type A. There have also been rare reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease.
Blepharospasm: In reported study of other botulinum toxin product, adverse events observed mostly were ptosis, superficial punctate keratitis and eye dryness. And in the results from other clinical studies and using experience with other botulinum toxin products, irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, diplopia and entropion, diffuse skin rash and local swelling of the eyelid skin lasting for several days following eyelid injection, angle closure glaucoma, visual disturbance and facial weakness have also been reported.
During administration of other botulinum toxin product, in 2 cases of VII^th nerve disorder (1 case of an aphakic eye), reduced blinking from botulinum toxin injection of the orbicularis muscle led to serious corneal exposure, persistent epithelial defect and corneal ulceration. Perforation occurred in the aphakic eye and required corneal grafting. Vigorous treatment of any corneal epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses or closure of the eye by patching or other means.
Hemifacial Spasm: Adverse events reported after injection of other botulinum toxin products have included blurring of vision, facial droop, dizziness and tiredness, in addition to those listed previously under blepharospasm treatment.
Strabismus: During administration of other botulinum toxin product for treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred owing to penetration of the needle into areas surrounding eyes. It is recommended that appropriate instruments to decompress the orbit be accessible. Ocular (globe) penetrations by needles have also occurred. An ophthalmoscope to diagnose this condition should be available. Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past-pointing. Covering the affected eye may alleviate these symptoms.
Cervical Dystonia: The following adverse events were reported in clinical study of other botulinum product. The frequency of adverse reactions reported defined as follows: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000).
Very common: pain, focal weakness, dysphagia.
Common: soreness, malaise, general weakness, upper respiratory infection, nausea, headache, drowsiness, stiffness, dry mouth, dizziness, rhinitis and hypertonia.
Dysphagia and symptomatic general weakness may be attributable to an extension of the pharmacology of botulinum toxin product resulting from the spread of the toxin outside the injected muscles. Dysphagia is usually reported as mild to moderate severity in most patients. However, in an occasional patient, it may be associated with more severe problems (see Precautions). Other treatment-related adverse events include numbness, diplopia, ptosis, dyspnea, fever and flu syndrome.
Cerebral Palsy: As is expected for any IM injection procedure, localized pain may be associated with the injection in these patients. The adverse reactions most frequently reported as related to treatment include falling, leg pain, leg (local) weakness.
Falling may be attributed to a change in the ankle position and gait and/or local weakness. Local weakness represents the expected pharmacological action of botulinum toxin.
Glabellar Lines: Safety of NABOTA was evaluated in multicenter, comparative, double-blinded, randomized studies which included 268 patients aged between 20 to 65, with moderate to severe glabella lines (test group 135, control group 133). Adverse reactions were observed in 20.00% of test group, and in 18.05% of control group.
Most of the adverse reactions were mild, and none was severe. Adverse reactions reported more than 1% in the test group of this drug, listed in the order of frequency are; ptosis (2.22%), raised eyebrows (1.48%), and vertigo (1.48%).
Crow's Feet: In information reported in safety study with other botulinum toxin, most adverse events reported were of mild to moderate severity and all were transient. The most frequently reported treatment-related adverse events were injection site hemorrhage ie, bruising at the injection site and headache.
Other studies have reported the incidence of injection site bruising to be between 4-25% of botulinum toxin product-treated patients, included temporary droop of the lateral portion of the lower eyelid, which is consistent with the pharmacologic action of botulinum toxin product and may be injection technique-related.
Forehead Lines: Adverse events including headache, bruising, eyebrow ptosis, eyelid swelling, aching/itching forehead and nausea were reported in the clinical study of other botulinum toxin product.
Focal Spasticity in Adults: In multicenter, double-blinded, randomized active-controlled trial with 197 post-stroke patients aged over 18 years, more than 6 weeks since stroke onset, safety in upper limb spasticity was evaluated. Adverse reactions occurred in 19.59% of the test group treated NABOTA and 19.39% of the control group.
Most of the adverse reactions were mild, and none was severe. Adverse reactions reported in this clinical study were 3 cases in the test group of this drug and 4 cases in the control group.
The frequency of adverse reactions reported in the clinical trials is defined as follows: Very Common (≥ 1/10); Common (≥1/100 to <1/10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000).
Adverse reactions reported commonly in treatment of this drug were listed as follows: See Table 5.

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Hyperhidrosis of the Axilla: In studies with other botulinum toxin product, adverse events reported as treatment related in >1% of botulinum toxin product-treated patients were perceived increase in non-axillary sweating, injection site pain, pain and vasodilation (hot flushes).
Chronic Migraine: In studies with other botulinum toxin product, adverse events reported in common were headache, migraine, facial paresis, eyelid ptosis, injection site pain, pruritus, rash, neck pain, musculoskeletal stiffness, muscular weakness, myalgia, musculoskeletal pain, muscle spasms and muscle tightness.