Lasmiditan Side Effects
Applies to lasmiditan: oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Check with your doctor if you used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often.
Lasmiditan may cause drowsiness or dizziness. Wait at least 8 hours after taking lasmiditan before you drive, use machines, or do anything else that requires you to be alert.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with lasmiditan may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Using lasmiditan alone or in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record your headache frequency and drug use.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of lasmiditan
Along with its needed effects, lasmiditan 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 lasmiditan:
More common side effects
- dizziness
- drowsiness
- relaxed and calm
- sleepiness
Less common side effects
- irregular heartbeat
- trouble breathing
Rare side effects
- fast heartbeat
- fever
- hives, itching, rash
- hoarseness
- irritation
- joint pain, stiffness or swelling
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled swallowing
Incidence not known
- anxiety
- confusion
- diarrhea
- difficulty sleeping
- disorientation
- drowsiness to profound coma
- dry mouth
- fever
- headache
- hyperventilation
- irritability
- lightheadedness
- nervousness
- overactive reflexes
- poor coordination
- restlessness
- seeing, hearing, or feeling things that are not there
- shivering
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- unusual tiredness or weakness
Other side effects of lasmiditan
Some side effects of lasmiditan 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 side effects
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
Less common side effects
- false or unusual sense of well-being
- feeling of constant movement of self or surroundings
- muscle spasm
- sensation of spinning
- trouble seeing
For healthcare professionals
Applies to lasmiditan: oral tablet.
General adverse events
The most commonly reported adverse reactions have included dizziness, fatigue, paresthesia, and sedation.[Ref]
Nervous system
- 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
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.
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity including angioedema, rash and photosensitivity
Cardiovascular
- Frequency not reported: Chest discomfort, palpitations, heart rate decreases, increased blood pressure
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.
Respiratory
- Frequency not reported: Dyspnea
Dyspnea was reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.
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
- Common (1% to 10%): Muscle weakness
- Frequency not reported: Muscle spasm, limb discomfort
Muscle spasm and limb discomfort were reported in less than 2% of patients receiving this drug, but more frequently than those receiving placebo.
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.
See also:
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References
1. (2019) "Product Information. Reyvow (lasmiditan)." Lilly, Eli and Company
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Further information
Lasmiditan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.