Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Serious Dermatologic Reactions [see Warnings and Precautions ( 5.2 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.4 )] • Hyponatremia [see Warnings and Precautions ( 5.5 )] • Neurological Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Drug Induced Liver Injury [see Warnings and Precautions ( 5.8 )] • Abnormal Thyroid Function Tests [see Warnings and Precautions ( 5.9 )] • Pancytopenia, Agranulocytosis, and Leukopenia [see Warnings and Precautions ( 5.10 )] • Most common adverse reactions in adult patients receiving eslicarbazepine acetate (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.
( 6.1 ) • Adverse reactions in pediatric patients are similar to those seen in adult patients.
To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy’s Laboratories, Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adult Patients In monotherapy trials in patients with partial-onset seizures [Study 1 and Study 2, see Clinical Studies ( 14.1 ) ], 365 patients received eslicarbazepine acetate, of whom 225 were treated for longer than 12 months and 134 for longer than 24 months.
Of the patients in those trials, 95% were between 18 and 65 years old;
48% were male, and 84% were Caucasian.
Across controlled and uncontrolled trials in patients receiving adjunctive therapy for partial-onset seizures, 1,195 patients received eslicarbazepine acetate, of whom 586 were treated for longer than 6 months and 462 for longer than 12 months.
In the placebo controlled adjunctive therapy trials in patients with partial-onset seizures (Study 3, Study 4 and Study 5), 1,021 patients received eslicarbazepine acetate.
5 WARNINGS AND PRECAUTIONS • Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior.
( 5.1 ) • Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Anaphylactic Reactions and Angioedema: Monitor and discontinue if another cause cannot be established.
( 5.2 , 5.3 , 5.4 ) • Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms.
( 5.5 ) • Neurological Adverse Reactions: Monitor for dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes.
Use caution when driving or operating machinery.
Like all medications, Eslicarbazepine Acetate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: