Botulinum toxin type A Side Effects

Please note - some side effects for Botulinum toxin type A may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Botulinum toxin type A - for the Consumer

Botulinum Toxin Type A

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Botulinum Toxin Type A:

Anxiety; back pain; dizziness; drowsiness; dry mouth; dry or irritated eyes; facial pain; flu-like symptoms; headache; inability to focus eyes; increased cough; indigestion; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; sensitivity to light; stiff or weak muscles at or near the injection site; sweating.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bleeding at the injection site; chest pain; difficulty swallowing or breathing; double or blurred vision or other vision changes; drooping of the upper eyelid; eyelid swelling; fainting; fever, chills, or persistent sore throat; irregular heartbeat; loss of bladder control; loss of strength; paralysis; seizures; severe or persistent muscle weakness or dizziness; shortness of breath; speech changes or problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

In general, side effects occur in the first week following administration of botulinum toxin type A and are generally transient; however, there are some reports of several months duration.

Other

Other side effects have rarely included spontaneous reports of death with and without an association to a significant debility or anaphylaxis.

Other side effects reported during treatment for cervical dystonia have included dysphagia (19%) and headache (11%). Flu syndrome, oral dryness, fever, and speech disorder have been reported in 2% to 10% of patients. Dysphonia has been reported rarely.

Other side effects reported during treatment for primary axillary hyperhidrosis have included non-axillary sweating, infection, pharyngitis, flu syndrome, headache, and fever in 3% to 10% of patients.

Other side effects reported during treatment for glabellar lines have included headache (13.3%), pain in the face (2.2%), flu syndrome (2%), back pain (1%), tooth disorder (1%), and accidental injury (0.7%).

Dysphagia is a commonly reported adverse event following treatment of cervical dystonia with all botulinum toxins. Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory difficulties occur.

Respiratory

Respiratory side effects reported during treatment for cervical dystonia have included respiratory infection (12%). Increased cough and rhinitis have been reported in 2% to 10% of patients. Dyspnea has been reported rarely.

Respiratory side effects reported during treatment for glabellar lines have included respiratory infection (3.5%), bronchitis (1.5%), sinusitis (1.5%), pharyngitis (1.2%), sinus infection (0.7%), laryngitis (0.7%), rhinitis (0.7%), and dyspnea (0.7%).

Ocular

Ocular side effects reported during treatment for cervical dystonia have rarely included diplopia and ptosis.

Ocular side effects reported during treatment for blepharospasm have included ptosis (20.8%), superficial punctate keratitis (6.3%), eye dryness (up to 6.3%), diplopia (2.1%), blurred vision (0.2%), irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, and entropion have been reported. A single case of acute angle closure glaucoma has also been reported.

Ocular side effects reported during treatment for strabismus have included ptosis, vertical deviation, spatial disorientation, double vision, past-pointing, vitreous hemorrhage (1 case), retrobulbar hemorrhage, pupillary change, anterior segment ischemia (1 case).

Ocular side effects reported during treatment for glabellar lines have included blepharoptosis (3.2%).

A study for the treatment of blepharospasm with an average dose of 33 units per eye injected at 3 to 5 sites reported ptosis in 20.8% of patients with only one case being classified as severe.

A case of acute angle closure glaucoma was reported in a patient within 1 day of treatment for blepharospasm. The patient recovered 4 months later following laser iridotomy and trabeculectomy.

Nervous system

Nervous system side effects reported during treatment for cervical dystonia have included dizziness and drowsiness in 2% to 10% of patients. Numbness has been reported rarely.

Nervous system side effects reported during treatment for primary axillary hyperhidrosis have included anxiety (3% to 10%).

Nervous system side effects reported during treatment for hyperhidrosis have included VII nerve disorder (2 cases), focal facial paralysis, syncope, and exacerbation of myasthenia gravis.

Nervous system side effects reported during treatment for glabellar lines have included dizziness (1.2%), paresthesia (1%), anxiety (0.7%), and twitch (0.7%).

The manufacturer reports two cases of VII nerve disorder. The first case, aphakic eye, resulted in perforation and required corneal grafting. The second case, reduced blinking, occurred following injection of botulinum toxin type A into the orbicularis muscle and resulted in serious corneal exposure, persistent epithelial defect, and corneal ulceration.

Musculoskeletal

Musculoskeletal side effects reported during treatment for cervical dystonia have included neck pain (11%). Back pain, asthenia, and hypertonia have been reported in 2% to 10% of patients. Stiffness has been reported rarely.

Musculoskeletal side effects reported during treatment for primary axillary hyperhidrosis have included neck or back pain (3% to 10%)

Musculoskeletal side effects reported during treatment for glabellar lines have included muscle weakness (2%).

Cardiovascular

A female patient developed brachial plexopathy 2 days following administration of botulinum toxin type A 120 units for the treatment of cervical dystonia.

Cardiovascular side effects have rarely included arrhythmia and myocardial infarction; however, a causal relationship with botulinum toxin type A has not been determined.

Cardiovascular side effects reported during treatment for cervical dystonia have included a single case of brachial plexopathy.

Cardiovascular side effects reported during treatment for glabellar lines have included hypertension (1%).

Hypersensitivity

The manufacturer reports a single fatal case of anaphylaxis involving botulinum toxin A diluted with lidocaine; however, a causal agent was not established.

Hypersensitivity side effects have rarely included anaphylaxis, urticaria, soft tissue edema, and dyspnea.

Local

Local side effects reported during treatment for cervical dystonia have included soreness at the injection site (2% to 10%).

Local side effects reported during treatment for primary axillary hyperhidrosis have included injection site pain and hemorrhage in 3% to 10% of patients.

Local side effects reported during treatment for blepharospasm have included swelling of the eyelid skin.

Local side effects reported during treatment for glabellar lines have included pain (1.7%) and edema (1.5%) at the injection site.

Swelling of the eyelid skin may last several days following treatment for blepharospasm.

Dermatologic

Dermatological side effects have included rash, erythema multiforme, urticaria, psoriasiform eruption, and pruritus. However, a causal relationship with botulinum toxin type A has not been established.

Dermatological side effects reported during treatment for primary axillary hyperhidrosis have included pruritus (3% to 10%).

Dermatological side effects reported during treatment for blepharospasm have included diffuse skin rash.

Dermatologic side effects reported during treatment for glabellar lines have included erythema (1.7%), ecchymosis (1.7%), skin tightness (1%), and irritation (0.7%).

Gastrointestinal

Gastrointestinal side effects reported during treatment for cervical dystonia have included nausea (2% to 10%).

Gastrointestinal side effects reported during treatment for glabellar lines have included nausea (3%) and dyspepsia (1%).

Genitourinary

Genitourinary side effects during treatment for glabellar lines have included urinary tract infection (1%).

Hepatic

Hepatic side effects reported during treatment for glabellar lines have included abnormal liver function tests (0.7%).

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