Drug · FAERS side-effect profile with label screen
Alirocumab side effects: what 24,934 FDA adverse event reports show
Drug class
PCSK9 Inhibitor
FDA label (Established Pharmacologic Class)
Brand names
Praluent
openFDA label
Who reports
24,934 reports · 27% serious · 506 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) 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
Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.
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 1Labeled (related wording) 6Likely indication confounding 4Reporting / coding artifact 7Lab value / disease marker 4Not in label — unassessed 18
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 992 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fractional exhaled nitric oxide increased | 124 | 2,186.8 1,563.5–3,058.5ROR 2,197.7 · χ² 73,862 / p <1e-300 | 550.4 EB05 473.7 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=124 · ♀ 0% (drug 59%) | not reported in cached trials |
| Skin pressure mark | 84 | 696.2 521.1–930.3ROR 698.6 · χ² 31,317 / p <1e-300 | 348.7 EB05 290.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=4 · 83% consumer | not reported in cached trials |
| Administration site indentation | 12 | 221.0 116.9–417.8ROR 221.1 · χ² 1,905 / p <1e-300 | 137.1 EB05 83.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Product delivery mechanism issue | 542 | 105.5 96.6–115.3ROR 107.8 · χ² 49,689 / p <1e-300 | 93.4 EB05 87.0 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=36 · 93% consumer | not reported in cached trials |
| Myoglobin blood increased | 127 | 75.9 63.3–91.0ROR 76.3 · χ² 8,531 / p <1e-300 | 68.9 EB05 59.4 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=127 · ♀ 0% (drug 59%) | not reported in cached trials |
| Low density lipoprotein decreased | 115 | 74.2 61.3–89.7ROR 74.5 · χ² 7,554 / p <1e-300 | 67.4 EB05 57.7 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications | serious n=18 · ♀ 29% (drug 59%) | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 110 | 71.9 59.2–87.3ROR 72.2 · χ² 7,012 / p <1e-300 | 65.5 EB05 55.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=110 · ♀ 0% (drug 59%) | not reported in cached trials |
| Application site injury | 14 | 67.9 39.4–117.0ROR 67.9 · χ² 792 / p 2e-174 | 58.1 EB05 36.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Low density lipoprotein abnormal | 34 | 49.2 34.8–69.5ROR 49.2 · χ² 1,470 / p <1e-300 | 45.4 EB05 34.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications | serious n=12 | not reported in cached trials |
| Administration site bruise | 17 | 44.6 27.4–72.6ROR 44.6 · χ² 647 / p 6e-143 | 40.6 EB05 26.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Low density lipoprotein increased | 356 | 40.8 36.7–45.3ROR 41.3 · χ² 13,124 / p <1e-300 | 38.8 EB05 35.5 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious n=86 | not reported in cached trials |
| Blood cholesterol decreased | 82 | 38.7 31.0–48.3ROR 38.8 · χ² 2,842 / p <1e-300 | 36.7 EB05 30.5 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=22 · 77% consumer | not reported in cached trials |
| Injection site indentation | 84 | 36.1 29.0–44.9ROR 36.2 · χ² 2,715 / p <1e-300 | 34.4 EB05 28.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · 88% consumer | not reported in cached trials |
| Brain natriuretic peptide increased | 127 | 36.1 30.2–43.1ROR 36.3 · χ² 4,122 / p <1e-300 | 34.5 EB05 29.7 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=125 · ♀ 0% (drug 59%) | NCT01663402: 1/9,451 (0.0%) on Alirocumab (serious AE) |
| Plantar fasciitis | 132 | 34.3 28.8–40.8ROR 34.5 · χ² 4,066 / p <1e-300 | 32.8 EB05 28.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=125 · ♀ 3% (drug 59%) | not reported in cached trials |
| Morphoea | 16 | 29.2 17.7–48.1ROR 29.2 · χ² 394 / p 5e-88 | 27.4 EB05 17.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Wrong schedule | 31 | 28.4 19.8–40.6ROR 28.4 · χ² 765 / p 1e-168 | 27.1 EB05 20.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | 77% consumer | not reported in cached trials |
