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Drug · FAERS side-effect profile with label screen

Evolocumab side effects: what 161,209 FDA adverse event reports show

Evolocumab · Repatha · 1,176 reaction terms · 368,094 drug–reaction co-reports · data 2026-09-14

Drug class

PCSK9 Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Repatha

openFDA label

Who reports

161,209 reports · 17% serious · 2,035 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.

FDA label, Indications and Usage

What it is

Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.

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 (related wording) 3Likely indication confounding 6Reporting / coding artifact 12Lab value / disease marker 4Not in label — unassessed 15

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). 1,136 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
Fractional exhaled nitric oxide increased	119	291.4 210.4–403.7ROR 291.6 · calibrated p 4e-11 ✓	88.1 EB05 75.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=119 · ♀ 0% (drug 58%)	not reported in cached trials
Incorrect disposal of product	1,683	144.8 135.1–155.3ROR 146.3 · calibrated p 6e-9 ✓	68.2 EB05 65.5 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious n=165 · 79% consumer	not reported in cached trials
Low density lipoprotein decreased	726	137.2 123.5–152.3ROR 137.8 · calibrated p 1e-8 ✓	66.4 EB05 62.5 · IC025 +5.9 3/3 methods agree	Likely indication confounding term in indications	serious n=162 · ♀ 28% (drug 58%)	not reported in cached trials
Device difficult to use	32,925	129.9 128.0–131.8ROR 162.9 · calibrated p 2e-9 ✓	64.8 EB05 64.2 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 154.8 · serious PRR 112.9 · 80% consumer	not reported in cached trials
Intercepted product administration error	2,520	62.9 60.0–66.0ROR 63.9 · calibrated p 3e-6 ✓	42.4 EB05 41.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=80	not reported in cached trials
Low density lipoprotein abnormal	198	61.7 52.0–73.0ROR 61.7 · calibrated p 4e-6 ✓	41.7 EB05 37.1 · IC025 +5.0 3/3 methods agree	Likely indication confounding term in indications	serious n=29	not reported in cached trials
Drug dose omission by device	24,638	61.6 60.7–62.5ROR 72.5 · calibrated p 1e-6 ✓	41.8 EB05 41.4 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	age-adj. PRR 118.8 · serious n=1,351 · 84% consumer	not reported in cached trials
Product communication issue	2,723	61.0 58.3–63.8ROR 62.0 · calibrated p 3e-6 ✓	41.6 EB05 40.3 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious n=223 · 88% consumer	not reported in cached trials
Type iia hyperlipidaemia	69	56.7 42.7–75.3ROR 56.7 · calibrated p 9e-6 ✓	39.1 EB05 32.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=67 · ♀ 0% (drug 58%)	not reported in cached trials
Blood cholesterol decreased	455	41.9 37.7–46.6ROR 42.0 · calibrated p 4e-5 ✓	31.7 EB05 29.4 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=80	not reported in cached trials
Computerised tomogram heart abnormal	18	40.2 23.7–68.3ROR 40.2 · calibrated p 1e-4 ✓	29.9 EB05 20.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Lipoprotein (a) increased	69	39.2 30.0–51.4ROR 39.2 · calibrated p 8e-5 ✓	30.0 EB05 24.5 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications	serious n=22	not reported in cached trials
Lack of administration site rotation	52	27.3 20.2–36.8ROR 27.3 · calibrated p 6e-4 ✓	22.5 EB05 17.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Product knowledge deficit	96	26.6 21.3–33.1ROR 26.6 · calibrated p 6e-4 ✓	22.1 EB05 18.6 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	100% consumer	not reported in cached trials
Accidental exposure to product	16,804	26.2 25.8–26.6ROR 29.1 · calibrated p 3e-4 ✓	21.9 EB05 21.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 29.0 · serious PRR 30.2	not reported in cached trials
Low density lipoprotein increased	1,170	23.2 21.8–24.7ROR 23.3 · calibrated p 1e-3 ✓	19.8 EB05 18.8 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications	serious n=209	not reported in cached trials
Occupational exposure to product	956	22.4 21.0–24.0ROR 22.6 · calibrated p 0.001 ✓	19.2 EB05 18.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	♀ 80% (drug 58%)	not reported in cached trials
Injection site indentation	300	22.3 19.7–25.2ROR 22.4 · calibrated p 0.001 ✓	19.1 EB05 17.4 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=20 · 82% consumer	not reported in cached trials
Product preparation error	2,840	20.6 19.8–21.4ROR 20.9 · calibrated p 0.002 ✓	17.8 EB05 17.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 38.8 · serious n=152 · 87% consumer	not reported in cached trials
Device use error	4,250	18.4 17.8–19.0ROR 18.9 · calibrated p 0.003 ✓	16.2 EB05 15.8 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 30.5 · serious n=305 · 72% consumer	not reported in cached trials
