What the label lists and what reports show
Lasmiditan side effects
Lasmiditan's FDA label: “Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation.” FAERS holds 1,143 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (209 reports).
- No generic listed
- A presentation discontinued
- DEA Schedule V
Check it at the source: the lasmiditan FDA label on DailyMed (effective January 8, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of REYVOW?REYVOW can cause serious side effects including: See “ What is the most important information I should know about REYVOW? ” serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using REYVOW, especially if REYVOW is used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma fast heartbeat changes in blood pressure high body temperature tight muscles trouble walking nausea, vomiting, or diarrhea medication overuse headache. Some people who take medicines like REYVOW for the acute treatment of migraine attacks for 10 or more days each month may have worse headaches (medication overuse headache). […]
Source: FDA drug label, Eli Lilly and Company, effective January 8, 2026 (SPL set aea3358c-ff41-4490-9e6d-c7bf7b3de13f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation.
Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2
| Adverse Reaction | REYVOW 50 mg N=654 % | REYVOW 100 mg N=1265 % | REYVOW 200 mg N=1258 % | Placebo N=1262 % |
|---|---|---|---|---|
| Dizziness | 9 | 15 | 17 | 3 |
| Fatigue a | 4 | 5 | 6 | 1 |
| Paresthesia b | 3 | 7 | 9 | 2 |
| Sedation c | 6 | 6 | 7 | 2 |
| Nausea and/or Vomiting | 3 | 4 | 4 | 2 |
| Muscle Weakness | 1 | 1 | 2 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment [see Warnings and Precautions ( 5.1 )] Central Nervous System Depression [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Medication Overuse Headache [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW. In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200 mg [see Clinical Studies ( 14.1 )]. Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity. …
Source: FDA drug label, Eli Lilly and Company, effective January 8, 2026 (SPL set aea3358c-ff41-4490-9e6d-c7bf7b3de13f), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,143 reports list lasmiditan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 58 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lasmiditan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions