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Aptiom Side Effects

Generic Name: eslicarbazepine

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

In Summary

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

For the Consumer

Applies to eslicarbazepine: oral tablet

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
  • Confusion
  • decreased urine output
  • dizziness
  • fast or irregular heartbeat
  • fever or chills
  • increased in seizure frequency or severity
  • muscle pain or cramps
  • nausea or vomiting
  • severe thirst
  • shortness of breath
  • swelling of the face, ankles, or hands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • 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
  • thoughts or attempts at killing oneself
  • upper right abdominal or stomach pain
  • yellow eyes or skin

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
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common
  • Changes in patterns and rhythms of speech
  • heartburn or indigestion
  • irritability
  • loss of interest or pleasure
  • lower back or side pain
  • 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

Cardiovascular

Common (1% to 10%): Hypertension
Frequency not reported: Palpitations, bradycardia, tachycardia, hypotension, peripheral edema, PR interval prolongation[Ref]

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]

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]

Hematologic

Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Thrombocytopenia, leukopenia
Frequency not reported: Decreased hematocrit, decreased hemoglobin[Ref]

Metabolic

Common (1% to 10%): Hyponatremia, decreased appetite
Uncommon (0.1% to 1%): Electrolyte imbalance, dehydration, hypochloremia[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]

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]

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]

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]

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]

Hepatic

Uncommon (0.1% to 1%): Liver disorder
Frequency not reported: Increased transaminases[Ref]

Other

Common (1% to 10%): Fatigue, asthenia, gait disturbance, peripheral edema
Uncommon (0.1% to 1%): Malaise, chills[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Aptiom (eslicarbazepine)." Sunovion Pharmaceuticals Inc, Marlborough, MA.

Some side effects of Aptiom may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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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