Incorrect dose administered by device	3,021	17.5 16.8–18.1ROR 17.8 · calibrated p 0.003 ✓	15.5 EB05 15.0 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 31.3 · serious n=175	not reported in cached trials
Lack of injection site rotation	194	16.4 14.1–19.0ROR 16.4 · calibrated p 0.005 ✓	14.6 EB05 13.0 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=18 · 75% consumer	not reported in cached trials
Wrong technique in product usage process	22,365	16.1 15.9–16.3ROR 18.5 · calibrated p 0.003 ✓	14.4 EB05 14.2 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 21.9 · serious PRR 16.2	not reported in cached trials
Incorrect dose administered by product	166	15.8 13.5–18.6ROR 15.9 · calibrated p 0.006 ✓	14.2 EB05 12.4 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious n=15 · 74% consumer	not reported in cached trials
Vascular stent stenosis	44	15.3 11.2–20.9ROR 15.3 · calibrated p 0.008 ✓	13.5 EB05 10.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=44 · 100% clinician	NCT01764633: 2/13,769 (0.0%) on Evolocumab; 3/13,756 (0.0%) control (serious AE)
Rubber sensitivity	156	14.7 12.4–17.3ROR 14.7 · calibrated p 0.008 ✓	13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious n=20 · ♀ 82% (drug 58%)	not reported in cached trials
High density lipoprotein abnormal	23	14.0 9.1–21.6ROR 14.0 · calibrated p 0.013 ✓	12.1 EB05 8.1 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	–	not reported in cached trials
Device dispensing error	115	13.9 11.5–16.9ROR 13.9 · calibrated p 0.010 ✓	12.6 EB05 10.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	not reported in cached trials
Application site mass	27	13.9 9.4–20.7ROR 13.9 · calibrated p 0.012 ✓	12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	♀ 0% (drug 58%) · 100% clinician	not reported in cached trials
Obstructive sleep apnoea syndrome	129	13.2 11.0–15.8ROR 13.2 · calibrated p 0.012 ✓	11.9 EB05 10.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=125 · ♀ 12% (drug 58%)	NCT03872401: 3/6,125 (0.0%) on Evolocumab; 1/6,122 (0.0%) control (serious AE)
Fear of injection	626	12.7 11.7–13.8ROR 12.8 · calibrated p 0.013 ✓	11.6 EB05 10.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=42	not reported in cached trials
Circumstance or information capable of leading to medication error	2,878	12.1 11.7–12.6ROR 12.3 · calibrated p 0.015 ✓	11.2 EB05 10.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	age-adj. PRR 6.9 · serious n=55	not reported in cached trials
Myoglobin blood increased	123	11.3 9.4–13.5ROR 11.3 · calibrated p 0.022 ✓	10.3 EB05 8.8 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious n=123 · ♀ 0% (drug 58%)	not reported in cached trials
Product storage error	6,676	10.8 10.5–11.1ROR 11.2 · calibrated p 0.021 ✓	10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 9.9 · serious PRR 14.2	not reported in cached trials
Injury associated with device	1,469	10.2 9.7–10.7ROR 10.3 · calibrated p 0.030 ✓	9.5 EB05 9.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 13.0 · serious n=74	not reported in cached trials
High density lipoprotein increased	66	9.3 7.2–11.9ROR 9.3 · calibrated p 0.045 ✓	8.4 EB05 6.8 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious n=14	not reported in cached trials
Blood triglycerides decreased	22	9.0 5.8–13.8ROR 9.0 · calibrated p 0.057	7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	–	not reported in cached trials
Percutaneous coronary intervention	18	8.7 5.4–14.1ROR 8.7 · calibrated p 0.064	7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=18	NCT01764633: 3/13,769 (0.0%) on Evolocumab; 1/13,756 (0.0%) control (serious AE)
Injection site bruising	4,800	8.4 8.1–8.6ROR 8.6 · calibrated p 0.053	7.9 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 9.0 · serious PRR 15.5	not reported in cached trials
Rhinorrhoea (runny nose)	3,634	7.7 7.5–8.0ROR 7.9 · calibrated p 0.070	7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 6.8 · serious PRR 8.8	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
Hyperglycaemia / diabetes	2,584	1.00.9–1.0	no difference
Rhabdomyolysis / myopathy	536	0.90.8–0.9	lower than other drugs
Myocardial infarction	1,328	0.80.8–0.9	lower than other drugs
Tendon disorder	208	0.70.6–0.8	lower than other drugs
Stroke	1,066	0.60.5–0.6	lower than other drugs
Pancreatitis	256	0.40.4–0.5	lower than other drugs
Arrhythmia / qt	614	0.40.4–0.4	lower than other drugs
Fall / fracture	1,072	0.40.3–0.4	lower than other drugs
Hypoglycaemia	245	0.30.3–0.4	lower than other drugs
Opportunistic infection	341	0.30.3–0.4	lower than other drugs
Serious infection	1,766	0.30.3–0.3	lower than other drugs
Depression	595	0.30.3–0.3	lower than other drugs
Heart failure	364	0.30.2–0.3	lower than other drugs
Anaphylaxis / angioedema	254	0.30.2–0.3	lower than other drugs
Liver injury	609	0.30.2–0.3	lower than other drugs
Malignancy	576	0.20.2–0.2	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Evolocumab 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 (3 of 40 signal terms matched).

