Erenumab-Aooe side effects: what 54,776 FDA adverse event reports show
Drug class
Calcitonin gene-related peptide receptor antagonist
Brand names
Aimovig
Who reports
54,776 reports · 21% serious · 2,964 with death outcome · 86% female
Used for
AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. ( 1 )
What it is
Erenumab-aooe is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the calcitonin gene-related peptide receptor. Erenumab-aooe is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,033 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hepatic enzyme | 79 | 504.5 360.1–706.7ROR 505.2 · calibrated p 2e-13 ✓ | 205.5 EB05 170.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=79 · 100% clinician | not reported in cached trials |
| Hypocholesterolaemia | 139 | 317.4 253.3–397.7ROR 318.2 · calibrated p 1e-11 ✓ | 168.8 EB05 146.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=139 · 96% clinician | not reported in cached trials |
| Facet joint syndrome | 863 | 144.6 133.7–156.3ROR 146.9 · calibrated p 6e-9 ✓ | 104.5 EB05 98.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=863 · 93% clinician | not reported in cached trials |
| Peripheral venous disease | 800 | 95.9 88.8–103.6ROR 97.3 · calibrated p 1e-7 ✓ | 76.5 EB05 72.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=800 · 93% clinician | not reported in cached trials |
| Neovascularisation | 50 | 92.8 68.1–126.4ROR 92.9 · calibrated p 4e-7 ✓ | 72.7 EB05 57.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=50 · 100% clinician | not reported in cached trials |
| Onychomadesis | 741 | 83.1 76.8–89.9ROR 84.2 · calibrated p 4e-7 ✓ | 68.1 EB05 64.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=741 · 94% clinician | not reported in cached trials |
| Blepharospasm | 1,005 | 74.0 69.2–79.1ROR 75.3 · calibrated p 9e-7 ✓ | 61.9 EB05 58.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=988 · 92% clinician | not reported in cached trials |
| Rheumatic fever | 694 | 72.3 66.7–78.3ROR 73.2 · calibrated p 1e-6 ✓ | 60.7 EB05 57.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=694 · 93% clinician | not reported in cached trials |
| Device difficult to use | 10,107 | 69.1 67.8–70.5ROR 84.5 · calibrated p 4e-7 ✓ | 58.5 EB05 57.6 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 87.0 · serious PRR 49.8 | not reported in cached trials |
| Breast cancer stage iii | 937 | 65.2 60.9–69.9ROR 66.3 · calibrated p 2e-6 ✓ | 55.7 EB05 52.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=937 · 93% clinician | not reported in cached trials |
| Lupus vulgaris | 171 | 64.2 54.6–75.4ROR 64.4 · calibrated p 3e-6 ✓ | 54.7 EB05 48.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=171 · 91% clinician | not reported in cached trials |
| Incorrect disposal of product | 453 | 63.0 57.0–69.5ROR 63.5 · calibrated p 3e-6 ✓ | 54.0 EB05 49.9 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=33 | not reported in cached trials |
| Overlap syndrome | 96 | 61.8 49.8–76.7ROR 61.9 · calibrated p 4e-6 ✓ | 52.7 EB05 44.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=96 · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 961 | 59.8 55.9–64.0ROR 60.9 · calibrated p 4e-6 ✓ | 51.7 EB05 49.0 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 139.2 · 93% clinician | not reported in cached trials |
| Intercepted product administration error | 1,021 | 58.3 54.6–62.2ROR 59.4 · calibrated p 5e-6 ✓ | 50.6 EB05 48.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Vascular malformation | 28 | 58.0 38.9–86.3ROR 58.0 · calibrated p 1e-5 ✓ | 48.8 EB05 35.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 894 | 53.0 49.5–56.8ROR 53.9 · calibrated p 9e-6 ✓ | 46.6 EB05 44.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 124.8 · 92% clinician | not reported in cached trials |
| Onychomycosis | 512 | 50.6 46.2–55.5ROR 51.1 · calibrated p 1e-5 ✓ | 44.7 EB05 41.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=512 · 95% clinician | not reported in cached trials |
| Paranasal cyst | 27 | 48.4 32.4–72.3ROR 48.5 · calibrated p 3e-5 ✓ | 41.9 EB05 30.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Folliculitis | 1,151 | 47.9 45.1–51.0ROR 49.0 · calibrated p 2e-5 ✓ | 42.6 EB05 40.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 134.1 · 95% clinician | not reported in cached trials |
| Occupational exposure to product | 713 | 47.4 43.9–51.2ROR 48.0 · calibrated p 2e-5 ✓ | 42.2 EB05 39.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Finger deformity | 527 | 46.6 42.6–51.0ROR 47.1 · calibrated p 2e-5 ✓ | 41.5 EB05 38.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=526 · 92% clinician | not reported in cached trials |
