Galcanezumab-Gnlm side effects: what 31,307 FDA adverse event reports show

Galcanezumab-Gnlm · Emgality · 1,008 reaction terms · 67,867 drug–reaction co-reports · data 2026-09-14

Drug class

Calcitonin-gene related peptide antagonist

FDA label, Indications wording

Brand names

Emgality

openFDA label

Who reports

31,307 reports · 12% serious · 85 with death outcome · 87% female

openFDA FAERS counts, all years, deduplication not applied

Used for

EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 ) 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.

FDA label, Indications and Usage

What it is

Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 4Labeled (related wording) 14Likely indication confounding 4Reporting / coding artifact 7Not in label — unassessed 11

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 968 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Incorrect product formulation administered	96	86.2 69.7–106.6ROR 86.4 · χ² 7,074 / p <1e-300	75.2 EB05 63.4 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious n=3 · 88% consumer	no trial arm names this drug
Cluster headache	133	72.5 60.7–86.7ROR 72.8 · χ² 8,390 / p <1e-300	64.9 EB05 56.1 · IC025 +5.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=24 · ♀ 54% (drug 87%) · 90% consumer	no trial arm names this drug
Incorrect product dosage form administered	35	63.8 45.1–90.2ROR 63.9 · χ² 1,916 / p <1e-300	56.6 EB05 42.5 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	89% consumer	no trial arm names this drug
Accidental underdose	1,068	53.0 49.8–56.3ROR 54.8 · χ² 50,402 / p <1e-300	49.1 EB05 46.7 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=11 · 88% consumer	no trial arm names this drug
Hemiplegic migraine	18	38.6 24.0–62.0ROR 38.6 · χ² 587 / p 5e-130	35.3 EB05 23.6 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	no trial arm names this drug
Underdose	2,917	27.8 26.9–28.8ROR 30.6 · χ² 72,597 / p <1e-300	26.7 EB05 25.9 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.2 · 85% consumer	no trial arm names this drug
Injection site injury	195	24.7 21.4–28.4ROR 24.8 · χ² 4,246 / p <1e-300	23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious n=3 · 97% consumer	no trial arm names this drug
Migraine	3,057	22.3 21.5–23.1ROR 24.6 · χ² 60,337 / p <1e-300	21.6 EB05 20.9 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 27.9 · 90% consumer	no trial arm names this drug
Wrong schedule	30	21.8 15.2–31.4ROR 21.8 · χ² 557 / p 2e-123	20.9 EB05 15.3 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	93% consumer	no trial arm names this drug
Occipital neuralgia	17	20.9 12.9–33.8ROR 20.9 · χ² 292 / p 7e-66	19.7 EB05 12.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=6	no trial arm names this drug
Injection site pain (pain where injected)	7,524	17.0 16.7–17.3ROR 22.1 · χ² 112,086 / p <1e-300	16.6 EB05 16.3 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.4 · 93% consumer	no trial arm names this drug
Medication overuse headache	21	16.8 10.9–26.0ROR 16.8 · χ² 290 / p 3e-65	16.0 EB05 10.7 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	90% consumer	no trial arm names this drug
Intercepted product prescribing error	31	16.4 11.5–23.4ROR 16.4 · χ² 422 / p 4e-94	15.8 EB05 11.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Incorrect dose administered by device	577	15.5 14.3–16.9ROR 15.8 · χ² 7,669 / p <1e-300	15.2 EB05 14.2 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=7 · 92% consumer	no trial arm names this drug
Injection site discomfort	221	14.6 12.8–16.7ROR 14.7 · χ² 2,733 / p <1e-300	14.3 EB05 12.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=4 · 94% consumer	no trial arm names this drug
Injection site urticaria	512	14.4 13.2–15.7ROR 14.6 · χ² 6,253 / p <1e-300	14.1 EB05 13.1 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=17 · 81% consumer	no trial arm names this drug
