Lacosamide Side Effects

Brand Names: Vimpat

Please note - some side effects for Lacosamide 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 Lacosamide - for the Consumer

Lacosamide

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 Lacosamide:

Blurred vision; dizziness; drowsiness; headache; irritability; mild itching, pain, or redness at the injection site; nausea; tiredness; tremor; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; anxiety; hostility); confusion; dark urine; decreased coordination or loss of balance; double vision or other vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, new or worsening depression); new or worsening seizures; severe or persistent drowsiness, tiredness, or weakness; shortness of breath; suicidal thoughts or attempts; yellowing of the skin or eyes.

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.

Lacosamide Tablets

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 Lacosamide Tablets:

Blurred vision; dizziness; drowsiness; headache; irritability; nausea; tiredness; tremor; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; anxiety; hostility); confusion; dark urine; decreased coordination or loss of balance; double vision or other vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, new or worsening depression); new or worsening seizures; severe or persistent drowsiness, tiredness, or weakness; shortness of breath; suicidal thoughts or attempts; yellowing of the skin or eyes.

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

Nervous system

Nervous system side effects including dizziness (31%), headache (13%), ataxia (8%), somnolence (7%), tremor (7%), nystagmus (5%), balance disorder (4%), memory impairment (2%), paresthesia, cognitive disorder, hypoesthesia, dysarthria, disturbance in attention, and cerebellar syndrome have been reported.

Gastrointestinal

Gastrointestinal side effects including vomiting (9%), diarrhea (4%), nausea (1%), constipation, dyspepsia, dry mouth, and oral hypoesthesia have been reported.

Ocular

Ocular side effects including diplopia (11%) and blurred vision (8%) have been reported.

General

General side effects including fatigue (9%), gait disturbance (2%), asthenia (2%), irritability, pyrexia, and feeling drunk have been reported.

Other

Other side effects including vertigo (4%), contusion (3%), skin laceration (3%), fall, and tinnitus have been reported.

Local

Local side effects following intravenous administration included injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%).

Psychiatric

Psychiatric side effects including depression (2%), confusional state, and altered mood have been reported.

Dermatologic

Dermatologic side effects including pruritus (2%) have been reported.

Cardiovascular

Cardiovascular side effects including palpitations have been reported.

One case of profound bradycardia (26 beats per minute: BP 100/60 mmHg) was observed in a patient during a 15 minute infusion of lacosamide. This patient was also on a beta-blocker. Infusion was discontinued and the patient experienced a rapid recovery.

Musculoskeletal

Musculoskeletal side effects including muscle spasms have been reported.

Hematologic

Hematologic side effects including neutropenia and anemia have been reported.

Hepatic

Abnormalities in liver function tests have been observed in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic drugs. Elevations of ALT to greater than or equal to 3 times the ULN occurred in 0.7% of lacosamide patients and 0% of placebo patients. One case of hepatitis with transaminases greater than 20 times the ULN was observed in one healthy subject 10 days after lacosamide treatment completion, along with nephritis (proteinuria and urine casts).

Hepatic side effects including abnormalities in liver function tests have been reported.

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