Drug · FAERS side-effect profile with label screen
Voxelotor side effects: what 22,300 FDA adverse event reports show
Drug class
Hemoglobin S Polymerization Inhibitor
FDA label (Established Pharmacologic Class)
Brand names
Oxbryta
openFDA label
Who reports
22,300 reports · 43% serious · 416 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
FDA label, Indications and Usage
What it is
OXBRYTA contains voxelotor, a hemoglobin S polymerization inhibitor.
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) 2Likely indication confounding 4Reporting / coding artifact 10Lab value / disease marker 3Not in label — unassessed 20
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. 668 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 |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 11,218 | 2,377.3 2,301.5–2,455.5ROR 4,782.7 · χ² 7,479,904 / p <1e-300 | 666.8 EB05 656.6 · IC025 +9.3 3/3 methods agree | Not in label — unassessed | serious PRR 770.2 · 88% consumer | NCT04930445: 131/260 (50.4%) on Voxelotor (serious AE) |
| Acute chest syndrome | 391 | 766.2 670.6–875.5ROR 779.9 · χ² 163,175 / p <1e-300 | 411.4 EB05 378.3 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=391 | NCT03036813: 2/92 (2.2%) on Voxelotor; 1/91 (1.1%) control (serious AE) |
| Sickle cell disease | 174 | 576.0 476.9–695.7ROR 580.5 · χ² 61,246 / p <1e-300 | 342.2 EB05 301.6 · IC025 +7.2 3/3 methods agree | Likely indication confounding term in indications | serious n=145 · 94% consumer | not reported in cached trials |
| Hypersplenism | 77 | 174.1 136.5–222.0ROR 174.7 · χ² 11,010 / p <1e-300 | 141.6 EB05 117.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=70 | NCT03036813: 1/88 (1.1%) on Voxelotor (serious AE) |
| Abdominal symptom | 50 | 63.2 47.5–84.2ROR 63.4 · χ² 2,809 / p <1e-300 | 58.0 EB05 45.7 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=43 · ♀ 38% (drug 60%) · 100% clinician | not reported in cached trials |
| Emergency care | 125 | 41.2 34.5–49.3ROR 41.5 · χ² 4,662 / p <1e-300 | 39.3 EB05 33.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=44 · 86% consumer | not reported in cached trials |
| Sickle cell anaemia | 26 | 39.1 26.4–57.8ROR 39.1 · χ² 889 / p 1e-195 | 36.6 EB05 26.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=23 · 81% consumer | NCT04930445: 131/260 (50.4%) on Voxelotor (serious AE) |
| Disease complication | 127 | 26.7 22.4–31.8ROR 26.8 · χ² 3,028 / p <1e-300 | 25.9 EB05 22.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=99 · 94% consumer | not reported in cached trials |
| Priapism | 91 | 25.3 20.6–31.2ROR 25.4 · χ² 2,045 / p <1e-300 | 24.6 EB05 20.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 0% (drug 60%) | NCT04930445: 1/260 (0.4%) on Voxelotor |
| Reticulocyte count increased | 20 | 23.7 15.2–37.0ROR 23.8 · χ² 403 / p 7e-90 | 22.7 EB05 15.5 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Coronavirus infection | 152 | 21.9 18.7–25.7ROR 22.0 · χ² 2,943 / p <1e-300 | 21.4 EB05 18.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=98 · 95% consumer | not reported in cached trials |
| Expulsion of medication | 11 | 21.2 11.7–38.5ROR 21.2 · χ² 188 / p 5e-43 | 19.7 EB05 11.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=1 | not reported in cached trials |
| Therapy cessation | 1,040 | 19.5 18.4–20.7ROR 20.4 · χ² 17,924 / p <1e-300 | 19.1 EB05 18.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 19.3 · 85% consumer | not reported in cached trials |
| Product use complaint | 298 | 18.4 16.4–20.6ROR 18.7 · χ² 4,799 / p <1e-300 | 18.1 EB05 16.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=69 · 94% consumer | not reported in cached trials |
| Haemoglobin increased | 86 | 18.3 14.8–22.6ROR 18.4 · χ² 1,362 / p 2e-298 | 17.9 EB05 14.9 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=31 · 84% consumer | NCT03036813: 1/92 (1.1%) on Voxelotor (serious AE) |
| Product dose omission issue | 5,172 | 17.4 17.0–17.8ROR 22.3 · χ² 79,448 / p <1e-300 | 17.1 EB05 16.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 42.8 · 98% consumer | not reported in cached trials |
| Blood bilirubin decreased | 11 | 17.0 9.3–30.8ROR 17.0 · χ² 147 / p 4e-34 | 15.4 EB05 8.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=2 | NCT04930445: 1/260 (0.4%) on Voxelotor |