| Muscle injury | 891 | 46.6 43.5–49.9ROR 47.3 · calibrated p 2e-5 ✓ | 41.5 EB05 39.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 120.3 · 94% clinician | not reported in cached trials |
| Nail disorder | 923 | 45.4 42.5–48.6ROR 46.2 · calibrated p 2e-5 ✓ | 40.6 EB05 38.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=917 · 93% clinician | not reported in cached trials |
| Dislocation of vertebra | 236 | 45.4 39.6–51.9ROR 45.6 · calibrated p 3e-5 ✓ | 40.5 EB05 36.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=236 · 92% clinician | not reported in cached trials |
| Post-traumatic headache | 16 | 44.3 26.4–74.4ROR 44.3 · calibrated p 8e-5 ✓ | 38.1 EB05 24.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Accidental exposure to product | 10,201 | 43.5 42.7–44.3ROR 53.2 · calibrated p 9e-6 ✓ | 39.1 EB05 38.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 48.9 · serious PRR 22.2 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 54 | 42.0 31.7–55.7ROR 42.1 · calibrated p 5e-5 ✓ | 37.5 EB05 29.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=54 | not reported in cached trials |
| Deep vein thrombosis postoperative | 193 | 41.7 36.0–48.4ROR 41.9 · calibrated p 4e-5 ✓ | 37.5 EB05 33.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=193 | not reported in cached trials |
| Vestibular migraine | 23 | 41.7 27.1–64.1ROR 41.7 · calibrated p 9e-5 ✓ | 36.6 EB05 25.7 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 · 74% consumer | not reported in cached trials |
| Lip dry | 845 | 39.8 37.1–42.7ROR 40.4 · calibrated p 5e-5 ✓ | 36.1 EB05 34.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=841 · 94% clinician | not reported in cached trials |
| Pemphigus | 1,171 | 39.7 37.4–42.2ROR 40.6 · calibrated p 5e-5 ✓ | 36.0 EB05 34.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 97.0 · 94% clinician | not reported in cached trials |
| Helicobacter infection | 914 | 37.6 35.2–40.3ROR 38.3 · calibrated p 7e-5 ✓ | 34.3 EB05 32.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 97.2 · 92% clinician | not reported in cached trials |
| Wound infection | 965 | 37.2 34.9–39.8ROR 37.9 · calibrated p 7e-5 ✓ | 34.0 EB05 32.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 97.7 · 93% clinician | not reported in cached trials |
| Bursitis | 1,057 | 36.7 34.5–39.1ROR 37.4 · calibrated p 8e-5 ✓ | 33.5 EB05 31.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 105.8 · 94% clinician | not reported in cached trials |
| Drug dose omission by device | 6,655 | 36.4 35.5–37.2ROR 41.3 · calibrated p 4e-5 ✓ | 33.3 EB05 32.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 67.0 · serious n=277 · 75% consumer | not reported in cached trials |
| Injection site indentation | 177 | 36.3 31.2–42.4ROR 36.5 · calibrated p 1e-4 ✓ | 33.1 EB05 29.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| C-reactive protein abnormal | 556 | 36.3 33.3–39.6ROR 36.7 · calibrated p 9e-5 ✓ | 33.2 EB05 30.9 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=556 · 92% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 173 | 35.9 30.7–41.9ROR 36.0 · calibrated p 1e-4 ✓ | 32.7 EB05 28.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=173 · 93% clinician | not reported in cached trials |
| Hypercholesterolaemia | 819 | 35.8 33.3–38.4ROR 36.3 · calibrated p 9e-5 ✓ | 32.7 EB05 30.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 93.4 · 93% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Liver injury | 1,645 | 2.12.0–2.2 | raised |
| Depression | 1,460 | 2.01.9–2.1 | raised |
| Hyperglycaemia / diabetes | 1,156 | 1.31.2–1.4 | raised |
| Interstitial lung disease | 299 | 1.21.1–1.3 | raised |
| Fall / fracture | 924 | 0.90.9–1.0 | lower than other drugs |
| Serious infection | 1,382 | 0.70.6–0.7 | lower than other drugs |
| Pancreatitis | 108 | 0.50.4–0.6 | lower than other drugs |
| Seizure | 227 | 0.40.4–0.5 | lower than other drugs |
| Stroke | 285 | 0.40.4–0.5 | lower than other drugs |
| Extrapyramidal | 113 | 0.40.3–0.5 | lower than other drugs |
| Anaphylaxis / angioedema | 134 | 0.40.3–0.5 | lower than other drugs |
| Suicidality | 221 | 0.30.3–0.4 | lower than other drugs |
| Rhabdomyolysis / myopathy | 65 | 0.30.2–0.4 | lower than other drugs |
| Myocardial infarction | 160 | 0.30.3–0.3 | lower than other drugs |
| Opportunistic infection | 105 | 0.30.2–0.4 | lower than other drugs |
| Arrhythmia / qt | 117 | 0.20.2–0.3 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Erenumab-Aooe as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT04465357 — Efficacy of Erenumab on Functional Impact of Migraine (N=55, PHASE4; 1 AE terms posted; arms: Erenumab-Aooe 140 MG/ML [Aimovig])
