Hydroxychloroquine Sulfate side effects: what 90,536 FDA adverse event reports show
Drug class
Antimalarial and antirheumatic
Who reports
90,536 reports · 75% serious · 6,265 with death outcome · 86% female
Used for
Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. ( 1.1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients.
What it is
Hydroxychloroquine is an aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus...
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). 1,222 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 |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 67 | 802.1 481.9–1,334.9ROR 802.7 · calibrated p 1e-14 ✓ | 169.5 EB05 138.1 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious n=67 · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 4,768 | 482.7 459.2–507.3ROR 509.4 · calibrated p 5e-14 ✓ | 155.2 EB05 151.5 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious PRR 118.8 · 93% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 181 | 424.4 331.7–543.1ROR 425.3 · calibrated p 6e-13 ✓ | 146.5 EB05 129.4 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=181 · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 3,584 | 386.2 366.1–407.3ROR 402.0 · calibrated p 5e-13 ✓ | 143.7 EB05 139.8 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=3,580 · 91% clinician | not reported in cached trials |
| Rheumatoid factor negative | 109 | 375.7 276.7–509.9ROR 376.1 · calibrated p 3e-12 ✓ | 138.9 EB05 118.3 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=109 · ♀ 0% (drug 86%) · 100% clinician | not reported in cached trials |
| Pemphigus | 7,446 | 351.1 338.8–363.8ROR 382.4 · calibrated p 9e-13 ✓ | 138.6 EB05 136.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 106.1 | not reported in cached trials |
| Swollen joint count increased | 1,793 | 317.1 295.3–340.6ROR 323.5 · calibrated p 5e-12 ✓ | 132.9 EB05 127.8 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=1,792 · 94% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 376 | 302.2 259.0–352.6ROR 303.5 · calibrated p 1e-11 ✓ | 129.5 EB05 118.9 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=375 · 93% clinician | not reported in cached trials |
| Rheumatic fever | 2,381 | 280.5 264.2–297.7ROR 288.0 · calibrated p 1e-11 ✓ | 126.0 EB05 121.8 · IC025 +6.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=2,379 · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 3,870 | 260.7 249.1–272.9ROR 272.3 · calibrated p 2e-11 ✓ | 121.9 EB05 118.8 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 93.0 · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 626 | 259.4 231.3–290.8ROR 261.2 · calibrated p 4e-11 ✓ | 121.3 EB05 113.5 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=626 · 94% clinician | not reported in cached trials |
| Human antichimeric antibody positive | 177 | 254.8 205.6–315.7ROR 255.3 · calibrated p 7e-11 ✓ | 119.2 EB05 105.2 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=177 | not reported in cached trials |
| C-reactive protein | 473 | 254.3 223.1–289.9ROR 255.7 · calibrated p 5e-11 ✓ | 120.0 EB05 111.2 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=473 · 95% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,022 | 254.3 232.7–278.0ROR 257.2 · calibrated p 4e-11 ✓ | 120.3 EB05 114.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=1,022 · 93% clinician | not reported in cached trials |
| Hepatic enzyme | 72 | 248.1 177.7–346.5ROR 248.3 · calibrated p 2e-10 ✓ | 115.6 EB05 94.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=72 · 100% clinician | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 1,197 | 247.5 228.1–268.6ROR 250.8 · calibrated p 5e-11 ✓ | 118.8 EB05 113.3 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=1,196 | not reported in cached trials |
| Hand deformity | 6,673 | 243.2 235.1–251.6ROR 262.5 · calibrated p 3e-11 ✓ | 118.0 EB05 115.7 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 97.7 | not reported in cached trials |
| Musculoskeletal deformity | 120 | 241.5 186.8–312.3ROR 241.9 · calibrated p 1e-10 ✓ | 115.5 EB05 99.2 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=120 · 100% clinician | not reported in cached trials |
| Swollen joint count | 119 | 218.3 169.8–280.7ROR 218.6 · calibrated p 3e-10 ✓ | 109.9 EB05 94.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=119 · 100% clinician | not reported in cached trials |
| Grip strength | 111 | 214.0 165.1–277.2ROR 214.2 · calibrated p 4e-10 ✓ | 108.7 EB05 92.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=111 · 100% clinician | not reported in cached trials |
| Synovitis | 8,328 | 199.7 194.1–205.5ROR 219.9 · calibrated p 2e-10 ✓ | 106.8 EB05 104.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 85.0 | not reported in cached trials |