| Device operational issue | 137 | 28.2 23.8–33.4ROR 28.3 · χ² 3,445 / p <1e-300 | 27.2 EB05 23.6 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=5 | not reported in cached trials |
| Device use issue | 472 | 23.5 21.5–25.8ROR 24.0 · χ² 9,896 / p <1e-300 | 22.9 EB05 21.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=24 · 82% consumer | not reported in cached trials |
| High density lipoprotein increased | 23 | 20.1 13.3–30.3ROR 20.1 · χ² 388 / p 9e-87 | 19.3 EB05 13.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=8 | not reported in cached trials |
| Product dose omission | 1,364 | 17.7 16.8–18.6ROR 18.6 · χ² 21,051 / p <1e-300 | 17.3 EB05 16.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 · 88% consumer | not reported in cached trials |
| Product preparation error | 416 | 17.2 15.6–19.0ROR 17.5 · χ² 6,217 / p <1e-300 | 16.9 EB05 15.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=32 · 90% consumer | not reported in cached trials |
| Injection site exfoliation | 12 | 15.5 8.8–27.5ROR 15.5 · χ² 146 / p 6e-34 | 14.0 EB05 7.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Injection site hypoaesthesia | 25 | 15.2 10.2–22.5ROR 15.2 · χ² 311 / p 7e-70 | 14.5 EB05 10.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | 72% consumer | NCT01663402: 2/9,451 (0.0%) on Alirocumab; 3/9,443 (0.0%) control (serious AE) |
| Waist circumference increased | 18 | 14.7 9.2–23.5ROR 14.7 · χ² 213 / p 2e-48 | 13.8 EB05 8.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Injury associated with device | 335 | 14.2 12.8–15.8ROR 14.4 · χ² 4,041 / p <1e-300 | 14.0 EB05 12.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Injection site dryness | 14 | 13.5 8.0–22.9ROR 13.5 · χ² 147 / p 3e-34 | 12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Sensation of foreign body | 128 | 13.0 10.9–15.5ROR 13.1 · χ² 1,387 / p <1e-300 | 12.8 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=124 · ♀ 5% (drug 59%) | not reported in cached trials |
| Product administered at inappropriate site | 268 | 12.6 11.2–14.2ROR 12.7 · χ² 2,806 / p <1e-300 | 12.4 EB05 11.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=18 | not reported in cached trials |
| High density lipoprotein decreased | 46 | 11.7 8.8–15.7ROR 11.8 · χ² 435 / p 7e-97 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=15 · ♀ 37% (drug 59%) | not reported in cached trials |
| Exostosis | 112 | 10.4 8.7–12.6ROR 10.5 · χ² 935 / p 1e-205 | 10.2 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.2 · ♀ 0% (drug 59%) | not reported in cached trials |
| Increased upper airway secretion | 63 | 10.3 8.1–13.3ROR 10.4 · χ² 516 / p 1e-114 | 9.9 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 6% (drug 59%) | not reported in cached trials |
| Secretion discharge | 148 | 10.2 8.7–12.0ROR 10.2 · χ² 1,202 / p 9e-264 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 · ♀ 15% (drug 59%) | not reported in cached trials |
| Obstructive airways disorder | 128 | 9.7 8.2–11.6ROR 9.8 · χ² 985 / p 2e-216 | 9.5 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.0 · ♀ 0% (drug 59%) | NCT01663402: 11/9,451 (0.1%) on Alirocumab; 7/9,443 (0.1%) control (serious AE) |
| Injection site bruising | 861 | 9.3 8.7–9.9ROR 9.6 · χ² 6,301 / p <1e-300 | 9.2 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 · 77% consumer | not reported in cached trials |
| Induration | 18 | 8.6 5.4–13.6ROR 8.6 · χ² 112 / p 2e-26 | 7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Myalgia (muscle pain) | 1,683 | 8.4 8.0–8.8ROR 8.9 · χ² 10,944 / p <1e-300 | 8.3 EB05 8.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | NCT01663402: 5/9,451 (0.1%) on Alirocumab; 5/9,443 (0.1%) control (serious AE) |
| Influenza like illness (flu-like illness) | 805 | 8.3 7.7–8.8ROR 8.5 · χ² 5,101 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | NCT01663402: 2/9,451 (0.0%) on Alirocumab (serious AE) |
| Administration site pain | 11 | 8.2 4.5–14.9ROR 8.2 · χ² 62 / p 2e-15 | 6.5 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Aortic valve replacement | 12 | 8.2 4.7–14.5ROR 8.2 · χ² 68 / p 7e-17 | 6.6 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Alirocumab 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 (5 of 40 signal terms matched).