| Insurance issue | 201 | 12.9 11.2–14.8ROR 13.0 · χ² 2,163 / p <1e-300 | 12.7 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · 96% consumer | not reported in cached trials |
| Therapy interrupted | 900 | 12.4 11.6–13.2ROR 12.9 · χ² 9,343 / p <1e-300 | 12.3 EB05 11.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 18.9 · 81% consumer | not reported in cached trials |
| Haemoglobin abnormal | 82 | 12.2 9.8–15.2ROR 12.2 · χ² 821 / p 8e-181 | 11.9 EB05 9.8 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=36 · 82% consumer | NCT03036813: 1/92 (1.1%) on Voxelotor (serious AE) |
| Bone marrow transplant | 24 | 12.1 8.1–18.1ROR 12.1 · χ² 230 / p 3e-52 | 11.3 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=24 · 75% consumer | not reported in cached trials |
| Product size issue | 47 | 8.4 6.3–11.2ROR 8.4 · χ² 295 / p 2e-66 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=17 · 98% consumer | not reported in cached trials |
| Faeces soft | 58 | 7.6 5.9–9.8ROR 7.6 · χ² 323 / p 2e-72 | 7.2 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=23 · 91% consumer | not reported in cached trials |
| Central venous catheterisation | 23 | 7.2 4.8–10.9ROR 7.2 · χ² 116 / p 3e-27 | 6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=16 · 96% consumer | not reported in cached trials |
| Haemoglobin decreased | 753 | 6.9 6.5–7.4ROR 7.1 · χ² 3,801 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.0 · 88% consumer | NCT03036813: 1/92 (1.1%) on Voxelotor (serious AE) |
| Blood iron increased | 13 | 6.5 3.8–11.3ROR 6.5 · χ² 55 / p 6e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious n=7 | NCT04930445: 2/260 (0.8%) on Voxelotor (serious AE) |
| Therapy non-responder | 295 | 6.3 5.6–7.0ROR 6.3 · χ² 1,292 / p 3e-283 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 91% consumer | not reported in cached trials |
| Medical procedure | 10 | 5.8 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=7 | not reported in cached trials |
| Abdominal discomfort | 969 | 5.5 5.1–5.8ROR 5.7 · χ² 3,549 / p <1e-300 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 94% consumer | not reported in cached trials |
| Abdominal pain upper | 1,171 | 5.4 5.1–5.7ROR 5.6 · χ² 4,194 / p <1e-300 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 97% consumer | NCT03036813: 13/88 (14.8%) on Voxelotor; 10/91 (11.0%) control |
| Transfusion | 59 | 5.3 4.1–6.8ROR 5.3 · χ² 200 / p 8e-46 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 81% consumer | NCT04930445: 1/260 (0.4%) on Voxelotor (serious AE) |
| Diarrhoea (diarrhea) | 3,187 | 4.7 4.5–4.8ROR 5.3 · χ² 9,455 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 92% consumer | NCT03036813: 1/92 (1.1%) on Voxelotor (serious AE) |
| Nail discolouration | 19 | 4.6 2.9–7.2ROR 4.6 · χ² 49 / p 1e-12 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Skin ulcer | 114 | 4.2 3.5–5.0ROR 4.2 · χ² 270 / p 5e-61 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | NCT04930445: 1/260 (0.4%) on Voxelotor (serious AE) |
| Ocular icterus | 19 | 4.1 2.6–6.5ROR 4.1 · χ² 42 / p 5e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=6 | NCT03036813: 6/88 (6.8%) on Voxelotor; 8/91 (8.8%) control |
| Thrombocytosis | 16 | 4.1 2.5–6.8ROR 4.1 · χ² 35 / p 2e-9 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT03036813: 1/91 (1.1%) control (serious AE) |
| Product administration interrupted | 33 | 4.1 2.9–5.7ROR 4.1 · χ² 73 / p 7e-18 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=17 · 91% consumer | not reported in cached trials |
| Osteonecrosis (bone death) | 124 | 3.5 3.0–4.2ROR 3.5 · χ² 221 / p 2e-50 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | NCT04930445: 8/260 (3.1%) on Voxelotor (serious AE) |
| Product dose omission in error | 98 | 3.4 2.8–4.2ROR 3.5 · χ² 167 / p 2e-38 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 79% consumer | not reported in cached trials |
| Hip surgery | 19 | 3.4 2.1–5.3ROR 3.4 · χ² 29 / p 3e-8 | 3.2 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=19 | 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 Voxelotor 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 (17 of 40 signal terms matched).