NCT01764633 — Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (N=27564, PHASE3; 1722 AE terms posted; arms: Placebo; Evolocumab)
NCT03872401 — Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (N=12301, PHASE3; 1244 AE terms posted; arms: Placebo Q2W; Evolocumab 140 mg Q2W)

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
Device difficult to use	32,925	129.9 128.0–131.8ROR 162.9 · calibrated p 2e-9 ✓	64.8 EB05 64.2 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 154.8 · serious PRR 112.9 · 80% consumer	not reported in cached trials
Drug dose omission by device	24,638	61.6 60.7–62.5ROR 72.5 · calibrated p 1e-6 ✓	41.8 EB05 41.4 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	age-adj. PRR 118.8 · serious n=1,351 · 84% consumer	not reported in cached trials
Wrong technique in product usage process	22,365	16.1 15.9–16.3ROR 18.5 · calibrated p 0.003 ✓	14.4 EB05 14.2 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 21.9 · serious PRR 16.2	not reported in cached trials
Accidental exposure to product	16,804	26.2 25.8–26.6ROR 29.1 · calibrated p 3e-4 ✓	21.9 EB05 21.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 29.0 · serious PRR 30.2	not reported in cached trials
Injection site pain (pain where injected)	10,927	4.8 4.7–4.9ROR 5.1 · calibrated p 0.224	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 5.8 · serious PRR 8.9	NCT01764633: 12/13,769 (0.1%) on Evolocumab; 19/13,756 (0.1%) control (serious AE)
Product storage error	6,676	10.8 10.5–11.1ROR 11.2 · calibrated p 0.021 ✓	10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 9.9 · serious PRR 14.2	not reported in cached trials
Back pain	5,587	3.2 3.1–3.3ROR 3.3 · calibrated p 0.548	3.1 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 3.9	NCT01764633: 30/13,769 (0.2%) on Evolocumab; 30/13,756 (0.2%) control (serious AE)
Myalgia (muscle pain)	5,419	4.3 4.1–4.4ROR 4.4 · calibrated p 0.316	4.1 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.4 · serious PRR 5.8	NCT01764633: 1/13,756 (0.0%) control (serious AE)
Drug dose omission	4,929	3.9 3.8–4.0ROR 4.0 · calibrated p 0.377	3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.4 · serious PRR 2.6	not reported in cached trials
Injection site bruising	4,800	8.4 8.1–8.6ROR 8.6 · calibrated p 0.053	7.9 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 9.0 · serious PRR 15.5	not reported in cached trials
Device use error	4,250	18.4 17.8–19.0ROR 18.9 · calibrated p 0.003 ✓	16.2 EB05 15.8 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 30.5 · serious n=305 · 72% consumer	not reported in cached trials
Arthralgia (joint pain)	4,061	1.3 1.2–1.3ROR 1.3 · calibrated p 0.497	1.3 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 2.2	NCT01764633: 16/13,769 (0.1%) on Evolocumab; 18/13,756 (0.1%) control (serious AE)
Fatigue (tiredness)	4,059	0.7 0.7–0.7ROR 0.7 · calibrated p 0.115	0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.6 · serious PRR 1.3	NCT01764633: 2/13,769 (0.0%) on Evolocumab; 4/13,756 (0.0%) control (serious AE)
Injection site haemorrhage	4,029	6.9 6.7–7.1ROR 7.1 · calibrated p 0.096	6.6 EB05 6.4 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 8.1 · serious PRR 13.8	NCT01764633: 2/13,769 (0.0%) on Evolocumab; 1/13,756 (0.0%) control (serious AE)
Off label use (used outside approved label)	3,936	0.6 0.6–0.6ROR 0.6 · calibrated p 0.076	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.5 · serious PRR 0.6	not reported in cached trials

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.

Fractional exhaled nitric oxide increased — n=119, PRR 291.4
Intercepted product administration error — n=2,520, PRR 62.9
Drug dose omission by device — n=24,638, PRR 61.6
Type iia hyperlipidaemia — n=69, PRR 56.7
Lack of administration site rotation — n=52, PRR 27.3
Occupational exposure to product — n=956, PRR 22.4
Lack of injection site rotation — n=194, PRR 16.4
Vascular stent stenosis — n=44, PRR 15.3 (also seen in trial arm)
Application site mass — n=27, PRR 13.9
Obstructive sleep apnoea syndrome — n=129, PRR 13.2 (also seen in trial arm)

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 Evolocumab?

In FDA FAERS, the most frequently co-reported reaction terms for Evolocumab are drug dose omission by device, injection site pain, back pain, myalgia, injection site bruising, arthralgia. 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 Evolocumab have an FDA boxed warning?

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

Do FAERS signals prove that Evolocumab 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 cd61e902-166d-4aa6-9f3c-a18c1008d07e, effective 20260819; matched on openfda.generic_name.exact:"EVOLOCUMAB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
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, 1,176 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 EVOLOCUMAB, 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.