Qulipta (Atogepant) Side Effects
The most common side effects of Qulipta are constipation (occurring in 7-11% of patients), nausea (4-10%), and fatigue/sleepiness, with serious allergic reactions being rare but requiring immediate discontinuation. 1, 2, 3
Most Common Adverse Events
Constipation is the most frequently reported side effect, occurring in 6.9-10.9% of patients across all doses (10 mg, 30 mg, 60 mg) compared to 3% with placebo 1, 2, 3
Nausea affects 4.4-10% of patients on atogepant versus 4% on placebo 1, 2, 3
Fatigue and sleepiness are commonly reported but specific incidence rates vary by dose 1
These gastrointestinal and constitutional symptoms are generally mild to moderate in severity and rarely lead to treatment discontinuation 4, 5
Serious Adverse Events
Hypersensitivity reactions, including anaphylaxis, can occur when starting Qulipta or days after initiation 1
Stop Qulipta immediately and seek emergency care if you develop: swelling of face/lips/tongue, itching, trouble breathing, hives, or rash 1
Serious adverse events in clinical trials were rare, including isolated cases of asthma and optic neuritis in the 10 mg dose group 3
No significant differences in serious adverse events were observed between atogepant and placebo groups overall 4
Weight Changes
Clinically significant weight decrease (≥7% reduction) occurred in 6% of patients on both the 30 mg twice daily and 60 mg once daily doses, compared to 2% with placebo 2
This weight loss pattern should be monitored during treatment, particularly in patients where weight loss may be clinically concerning 2
Dose-Related Considerations
The 60 mg once daily dose showed the greatest efficacy for migraine reduction but also the highest incidence of constipation (10%) and nausea (10%) 2, 4
The 30 mg dose (whether once or twice daily) demonstrated a similar side effect profile with slightly lower rates of gastrointestinal symptoms 2, 3
The 10 mg dose had the most favorable tolerability profile but lower efficacy 3
Critical Safety Warnings
Avoid in patients with prior allergic reactions to atogepant or any ingredients in Qulipta 1
Inform your healthcare provider about kidney or liver problems, as dose adjustments may be necessary 1
Drug interactions can occur with certain medications, requiring dose modifications of Qulipta when used with strong CYP3A4 inhibitors or inducers, or OATP inhibitors 1
Pregnancy and breastfeeding safety is unknown; discuss risks and benefits with your provider if you are pregnant, planning pregnancy, or breastfeeding 1
Long-Term Safety Profile
The safety profile of atogepant has been consistent across clinical trials, with most adverse events being mild to moderate 4, 5
Long-term safety data beyond 12 weeks in placebo-controlled studies is still limited, though open-label extension studies are ongoing 5
No hepatotoxicity signals or cardiovascular safety concerns have emerged in trials to date 4, 3