- NCT03036813 — Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) (N=449, PHASE3; 107 AE terms posted; arms: Voxelotor 900 mg; Voxelotor 1500 mg; Placebo)
- NCT04930445 — Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals Wit (N=265, phase n/a; 130 AE terms posted; arms: All Participants)
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 |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 11,218 | 2,377.3 2,301.5–2,455.5ROR 4,782.7 · χ² 7,479,904 / p <1e-300 | 666.8 EB05 656.6 · IC025 +9.3 3/3 methods agree | Not in label — unassessed | serious PRR 770.2 · 88% consumer | NCT04930445: 131/260 (50.4%) on Voxelotor (serious AE) |
| Product dose omission issue | 5,172 | 17.4 17.0–17.8ROR 22.3 · χ² 79,448 / p <1e-300 | 17.1 EB05 16.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 42.8 · 98% consumer | not reported in cached trials |
| Diarrhoea (diarrhea) | 3,187 | 4.7 4.5–4.8ROR 5.3 · χ² 9,455 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 92% consumer | NCT03036813: 1/92 (1.1%) on Voxelotor (serious AE) |
| Off label use (used outside approved label) | 2,417 | 2.6 2.5–2.7ROR 2.8 · χ² 2,524 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 92% consumer | not reported in cached trials |
| Nausea | 2,016 | 2.4 2.3–2.5ROR 2.5 · χ² 1,716 / p <1e-300 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 · 92% consumer | NCT03036813: 1/88 (1.1%) on Voxelotor (serious AE) |
| Headache | 1,691 | 2.5 2.4–2.7ROR 2.7 · χ² 1,627 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 · 92% consumer | NCT03036813: 1/88 (1.1%) on Voxelotor (serious AE) |
| Abdominal pain upper | 1,171 | 5.4 5.1–5.7ROR 5.6 · χ² 4,194 / p <1e-300 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 97% consumer | NCT03036813: 13/88 (14.8%) on Voxelotor; 10/91 (11.0%) control |
| Pain | 1,085 | 1.7 1.6–1.8ROR 1.7 · χ² 292 / p 1e-65 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 · 75% consumer | NCT03036813: 2/92 (2.2%) on Voxelotor; 1/91 (1.1%) control (serious AE) |
| Therapy cessation | 1,040 | 19.5 18.4–20.7ROR 20.4 · χ² 17,924 / p <1e-300 | 19.1 EB05 18.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 19.3 · 85% consumer | not reported in cached trials |
| Fatigue (tiredness) | 1,007 | 1.2 1.1–1.3ROR 1.2 · χ² 41 / p 8e-11 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 0.9 · 93% consumer | NCT03036813: 12/88 (13.6%) on Voxelotor; 12/91 (13.2%) control |
| Abdominal discomfort | 969 | 5.5 5.1–5.8ROR 5.7 · χ² 3,549 / p <1e-300 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 94% consumer | not reported in cached trials |
| Therapy interrupted | 900 | 12.4 11.6–13.2ROR 12.9 · χ² 9,343 / p <1e-300 | 12.3 EB05 11.6 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 18.9 · 81% consumer | not reported in cached trials |
| Vomiting | 833 | 1.7 1.6–1.8ROR 1.7 · χ² 229 / p 5e-52 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.0 · 91% consumer | NCT03036813: 11/88 (12.5%) on Voxelotor; 15/91 (16.5%) control |
| Haemoglobin decreased | 753 | 6.9 6.5–7.4ROR 7.1 · χ² 3,801 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.0 · 88% consumer | NCT03036813: 1/92 (1.1%) on Voxelotor (serious AE) |
| Abdominal pain | 627 | 2.5 2.4–2.7ROR 2.6 · χ² 589 / p 2e-130 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.2 · 88% consumer | NCT03036813: 13/88 (14.8%) on Voxelotor; 10/91 (11.0%) control |
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.
- Sickle cell anaemia with crisis — n=11,218, PRR 2,377.3 (also seen in trial arm)
- Acute chest syndrome — n=391, PRR 766.2 (also seen in trial arm)
- Hypersplenism — n=77, PRR 174.1 (also seen in trial arm)
- Emergency care — n=125, PRR 41.2
- Sickle cell anaemia — n=26, PRR 39.1 (also seen in trial arm)
- Priapism — n=91, PRR 25.3 (also seen in trial arm)
- Coronavirus infection — n=152, PRR 21.9
- Insurance issue — n=201, PRR 12.9
- Bone marrow transplant — n=24, PRR 12.1
- Faeces soft — n=58, PRR 7.6
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 Voxelotor?
In FDA FAERS, the most frequently co-reported reaction terms for Voxelotor are sickle cell anaemia with crisis, diarrhoea, nausea, headache, abdominal pain upper, 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 Voxelotor have an FDA boxed warning?
No. The FDA label retrieved for Voxelotor has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Voxelotor 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 3c557fac-29ec-483f-b691-8a935d4decc3, effective 20231226; matched on
openfda.generic_name.exact:"VOXELOTOR") - 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, 708 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
VOXELOTOR, 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.