Emgalitygalcanezumab
30,356 adverse event reports submitted to the FDA (2015–2026)
Top Reported Adverse Events
The most frequently reported events in association with Emgality in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Injection Site Pain 7,207 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Migraine 2,963 reports
A severe, often throbbing headache, sometimes with nausea or sensitivity to light and sound.
Full definition in the glossary → See all drugs reporting this event →Underdose 2,915 reports
A report that less of a medication was taken than prescribed. This is a usage category.
Full definition in the glossary →Headache 2,384 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,915 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Product Dose Omission Issue 1,731 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Injection Site Haemorrhage 1,547 reports
Bleeding at the spot where a medication was injected. Also spelled hemorrhage in American English.
Full definition in the glossary →Injection Site Erythema 1,111 reports
Redness of the skin at the spot where a medication was injected. Erythema means skin redness.
Full definition in the glossary →Accidental Underdose 1,068 reports
A report that less of a medication was taken than intended, by accident. This is a usage category.
Full definition in the glossary →Incorrect Dose Administered 953 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →- Injection Site Pruritus 806 reports
Nausea 804 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Injection Site Swelling 798 reports
Swelling at the spot where a medication was injected.
Full definition in the glossary →Fatigue 736 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Injection Site Reaction 720 reports
A general report of a reaction at the spot where a medication was injected, such as redness, swelling, or pain.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 23,520 |
| Male | 3,485 |
| Unknown | 4 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 114 |
| 18-34 | 2,802 |
| 35-49 | 4,475 |
| 50-64 | 4,389 |
| 65-74 | 1,344 |
| 75+ | 438 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Emgality. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 26,649 |
| Other Serious | 2,621 |
| Hospitalization | 1,073 |
| Disability | 299 |
| Life-Threatening | 91 |
| Death | 81 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Emgality. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2015 | 4 |
| 2016 | 4 |
| 2017 | 5 |
| 2018 | 140 |
| 2019 | 4,657 |
| 2020 | 6,640 |
| 2021 | 4,645 |
| 2022 | 3,737 |
| 2023 | 2,977 |
| 2024 | 3,150 |
| 2025 | 3,667 |
| 2026 (partial) | 730 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026