Lacosamide Side Effects

Some side effects of lacosamide 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 lacosamide: oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking lacosamide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Stop using lacosamide and call your doctor at once if you have:

• double vision, hallucinations;

• a light-headed feeling, like you might pass out;

• fast or pounding heartbeats, fluttering in your chest;

• shortness of breath;

• fever, skin rash, swollen glands, flu symptoms;

• bruising, severe tingling, numbness, pain, muscle weakness;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• lower back pain, cloudy or bloody urine, swelling, rapid weight gain, urinating less than usual.

Common side effects may include:

• mild dizziness;

• loss of balance or coordination;

• headache; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to lacosamide: intravenous solution, oral solution, oral tablet

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, hallucination, and altered mood have been reported.

Dermatologic

Dermatologic side effects including pruritus (2%) and rash 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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