| C-reactive protein abnormal | 2,946 | 198.4 188.9–208.3ROR 205.0 · calibrated p 3e-10 ✓ | 106.4 EB05 103.2 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=2,945 | not reported in cached trials |
| Granuloma skin | 364 | 182.4 158.9–209.3ROR 183.1 · calibrated p 1e-9 ✓ | 101.1 EB05 92.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=364 | not reported in cached trials |
| X-ray abnormal | 722 | 157.9 143.6–173.6ROR 159.2 · calibrated p 3e-9 ✓ | 93.4 EB05 87.8 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=722 · 92% clinician | not reported in cached trials |
| Facet joint syndrome | 1,242 | 151.1 140.7–162.3ROR 153.2 · calibrated p 4e-9 ✓ | 91.1 EB05 86.9 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=1,242 · 95% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 787 | 148.8 136.0–162.8ROR 150.1 · calibrated p 5e-9 ✓ | 90.2 EB05 85.0 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=787 · 96% clinician | not reported in cached trials |
| Helicobacter infection | 3,923 | 145.4 139.7–151.2ROR 151.9 · calibrated p 4e-9 ✓ | 89.0 EB05 86.7 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 71.7 · 93% clinician | not reported in cached trials |
| Dislocation of vertebra | 854 | 144.7 132.9–157.7ROR 146.1 · calibrated p 6e-9 ✓ | 88.7 EB05 83.8 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=854 · 94% clinician | not reported in cached trials |
| Anticipatory anxiety | 102 | 140.6 109.9–180.0ROR 140.8 · calibrated p 1e-8 ✓ | 85.9 EB05 72.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=102 | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,401 | 138.1 131.3–145.2ROR 141.9 · calibrated p 7e-9 ✓ | 86.3 EB05 83.4 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious n=2,398 · 94% clinician | not reported in cached trials |
| Muscle injury | 3,019 | 135.1 129.2–141.3ROR 139.7 · calibrated p 8e-9 ✓ | 85.1 EB05 82.6 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 70.3 · 94% clinician | not reported in cached trials |
| Folliculitis | 3,344 | 111.0 106.6–115.7ROR 115.2 · calibrated p 4e-8 ✓ | 74.9 EB05 72.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 67.1 · 94% clinician | not reported in cached trials |
| Joint laxity | 98 | 110.9 87.1–141.2ROR 111.0 · calibrated p 8e-8 ✓ | 73.8 EB05 62.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=97 · 100% clinician | not reported in cached trials |
| Retinitis | 537 | 109.9 99.2–121.8ROR 110.6 · calibrated p 6e-8 ✓ | 74.3 EB05 69.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=537 · 93% clinician | not reported in cached trials |
| Contraindicated product administered | 9,646 | 109.0 106.5–111.6ROR 121.9 · calibrated p 2e-8 ✓ | 74.0 EB05 72.8 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 90.2 · serious PRR 70.2 | not reported in cached trials |
| Bone erosion | 1,129 | 108.4 101.1–116.4ROR 109.8 · calibrated p 6e-8 ✓ | 73.7 EB05 70.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=1,126 | not reported in cached trials |
| Presbyacusis | 98 | 106.7 83.9–135.6ROR 106.8 · calibrated p 1e-7 ✓ | 71.9 EB05 60.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=98 · 100% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 170 | 105.1 87.6–126.0ROR 105.3 · calibrated p 1e-7 ✓ | 71.6 EB05 63.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=170 · 100% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 6,867 | 102.8 100.0–105.7ROR 111.1 · calibrated p 5e-8 ✓ | 71.1 EB05 69.7 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 78.3 · 91% clinician | not reported in cached trials |
| Pericarditis | 5,077 | 101.6 98.3–104.9ROR 107.5 · calibrated p 6e-8 ✓ | 70.5 EB05 68.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 54.2 · 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 |
|---|---|---|---|
| Interstitial lung disease | 3,189 | 7.97.7–8.2 | signal |
| Liver injury | 9,997 | 7.97.8–8.1 | signal |
| Opportunistic infection | 2,206 | 3.83.6–4.0 | signal |
| Serious infection | 12,161 | 3.73.6–3.8 | signal |
| Tendon disorder | 561 | 3.43.2–3.7 | signal |
| Hyperglycaemia / diabetes | 4,001 | 2.72.6–2.8 | signal |
| Depression | 2,641 | 2.22.1–2.3 | signal |
| Fall / fracture | 3,378 | 2.12.0–2.1 | raised |
| Anaphylaxis / angioedema | 1,079 | 2.01.9–2.1 | raised |
| Pancreatitis | 551 | 1.61.5–1.7 | raised |
| Rhabdomyolysis / myopathy | 498 | 1.41.3–1.6 | raised |
| Venous thromboembolism | 1,292 | 1.41.3–1.5 | raised |
| Anaemia | 1,779 | 1.41.3–1.4 | raised |
| Malignancy | 2,197 | 1.41.3–1.4 | raised |
| Arrhythmia / qt | 1,078 | 1.31.2–1.4 | raised |
| Severe cutaneous reaction | 379 | 1.21.1–1.3 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Hydroxychloroquine 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).
