Atogepant: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 28, 2026🚩 Report this page

Atogepant

Calcitonin Gene-Related Peptide (Cgrp) Antagonists

Sold as Aquipta · QULIPTA

GB MHRAEU EMACA Health Canada

Drug class: Calcitonin Gene-Related Peptide (Cgrp) Antagonists
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 6

N02CDCalcitonin Gene-Related Peptide (Cgrp) Antagonists

Overview

Atogepant is an active pharmaceutical ingredient in the Calcitonin Gene-Related Peptide (Cgrp) Antagonists group (N02CD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	May 15, 2026
EU European Union	EMA	1	May 28, 2026
CA Canada	Health Canada	3	April 27, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

AQUIPTA is indicated for: • Acute treatment of migraine with or without aura in adults • Prophylaxis of migraine in adults who have at least 4 migraine days per month.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 28, 2026[2]

AQUIPTA is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

How to take

CACanada· Health Canada

3 products

3 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

QULIPTAABBVIE CORPORATION

Sources & citations

[1]MHRA (UK) · PLGB410420089 · revised May 15, 2026
[2]European Medicines Agency · EMEA/H/C/005871 · revised May 28, 2026
[3]Health Canada (DPD) · 02533979 · revised April 27, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

Summary of the safety profile The safety of AQUIPTA was evaluated in 3 852 patients with migraine who received at least one dose of AQUIPTA. Of these, 1 225 patients were exposed to AQUIPTA for prophylaxis daily for at least 6 months and 826 patients were exposed for 12 months.
895 patients were exposed during 24 weeks on an as-needed basis for treatment of acute migraine attacks. In 12-week, placebo-controlled prophylaxis clinical studies, 314 patients received at least one dose of AQUIPTA 10 mg once daily, 411 patients received at least one dose of AQUIPTA 30 mg once daily, 343 patients received at least one dose of AQUIPTA 30 mg twice daily, 678 patients received at least one dose of AQUIPTA 60 mg once daily, 91 patients received at least one dose of AQUIPTA 60 mg twice daily, and 663 patients received placebo.
In the placebo-controlled clinical study for acute treatment of migraine, 1 195 patients received at least one dose of AQUIPTA 60 mg, and 1 177 patients received placebo; patients received both AQUIPTA and placebo to treat qualifying migraines.
In placebo-controlled prophylaxis studies, the most commonly reported adverse reactions were nausea (7%), constipation (7%), and fatigue/somnolence (5%). The majority of the cases were mild, and none were serious. 6%). 3%) was the most commonly reported adverse reaction for acute treatment.
Tabulated list of adverse reactions Table 2 lists adverse reactions for which a causal relationship between AQUIPTA and the adverse event is at least a reasonable possibility. Given the lower exposure in the setting of acute treatment of migraine, adverse drug reactions may not occur or may not be as frequent as when used for the prophylaxis of migraine.
The adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000) or very rare (<1/10 000).
, dyspnoea, rash, pruritus, urticaria, facial oedema) Immune system disorders Rare Anaphylaxis Metabolism and nutrition disorders Common Decreased appetite Gastrointestinal disorders Common Nausea, constipation General disorders and administration site conditions Common Fatigue/somnolence Common Weight decreased Investigations Uncommon ALT/AST increased * Frequency categories are based on once daily administration.
Given the lower exposure in the setting of acute treatment of migraine, adverse drug reactions may not occur or may not be as frequent as when used for the prophylaxis of migraine. 2%). In the placebo-controlled period of the study for acute treatment of migraine, transaminase elevations over 3 times the upper limit of normal were not seen in patients treated with AQUIPTA, though cases with a possible relationship to AQUIPTA were seen in the open-label period.
There were cases with transaminase elevations over 3 times the upper limit of normal that were temporally associated with AQUIPTA treatment; these were asymptomatic and resolved within 8 weeks of discontinuation. There were no cases of severe liver injury or jaundice in these clinical studies.
8% for AQUIPTA 60 mg twice daily. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

8). Some hypersensitivity reactions can occur days after administration. 3). 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This is not medical advice. Consult a qualified healthcare professional.