What the label lists and what reports show
Atogepant side effects
Atogepant's FDA label: “The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.” FAERS holds 6,568 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 headache (642 reports).
- No generic listed
Check it at the source: the atogepant FDA label on DailyMed (effective September 30, 2025, AbbVie Inc.); 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 QULIPTA ?QULIPTA can cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: • swelling of the face, lips, or tongue • trouble breathing • rash itching hives High blood pressure: High blood pressure or worsening of high blood pressure can happen when you take QULIPTA. Contact your healthcare provider if you have an increase in blood pressure. Raynaud’s phenomenon: A type of circulation problem can worsen or happen when you take QULIPTA. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur. […]
Source: FDA drug label, AbbVie Inc., effective September 30, 2025 (SPL set 8c8ab8f4-32bd-497a-befa-70c8a51d8d52), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
Table 2: Adverse Reactions Occurring with an Incidence of At Least 2% for QULIPTA and Greater than Placebo in Studies 1, 2, and 3 *
| Reaction | Placebo (N= 663 ) % | QULIPTA 10 mg (N=314) % | QULIPTA 30 mg (N=411) % | QULIPTA 60 mg (N= 678 ) % |
|---|---|---|---|---|
| Nausea | 3 | 5 | 6 | 9 |
| Constipation | 2 | 6 | 6 | 8 |
| Fatigue/Somnolence | 4 | 4 | 4 | 5 |
| Decreased Appetite | <1 | 2 | 1 | 3 |
| Dizziness | 2 | 2 | 2 | 3 |
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: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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. The safety of QULIPTA was evaluated in 2657 patients with migraine who received at least one dose of QULIPTA. Of these, 1225 patients were exposed to QULIPTA for at least 6 months, and 826 patients were exposed for 12 months. In the 12-week, placebo-controlled clinical studies (Studies 1, 2, and 3), 314 patients received at least one dose of QULIPTA 10 mg once daily, 411 patients received at least one dose of QULIPTA 30 mg once daily, 678 patients received at least one dose of QULIPTA 60 mg once daily, and 663 patients received placebo [see Clinical Studies ( 14 ) ]. …
Source: FDA drug label, AbbVie Inc., effective September 30, 2025 (SPL set 8c8ab8f4-32bd-497a-befa-70c8a51d8d52), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,568 reports list atogepant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 76 are coded as a death and 590 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. Reports rose sharply in 2023 (1,716, against a median of 8 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 8 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?
- Atogepant: 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