Therapeutic response shortened	660	14.2 13.1–15.3ROR 14.4 · χ² 7,904 / p <1e-300	13.9 EB05 13.0 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.2 · 86% consumer	no trial arm names this drug
Injection site hypersensitivity	63	14.0 10.9–18.0ROR 14.0 · χ² 732 / p 2e-161	13.6 EB05 10.9 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=5 · 86% consumer	no trial arm names this drug
Aura	38	13.9 10.1–19.2ROR 14.0 · χ² 435 / p 8e-97	13.4 EB05 10.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=10 · 87% consumer	no trial arm names this drug
Injection site haemorrhage	1,608	13.8 13.2–14.5ROR 14.5 · χ² 18,814 / p <1e-300	13.6 EB05 13.0 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.3 · 94% consumer	no trial arm names this drug
Injection site coldness	16	13.1 8.0–21.4ROR 13.1 · χ² 163 / p 1e-37	11.8 EB05 7.1 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	–	no trial arm names this drug
Migraine with aura	44	11.0 8.2–14.8ROR 11.0 · χ² 385 / p 6e-86	10.5 EB05 8.0 · IC025 +2.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=9 · 86% consumer	no trial arm names this drug
Intercepted product dispensing error	26	10.9 7.4–16.0ROR 10.9 · χ² 220 / p 4e-50	10.0 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Injection site mass	510	9.4 8.6–10.2ROR 9.5 · χ² 3,764 / p <1e-300	9.2 EB05 8.6 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.9 · 86% consumer	no trial arm names this drug
Prescribed underdose	263	8.9 7.9–10.1ROR 9.0 · χ² 1,823 / p <1e-300	8.8 EB05 7.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · 92% consumer	no trial arm names this drug
Intercepted product selection error	16	8.6 5.3–14.1ROR 8.6 · χ² 99 / p 1e-23	7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Injection site pruritus	817	8.3 7.8–8.9ROR 8.5 · χ² 5,199 / p <1e-300	8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.6 · 81% consumer	no trial arm names this drug
Injection site paraesthesia	18	8.1 5.1–12.9ROR 8.1 · χ² 103 / p 1e-24	6.9 EB05 4.5 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	–	no trial arm names this drug
Fear of injection	80	7.8 6.2–9.7ROR 7.8 · χ² 459 / p 5e-102	7.4 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=6 · 92% consumer	no trial arm names this drug
Injury associated with device	223	7.5 6.6–8.6ROR 7.5 · χ² 1,236 / p 4e-271	7.3 EB05 6.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=3 · 91% consumer	no trial arm names this drug
Device dispensing error	13	7.4 4.3–12.9ROR 7.4 · χ² 65 / p 3e-16	6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Injection site swelling	809	7.2 6.7–7.7ROR 7.4 · χ² 4,296 / p <1e-300	7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.2 · 83% consumer	no trial arm names this drug
Injection site rash	324	7.2 6.5–8.0ROR 7.3 · χ² 1,713 / p <1e-300	7.1 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious n=20 · 75% consumer	no trial arm names this drug
Mast cell activation syndrome	14	7.1 4.2–12.1ROR 7.1 · χ² 67 / p 1e-16	5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Injection site reaction	724	7.1 6.6–7.7ROR 7.3 · χ² 3,782 / p <1e-300	7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.1 · 73% consumer	no trial arm names this drug
Injection site warmth	208	6.8 6.0–7.8ROR 6.9 · χ² 1,018 / p 1e-223	6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious n=10 · 85% consumer	no trial arm names this drug
Postural orthostatic tachycardia syndrome	13	6.7 3.9–11.6ROR 6.7 · χ² 57 / p 2e-14	5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Injection site scar	26	6.2 4.2–9.2ROR 6.2 · χ² 108 / p 1e-25	5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	92% consumer	no trial arm names this drug
Injection site vesicles	55	6.2 4.7–8.1ROR 6.2 · χ² 232 / p 1e-52	5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious n=3 · 87% consumer	no trial arm names this drug