- NCT04884763 — Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder (N=30, PHASE2; 26 AE terms posted; arms: Arm A; Arm B)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Accidental exposure to product | 10,201 | 43.5 42.7–44.3ROR 53.2 · calibrated p 9e-6 ✓ | 39.1 EB05 38.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 48.9 · serious PRR 22.2 | not reported in cached trials |
| Device difficult to use | 10,107 | 69.1 67.8–70.5ROR 84.5 · calibrated p 4e-7 ✓ | 58.5 EB05 57.6 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 87.0 · serious PRR 49.8 | not reported in cached trials |
| Wrong technique in product usage process | 9,499 | 18.9 18.5–19.2ROR 22.6 · calibrated p 0.001 ✓ | 18.0 EB05 17.7 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 32.5 · serious PRR 10.0 | not reported in cached trials |
| Drug dose omission by device | 6,655 | 36.4 35.5–37.2ROR 41.3 · calibrated p 4e-5 ✓ | 33.3 EB05 32.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 67.0 · serious n=277 · 75% consumer | not reported in cached trials |
| Migraine | 5,201 | 22.2 21.6–22.8ROR 24.4 · calibrated p 8e-4 ✓ | 21.0 EB05 20.5 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 18.0 · serious PRR 49.9 | not reported in cached trials |
| Drug ineffective (drug did not work) | 4,424 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.516 | 1.3 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 4.0 | not reported in cached trials |
| Headache | 3,501 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.939 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.0 · serious PRR 5.9 | NCT04884763: 1/15 (6.7%) on Erenumab-Aooe |
| Constipation | 3,184 | 5.7 5.5–5.9ROR 6.0 · calibrated p 0.150 | 5.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.6 · serious PRR 7.1 | NCT04465357: 3/55 (5.5%) on Erenumab-Aooe |
| Product storage error | 2,976 | 13.6 13.1–14.1ROR 14.3 · calibrated p 0.008 ✓ | 13.2 EB05 12.8 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 16.5 · serious PRR 11.8 | not reported in cached trials |
| Injection site pain (pain where injected) | 2,895 | 3.7 3.5–3.8ROR 3.8 · calibrated p 0.411 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.5 · serious PRR 4.9 | NCT04884763: 1/15 (6.7%) on Erenumab-Aooe |
| Off label use (used outside approved label) | 2,830 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.483 | 1.2 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 4.3 | not reported in cached trials |
| Nausea | 2,480 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.449 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | age-adj. PRR 1.1 · serious PRR 3.9 | NCT04884763: 3/15 (20.0%) on Erenumab-Aooe |
| Fatigue (tiredness) | 2,342 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.414 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | age-adj. PRR 1.1 · serious PRR 3.7 | not reported in cached trials |
| Alopecia (hair loss) | 2,264 | 4.4 4.3–4.6ROR 4.6 · calibrated p 0.284 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.7 · serious PRR 13.9 | not reported in cached trials |
| Pain | 2,003 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.478 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 4.2 | NCT04884763: 1/15 (6.7%) on Erenumab-Aooe |
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.
- Hepatic enzyme — n=79, PRR 504.5
- Hypocholesterolaemia — n=139, PRR 317.4
- Facet joint syndrome — n=863, PRR 144.6
- Peripheral venous disease — n=800, PRR 95.9
- Neovascularisation — n=50, PRR 92.8
- Onychomadesis — n=741, PRR 83.1
- Blepharospasm — n=1,005, PRR 74.0
- Rheumatic fever — n=694, PRR 72.3
- Breast cancer stage iii — n=937, PRR 65.2
- Lupus vulgaris — n=171, PRR 64.2
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 Erenumab-Aooe?
In FDA FAERS, the most frequently co-reported reaction terms for Erenumab-Aooe are drug dose omission by device, migraine, headache, constipation, injection site pain, nausea. 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 Erenumab-Aooe have an FDA boxed warning?
No. The FDA label retrieved for Erenumab-Aooe has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Erenumab-Aooe 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 b998ed05-94b0-47fd-b28f-cddd1e128fd8, effective 20260714; matched on
openfda.generic_name.exact:"ERENUMAB-AOOE") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,073 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
ERENUMAB-AOOE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.