- NCT01663402 — ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With (N=18924, PHASE3; 1532 AE terms posted; arms: Placebo; Alirocumab)
- NCT01507831 — Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying T (N=2341, PHASE3; 344 AE terms posted; arms: Placebo Q2W; Alirocumab 150 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 |
|---|---|---|---|---|---|---|
| Myalgia (muscle pain) | 1,683 | 8.4 8.0–8.8ROR 8.9 · χ² 10,944 / p <1e-300 | 8.3 EB05 8.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | NCT01663402: 5/9,451 (0.1%) on Alirocumab; 5/9,443 (0.1%) control (serious AE) |
| Product dose omission | 1,364 | 17.7 16.8–18.6ROR 18.6 · χ² 21,051 / p <1e-300 | 17.3 EB05 16.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 · 88% consumer | not reported in cached trials |
| Injection site pain (pain where injected) | 1,319 | 3.7 3.5–3.9ROR 3.8 · χ² 2,581 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 · 77% consumer | NCT01663402: 9/9,451 (0.1%) on Alirocumab; 12/9,443 (0.1%) control (serious AE) |
| Muscle spasms | 1,191 | 5.5 5.2–5.8ROR 5.7 · χ² 4,374 / p <1e-300 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 72% consumer | NCT01663402: 1/9,451 (0.0%) on Alirocumab; 3/9,443 (0.0%) control (serious AE) |
| Arthralgia (joint pain) | 1,074 | 2.2 2.1–2.3ROR 2.2 · χ² 699 / p 2e-154 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | NCT01663402: 2/9,451 (0.0%) on Alirocumab; 3/9,443 (0.0%) control (serious AE) |
| Fatigue (tiredness) | 1,033 | 1.1 1.1–1.2ROR 1.1 · χ² 13 / p 1e-4 | 1.1 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.3 · 74% consumer | NCT01663402: 1/9,451 (0.0%) on Alirocumab; 4/9,443 (0.0%) control (serious AE) |
| Pain | 965 | 1.3 1.2–1.4ROR 1.3 · χ² 76 / p 1e-18 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 · 77% consumer | NCT01663402: 9/9,451 (0.1%) on Alirocumab; 12/9,443 (0.1%) control (serious AE) |
| Pain in extremity | 942 | 2.7 2.5–2.9ROR 2.8 · χ² 1,009 / p 1e-221 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 73% consumer | NCT01663402: 5/9,451 (0.1%) on Alirocumab; 6/9,443 (0.1%) control (serious AE) |
| Product dose omission issue | 913 | 2.7 2.5–2.9ROR 2.8 · χ² 987 / p 5e-217 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 79% consumer | not reported in cached trials |
| Injection site bruising | 861 | 9.3 8.7–9.9ROR 9.6 · χ² 6,301 / p <1e-300 | 9.2 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 · 77% consumer | not reported in cached trials |
| Diarrhoea (diarrhea) | 812 | 1.1 1.0–1.1ROR 1.1 · χ² 3 / p 0.043 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | NCT01663402: 4/9,451 (0.0%) on Alirocumab; 7/9,443 (0.1%) control (serious AE) |
| Headache | 811 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.007 | 1.1 EB05 1.0 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.4 · 72% consumer | NCT01663402: 4/9,451 (0.0%) on Alirocumab; 7/9,443 (0.1%) control (serious AE) |
| Influenza like illness (flu-like illness) | 805 | 8.3 7.7–8.8ROR 8.5 · χ² 5,101 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | NCT01663402: 2/9,451 (0.0%) on Alirocumab (serious AE) |
| Device issue | 789 | 7.7 7.2–8.2ROR 7.9 · χ² 4,543 / p <1e-300 | 7.6 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 84% consumer | not reported in cached trials |
| Cough | 725 | 2.2 2.0–2.3ROR 2.2 · χ² 468 / p 4e-104 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 71% consumer | NCT01663402: 1/9,451 (0.0%) on Alirocumab; 1/9,443 (0.0%) control (serious AE) |
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=124, PRR 2,186.8
- Skin pressure mark — n=84, PRR 696.2
- Obstructive sleep apnoea syndrome — n=110, PRR 71.9
- Plantar fasciitis — n=132, PRR 34.3
- Injury associated with device — n=335, PRR 14.2
- Sensation of foreign body — n=128, PRR 13.0
- Exostosis — n=112, PRR 10.4
- Increased upper airway secretion — n=63, PRR 10.3
- Secretion discharge — n=148, PRR 10.2
- Obstructive airways disorder — n=128, PRR 9.7 (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 Alirocumab?
In FDA FAERS, the most frequently co-reported reaction terms for Alirocumab are myalgia, injection site pain, muscle spasms, arthralgia, fatigue, pain. 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 Alirocumab have an FDA boxed warning?
No. The FDA label retrieved for Alirocumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Alirocumab 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 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4, effective 20260707; matched on
openfda.generic_name.exact:"ALIROCUMAB") - 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, 1,032 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
ALIROCUMAB, 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.