Lamotrigine Er Side Effects

The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: • Serious Skin Rashes [see Warnings and Precautions (5.1)] • Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.2)] • Multiorgan Hypersensitivity Reactions and Organ Failure [see Warnings and Precautions (5.3)] • Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.4)] • Blood Dyscrasias [see Warnings and Precautions (5.5)] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.6)] • Aseptic Meningitis [see Warnings and Precautions (5.7)] • Withdrawal Seizures [see Warnings and Precautions (5.10)] • Status Epilepticus [see Warnings and Precautions (5.11)] • Sudden Unexplained Death in Epilepsy [see Warnings and Precautions (5.12)] 6.1 Clinical Trial Experience with Lamotrigine Extended-Release Tablets for Treatment of Primary Generalized Tonic-Clonic and Partial-Onset Seizures Most Common Adverse Reactions in Clinical Trials Adjunctive Therapy in Patients with Epilepsy: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In these 2 trials, adverse reactions led to withdrawal of 4 (2%) patients in the group receiving placebo and 10 (5%) patients in the group receiving Lamotrigine Extended-Release Tablets.

Dizziness was the most common reason for withdrawal in the group receiving Lamotrigine Extended-Release Tablets (5 patients [3%]).

The next most common adverse reactions leading to withdrawal in 2 patients each (1%) were rash, headache, nausea, and nystagmus.

Table 4 displays the incidence of adverse reactions in these two 19-week, double-blind, placebo-controlled trials of patients with PGTC and partial onset seizures.

Adverse Reactions in Pooled, Placebo-Controlled, Adjunctive Trials in Patients with Epilepsy a Body System/ Adverse Reaction Percent of Patients Receiving Adjunctive Lamotrigine Extended-Release Tablets (n = 190) Percent of Patients Receiving Adjunctive Placebo (n = 195) Ear and labyrinth disorders Vertigo 3 <1 Eye disorders Diplopia Vision blurred 5 3 <1 2 Gastrointestinal disorders Nausea Vomiting Diarrhea Constipation Dry mouth 7 6 5 2 2 4 3 3 <1 1 General disorders and administration site conditions Asthenia and fatigue 6 4 Infections and infestations Sinusitis 2 1 Metabolic and nutritional disorders Anorexia 3 2 Musculoskeletal and connective tissue disorder Myalgia 2 0 Nervous system Dizziness Tremor and intention tremor Somnolence Cerebellar coordination and balance disorder Nystagmus 14 6 5 3 2 6 1 3 0 <1 Psychiatric disorders Depression Anxiety 3 3 <1 0 Respiratory, thoracic, and mediastinal disorders Pharyngolaryngeal pain 3 2 Vascular disorder Hot flush 2 0 a Adverse reactions that occurred in at least 2% of patients treated with Lamotrigine Extended-Release Tablets and at a greater incidence than placebo.

Note: In these trials the incidence of nonserious rash was 2% for Lamotrigine Extended-Release Tablets and 3% for placebo.

In clinical trials evaluating immediate-release lamotrigine, the rate of serious rash was 0.3% in adults on adjunctive therapy for epilepsy [see Boxed Warning].

Adverse reactions were also analyzed to assess the incidence of the onset of an event in the titration period, and in the maintenance period, and if adverse reactions occurring in the titration phase persisted in the maintenance phase.

The incidence for many adverse reactions caused by treatment with Lamotrigine Extended-Release Tablets was increased relative to placebo (i.e., treatment difference between Lamotrigine Extended-Release Tablets and placebo≥2%) in either the titration or maintenance phases of the trial.