65/100 · Elevated
Manufactured by Eli Lilly and Company
Galcanezumab-Gnlm Safety Profile: Injection Site Reactions and Underdose Issues
49,086 FDA adverse event reports analyzed
Last updated: 2026-05-12
GALCANEZUMAB GNLM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. Based on analysis of 49,086 FDA adverse event reports, GALCANEZUMAB GNLM has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for GALCANEZUMAB GNLM include INJECTION SITE PAIN, UNDERDOSE, MIGRAINE, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GALCANEZUMAB GNLM.
Galcanezumab-Gnlm has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 49,086 adverse event reports for this medication, which is primarily manufactured by Eli Lilly And Company.
The most commonly reported adverse events include Injection Site Pain, Underdose, Migraine. Of classified reports, 12.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Injection site pain and erythema are the most common adverse events, with a significant number of reports of underdose and incorrect dose administration.
Serious adverse events account for 12.1% of the total, with injection site hemorrhage and pruritus being notable. The majority of adverse events are non-serious, but the high volume of reports indicates a need for careful monitoring. Weight increase and constipation are also frequently reported, suggesting potential side effects on metabolism and gastrointestinal function.
Patients taking Galcanezumab-Gnlm should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but patients should be cautious with devices used for administration and follow prescribed dosing instructions to avoid underdose or overdose. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Galcanezumab-Gnlm received a safety concern score of 65/100 (elevated concern). This is based on a 12.1% serious event ratio across 29,603 classified reports. The score accounts for 49,086 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 22,909, Male: 3,389, Unknown: 4. The most frequently reported age groups are age 45 (370 reports), age 50 (346 reports), age 49 (334 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,603 classified reports for GALCANEZUMAB GNLM:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
No specific drug interactions are noted, but patients should be cautious with devices used for administration and follow prescribed dosing instructions to avoid underdose or overdose.
If you are taking Galcanezumab-Gnlm, here are important things to know. The most commonly reported side effects include injection site pain, underdose, migraine, headache, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for injection site reactions and report any unusual symptoms to your healthcare provider. Ensure proper administration technique to avoid underdose or overdose. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Galcanezumab-Gnlm. Patients should report any adverse events to their healthcare provider and adhere to the prescribed dosing schedule.
The FDA has received approximately 49,086 adverse event reports associated with Galcanezumab-Gnlm. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Galcanezumab-Gnlm include Injection Site Pain, Underdose, Migraine, Headache, Drug Ineffective. By volume, the top reported reactions are: Injection Site Pain (6,969 reports), Underdose (2,915 reports), Migraine (2,888 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Galcanezumab-Gnlm.
Out of 29,603 classified reports, 3,571 (12.1%) were classified as serious and 26,032 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Galcanezumab-Gnlm break down by patient sex as follows: Female: 22,909, Male: 3,389, Unknown: 4. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Galcanezumab-Gnlm adverse events are: age 45: 370 reports, age 50: 346 reports, age 49: 334 reports, age 54: 321 reports, age 55: 310 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Galcanezumab-Gnlm adverse event reports is Eli Lilly And Company. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Galcanezumab-Gnlm include: Product Dose Omission Issue, Injection Site Haemorrhage, Injection Site Erythema, Accidental Underdose, Incorrect Dose Administered. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Galcanezumab-Gnlm to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Galcanezumab-Gnlm has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Injection site pain and erythema are the most common adverse events, with a significant number of reports of underdose and incorrect dose administration.
Key safety signals identified in Galcanezumab-Gnlm's adverse event data include: Injection site pain and erythema. Underdose and incorrect dose administration. Serious adverse events including injection site hemorrhage and pruritus. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but patients should be cautious with devices used for administration and follow prescribed dosing instructions to avoid underdose or overdose. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Galcanezumab-Gnlm.
Monitor for injection site reactions and report any unusual symptoms to your healthcare provider. Ensure proper administration technique to avoid underdose or overdose.
Galcanezumab-Gnlm has 49,086 adverse event reports on file with the FDA. Serious adverse events account for 12.1% of the total, with injection site hemorrhage and pruritus being notable. The volume of reports for Galcanezumab-Gnlm reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Galcanezumab-Gnlm. Patients should report any adverse events to their healthcare provider and adhere to the prescribed dosing schedule. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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