What the label lists and what reports show
Pitolisant side effects
Pitolisant's FDA label: “Most common adverse reactions (≥5% and at least twice placebo) in adults: insomnia, nausea, and anxiety ( 6.1 ).” FAERS holds 2,067 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 nausea (235 reports).
- No generic listed
Check it at the source: the pitolisant FDA label on DailyMed (effective February 13, 2026, Harmony Biosciences, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5% and at least twice placebo) in adults: insomnia, nausea, and anxiety ( 6.1 ).
Table 1: Adverse Reactions that Occurred in ≥2% of WAKIX-Treated Patients and More Frequently than in Placebo-Treated Patients in Three Placebo-Controlled Narcolepsy Studies
| Adverse Reaction | WAKIX (n=152) % | Placebo (n=114) % |
|---|---|---|
| Headache | 18 | 15 |
| Insomnia | 6 | 2 |
| Nausea | 6 | 3 |
| Upper respiratory tract infection | 5 | 3 |
| Musculoskeletal pain | 5 | 3 |
| Anxiety | 5 | 1 |
| Heart rate increased | 3 | 0 |
| Hallucinations | 3 | 0 |
| Irritability | 3 | 2 |
| Abdominal pain | 3 | 1 |
| Sleep disturbance | 3 | 2 |
| Decreased appetite | 3 | 0 |
| Cataplexy | 2 | 1 |
| Dry mouth | 2 | 1 |
| Rash | 2 | 1 |
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 adverse reactions are discussed in more detail in other sections of the labeling: QT Interval Prolongation [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥5% and at least twice placebo) in adults: insomnia, nausea, and anxiety ( 6.1 ). Most common adverse reactions (≥5% and greater than placebo) in pediatric patients 6 years and older: headache and insomnia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Harmony Biosciences at 1-800-833-7460 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 with Narcolepsy In clinical trials for narcolepsy, 172 adult patients were treated with WAKIX in placebo-controlled trials for up to 8 weeks and in open-label extension trials for up to 5 years. In trials in which WAKIX was directly compared to placebo, 6 of the 152 patients (3.9%) who received WAKIX and 4 of the 114 patients (3.5%) who received placebo discontinued because of an adverse reaction. …
Source: FDA drug label, Harmony Biosciences, LLC, effective February 13, 2026 (SPL set 8daa5562-824e-476c-9652-26ceef3d4b0e), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,067 reports list pitolisant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 234 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 19 reactions below, 9 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?
- Pitolisant: 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