Lacosamide Side Effects

It is possible that some side effects of lacosamide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to lacosamide: oral solution, oral tablet

Other dosage forms:

Along with its needed effects, lacosamide 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 immediately if any of the following side effects occur while taking lacosamide:

More common
  • Dizziness
  • false or unusual sense of well-being
  • shakiness and unsteady walk
  • sleepiness or unusual drowsiness
  • trembling or shaking of the hands or feet
  • unsteadiness, trembling, or other problems with muscle control or coordination
Less common
  • Being forgetful
  • discouragement
  • feeling sad or empty
  • irritability
  • itching skin
  • lack of appetite
  • loss of balance control
  • loss of interest or pleasure
  • mood or mental changes
  • tearing of the skin
  • tiredness
  • trouble concentrating
  • trouble with sleeping
  • trouble with walking
Incidence not known
  • Abnormal or decreased touch sensation
  • black, tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in patterns and rhythms of speech
  • chills
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling drunk
  • fever
  • hearing loss
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • shortness of breath
  • slurred speech
  • sore throat
  • trouble performing routine tasks
  • trouble with balance
  • trouble with speaking
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some side effects of lacosamide 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
  • Blurred vision
  • double vision
  • headache
  • nausea
  • seeing double
  • vomiting
Less common
  • Diarrhea
  • feeling of constant movement of self or surroundings
  • lack or loss of strength
  • sensation of spinning
  • uncontrolled eye movements
Incidence not known
  • Acid or sour stomach
  • belching
  • difficulty having a bowel movement (stool)
  • dry mouth
  • heartburn
  • indigestion
  • muscle spasms
  • stomach discomfort, upset, or pain

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. Agranulocytosis has been reported postmarketing.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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