Note: This document contains side effect information about eslicarbazepine. Some dosage forms listed on this page may not apply to the brand name Aptiom.

Summary

Common side effects of Aptiom include: ataxia, balance impairment, blurred vision, diplopia, dizziness, drowsiness, headache, nausea, tremor, vertigo, abnormal gait, asthenia, fatigue, hypersomnia, nystagmus disorder, sedated state, visual disturbance, and malaise. Other side effects include: psychomotor impairment, hyponatremia, amnesia, aphasia, cognitive dysfunction, confusion, disorientation, memory impairment, mental disorders, and speech disturbance. Continue reading for a comprehensive list of adverse effects.

Applies to eslicarbazepine: oral tablet.

Serious side effects of Aptiom

Along with its needed effects, eslicarbazepine (the active ingredient contained in Aptiom) 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 eslicarbazepine:

Less common

• Chills
• confusion
• decreased urine output
• dizziness
• fast or irregular heartbeat
• fever
• increased in seizure frequency or severity
• muscle pain or cramps
• nausea
• severe thirst
• swelling of the face, ankles, or hands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unusual tiredness or weakness
• vomiting

Less common

• Blistering, peeling, or loosening of the skin
• bloating of the abdomen or stomach
• changes in behavior
• discouragement
• difficulty breathing
• difficulty swallowing
• feeling sad or empty
• hives, rash, or itching skin
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• thoughts or attempts at killing oneself
• upper right abdominal or stomach pain
• yellow eyes or skin

Incidence not known

• Agitation
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain
• cough
• hoarseness
• decreased awareness or responsiveness
• fainting spells
• general feeling of tiredness or weakness
• headache
• high fever
• hostility
• irregular heartbeat
• irritability
• loss of consciousness
• lower back or side pain
• muscle twitching
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• severe sleepiness
• sore throat
• unusual bleeding or bruising
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects of Aptiom

Some side effects of eslicarbazepine 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
• sensation of spinning or constant movement
• sleepiness

Less common

• Changes in patterns and rhythms of speech
• heartburn
• indigestion
• loss of interest or pleasure
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• trouble concentrating
• unusual weight gain or loss

For Healthcare Professionals

Applies to eslicarbazepine: oral tablet.

General

The more commonly reported adverse events have included dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Alopecia, dry skin, hyperhidrosis, erythema, skin disorder, pruritus

Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), nail disorder^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia

Rare (less than 0.1%): Thrombocytopenia, leukopenia

Frequency not reported: Decreased hematocrit, decreased hemoglobin

Postmarketing reports: Agranulocytosis, megoblastic anemia, pancytopenia^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 28%), somnolence (up to 18%), headache (up to 15%)

Common (1% to 10%): Vertigo, ataxia, balance disorder, tremor, dysarthria, memory impairment

Uncommon (0.1% to 1%): Coordination abnormal, memory impairment, amnesia, hypersomnia, sedation, aphasia, dysesthesia, dystonia, lethargy, parosmia, cerebellar syndrome, convulsion, peripheral neuropathy, nystagmus, speech disorder, dysarthria, burning sensation, paresthesia, migraine^[Ref]

Metabolic

Common (1% to 10%): Hyponatremia, decreased appetite

Uncommon (0.1% to 1%): Electrolyte imbalance, dehydration, hypochloremia^[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia

Uncommon (0.1% to 1%): Apathy, depression, nervousness, agitation, irritability, attention deficit/hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, psychotic disorder^[Ref]

Ocular

Very common (10% or more): Diplopia (up to 11%)

Common (1% to 10%): Blurred vision, visual impairment

Frequency not reported: Oscillopsia, binocular eye movement disorder, ocular hyperemia, saccadic eye movement, eye pain^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Palpitations, bradycardia, tachycardia, hypotension, peripheral edema, PR interval prolongation^[Ref]

Hepatic

Uncommon (0.1% to 1%): Liver disorder

Frequency not reported: Increased transaminases^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 16%), vomiting (up to 10%)

Common (1% to 10%): Diarrhea, constipation, abdominal pain

Uncommon (0.1% to 1%): Gastritis, dyspepsia, dry mouth, abdominal discomfort, abdominal distension, gingivitis, melena, toothache

Frequency not reported: Duodenitis, epigastric discomfort, irritable bowel syndrome, odynophagia, stomatitis, increased appetite, decreased appetite, and ageusia^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection^[Ref]

Musculoskeletal

Common (1% to 10%): Falls, asthenia

Uncommon (0.1% to 1%): Myalgia, bone metabolism disorder, muscular weakness, pain in extremity, back pain, neck pain^[Ref]

Respiratory

Common (1% to 10%): Cough

Uncommon (0.1% to 1%): Epistaxis, chest pain

Frequency not reported: Dysphonia^[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism^[Ref]

Other

Common (1% to 10%): Fatigue, asthenia, gait disturbance, peripheral edema

Uncommon (0.1% to 1%): Malaise, chills^[Ref]