Applies to lasmiditan: oral tablets.

Side effects include:

Adverse effects (≥5%): Dizziness, fatigue, paresthesia, sedation.

For Healthcare Professionals

Applies to lasmiditan: oral tablet.

General

The most commonly reported adverse reactions have included dizziness, fatigue, paresthesia, and sedation.^[Ref]

Nervous system

Vertigo, incoordination, lethargy, tremor, cognitive changes, and speech abnormalities were reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.

In a clinical study evaluating driving performance 90 minutes after administration of this drug, a dose-dependent impairment of computer-based simulated driving performance was observed.

Very common (10% or more): Dizziness (up to 17%)

Common (1% to 10%): Sedation (includes somnolence), paresthesia (includes oral paresthesia, oral hypoesthesia, and hypoesthesia)

Frequency not reported: Vertigo, incoordination, lethargy, tremor, cognitive changes, speech abnormalities, impaired driving performance, serotonin syndrome

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity including angioedema, rash and photosensitivity

Cardiovascular

Chest discomfort and palpitations were reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo. A mean decrease in heart rate of 5 to 10 beats per minute was observed in patients receiving this drug, while a mean decrease of 2 to 5 beats per minute was observed in placebo patients. Blood pressure increases of 2 to 3 mmHg were observed in patients receiving 200 mg of this drug compared to a mean increase of up to 1 mmHg in placebo patients. In healthy patients over 65 years, a mean increase of 7 mmHg was observed in patients receiving this drug compared with 4 mmHg in placebo patients. By 2 hours, no difference in blood pressure compared to placebo were found. This drug has not been well studied in patients with ischemic heart disease.

Frequency not reported: Chest discomfort, palpitations, heart rate decreases, increased blood pressure

Respiratory

Dyspnea was reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.

Frequency not reported: Dyspnea

Ocular

Frequency not reported: Visual impairment

Visual impairment was reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.

Other

Common (1% to 10%): Fatigue (includes asthenia and malaise)

Gastrointestinal

Common (1% to 10%): Nausea and/or vomiting

Musculoskeletal

Muscle spasm and limb discomfort were reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.

Common (1% to 10%): Muscle weakness

Frequency not reported: Muscle spasm, limb discomfort

Psychiatric

Frequency not reported: Feeling abnormal, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, confusion, euphoric mood, hallucinations

Feeling abnormal, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, confusion, euphoric mood, and hallucinations were reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.