- NCT04334148 — Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (N=1360, PHASE3; 7 AE terms posted; arms: Hydroxychloroquine; Placebo)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 29,239 | 5.2 5.2–5.3ROR 7.3 · calibrated p 0.089 | 5.1 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.8 · serious PRR 10.0 | not reported in cached trials |
| Rheumatoid arthritis | 20,476 | 51.1 50.4–51.8ROR 65.8 · calibrated p 2e-6 ✓ | 41.9 EB05 41.4 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications | age-adj. PRR 40.7 · serious PRR 37.9 | not reported in cached trials |
| Pain | 16,708 | 6.4 6.3–6.5ROR 7.7 · calibrated p 0.076 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.9 · serious PRR 7.0 | not reported in cached trials |
| Fatigue (tiredness) | 14,220 | 4.3 4.2–4.4ROR 4.9 · calibrated p 0.244 | 4.2 EB05 4.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.7 · serious PRR 5.6 | not reported in cached trials |
| Arthralgia (joint pain) | 13,932 | 8.0 7.9–8.1ROR 9.3 · calibrated p 0.041 ✓ | 7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | age-adj. PRR 7.1 · serious PRR 9.9 | not reported in cached trials |
| Drug intolerance | 12,434 | 34.3 33.7–34.9ROR 39.6 · calibrated p 6e-5 ✓ | 29.9 EB05 29.5 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 36.8 · serious PRR 36.5 | not reported in cached trials |
| Joint swelling | 12,340 | 26.3 25.9–26.8ROR 30.3 · calibrated p 2e-4 ✓ | 23.7 EB05 23.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 22.2 · serious PRR 30.1 | not reported in cached trials |
| Off label use (used outside approved label) | 11,371 | 3.1 3.0–3.1ROR 3.4 · calibrated p 0.521 | 3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 3.0 · serious PRR 4.1 | not reported in cached trials |
| Rash | 10,771 | 5.9 5.8–6.0ROR 6.5 · calibrated p 0.120 | 5.7 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.4 · serious PRR 9.1 | not reported in cached trials |
| Abdominal discomfort | 9,746 | 14.3 14.0–14.6ROR 15.9 · calibrated p 0.005 ✓ | 13.5 EB05 13.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 11.5 · serious PRR 22.3 | not reported in cached trials |
| Contraindicated product administered | 9,646 | 109.0 106.5–111.6ROR 121.9 · calibrated p 2e-8 ✓ | 74.0 EB05 72.8 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 90.2 · serious PRR 70.2 | not reported in cached trials |
| Alopecia (hair loss) | 9,602 | 11.8 11.6–12.1ROR 13.1 · calibrated p 0.012 ✓ | 11.3 EB05 11.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 8.8 · serious PRR 17.6 | not reported in cached trials |
| Nausea | 9,480 | 2.8 2.8–2.9ROR 3.0 · calibrated p 0.621 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 3.6 | not reported in cached trials |
| Systemic lupus erythematosus | 8,928 | 78.2 76.4–80.0ROR 86.6 · calibrated p 3e-7 ✓ | 58.4 EB05 57.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications | age-adj. PRR 61.1 · serious PRR 45.5 | not reported in cached trials |
| Arthropathy | 8,892 | 43.8 42.9–44.8ROR 48.5 · calibrated p 2e-5 ✓ | 36.9 EB05 36.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 38.8 · serious PRR 34.0 | 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.
- Pemphigus — n=7,446, PRR 351.1
- Duodenal ulcer perforation — n=3,870, PRR 260.7
- Lupus vulgaris — n=626, PRR 259.4
- Deep vein thrombosis postoperative — n=1,022, PRR 254.3
- Hepatic enzyme — n=72, PRR 248.1
- Hand deformity — n=6,673, PRR 243.2
- Musculoskeletal deformity — n=120, PRR 241.5
- Swollen joint count — n=119, PRR 218.3
- Grip strength — n=111, PRR 214.0
- Synovitis — n=8,328, PRR 199.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Hydroxychloroquine ↔ Retinopathy.
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 Hydroxychloroquine?
In FDA FAERS, the most frequently co-reported reaction terms for Hydroxychloroquine are rheumatoid arthritis, pain, fatigue, arthralgia, joint swelling, rash. 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 Hydroxychloroquine have an FDA boxed warning?
No. The FDA label retrieved for Hydroxychloroquine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydroxychloroquine 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 7e09aeca-0cec-4a88-9dde-a2098a08b877, effective 20251210; matched on
openfda.generic_name.exact:"HYDROXYCHLOROQUINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3652 description (ChEBI)
- 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, 1,262 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
HYDROXYCHLOROQUINE, 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.