Injection site erythema (redness where injected)	1,128	6.2 5.8–6.5ROR 6.4 · χ² 4,862 / p <1e-300	6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4 · 82% consumer	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Galcanezumab-Gnlm (searched GALCANEZUMAB-GNLM).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Injection site pain (pain where injected)	7,524	17.0 16.7–17.3ROR 22.1 · χ² 112,086 / p <1e-300	16.6 EB05 16.3 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.4 · 93% consumer	no trial arm names this drug
Migraine	3,057	22.3 21.5–23.1ROR 24.6 · χ² 60,337 / p <1e-300	21.6 EB05 20.9 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 27.9 · 90% consumer	no trial arm names this drug
Underdose	2,917	27.8 26.9–28.8ROR 30.6 · χ² 72,597 / p <1e-300	26.7 EB05 25.9 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.2 · 85% consumer	no trial arm names this drug
Headache	2,448	2.6 2.5–2.7ROR 2.8 · χ² 2,526 / p <1e-300	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 2.7 · 89% consumer	no trial arm names this drug
Drug ineffective (drug did not work)	1,955	1.0 1.0–1.0ROR 1.0 · χ² 0 / p 0.403	1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.1 · 84% consumer	no trial arm names this drug
Product dose omission issue	1,748	4.1 3.9–4.3ROR 4.3 · χ² 4,176 / p <1e-300	4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4 · 92% consumer	no trial arm names this drug
Injection site haemorrhage	1,608	13.8 13.2–14.5ROR 14.5 · χ² 18,814 / p <1e-300	13.6 EB05 13.0 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.3 · 94% consumer	no trial arm names this drug
Injection site erythema (redness where injected)	1,128	6.2 5.8–6.5ROR 6.4 · χ² 4,862 / p <1e-300	6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4 · 82% consumer	no trial arm names this drug
Incorrect dose administered	1,069	3.2 3.0–3.4ROR 3.3 · χ² 1,618 / p <1e-300	3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 86% consumer	no trial arm names this drug
Accidental underdose	1,068	53.0 49.8–56.3ROR 54.8 · χ² 50,402 / p <1e-300	49.1 EB05 46.7 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=11 · 88% consumer	no trial arm names this drug
Nausea	826	0.7 0.7–0.7ROR 0.7 · χ² 109 / p 7e-26	0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.9 · 82% consumer	no trial arm names this drug
Injection site pruritus	817	8.3 7.8–8.9ROR 8.5 · χ² 5,199 / p <1e-300	8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.6 · 81% consumer	no trial arm names this drug
Injection site swelling	809	7.2 6.7–7.7ROR 7.4 · χ² 4,296 / p <1e-300	7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.2 · 83% consumer	no trial arm names this drug
Fatigue (tiredness)	767	0.7 0.6–0.7ROR 0.7 · χ² 138 / p 3e-32	0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.7 · 84% consumer	no trial arm names this drug
Injection site reaction	724	7.1 6.6–7.7ROR 7.3 · χ² 3,782 / p <1e-300	7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.1 · 73% consumer	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Accidental underdose — n=1,068, PRR 53.0
Intercepted product prescribing error — n=31, PRR 16.4
Aura — n=38, PRR 13.9
Intercepted product dispensing error — n=26, PRR 10.9
Prescribed underdose — n=263, PRR 8.9
Fear of injection — n=80, PRR 7.8
Injury associated with device — n=223, PRR 7.5

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Galcanezumab-Gnlm?

In FDA FAERS, the most frequently co-reported reaction terms for Galcanezumab-Gnlm are injection site pain, migraine, headache, injection site haemorrhage, injection site erythema, accidental underdose. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Galcanezumab-Gnlm have an FDA boxed warning?

No. The FDA label retrieved for Galcanezumab-Gnlm has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Galcanezumab-Gnlm causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 33a147be-233a-40e8-a55e-e40936e28db0, effective 20260605; matched on openfda.generic_name.exact:"GALCANEZUMAB-GNLM")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,008 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query GALCANEZUMAB-GNLM, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.