Hydroxychloroquine side effects: what 74,205 FDA adverse event reports show

Hydroxychloroquine · 1,265 reaction terms · 691,676 drug–reaction co-reports · data 2026-09-14

Drug class

Antimalarial and antirheumatic

FDA label, Indications wording

Who reports

74,205 reports · 85% serious · 8,255 with death outcome · 79% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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...

PubChem CID 3652 (ChEBI)

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) 4Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 10Not in label — unassessed 22

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). 1,225 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
Anti-cyclic citrullinated peptide antibody	439	554.3 471.6–651.7ROR 557.6 · calibrated p 3e-14 ✓	184.2 EB05 170.2 · IC025 +7.1 3/3 methods agree	Lab value / disease marker	serious n=439 · ♀ 100% (drug 79%) · 95% clinician	not reported in cached trials
Rheumatoid factor negative	103	397.4 294.1–537.0ROR 398.0 · calibrated p 2e-12 ✓	159.3 EB05 135.1 · IC025 +6.2 3/3 methods agree	Reporting / coding artifact	serious n=103 · ♀ 41% (drug 79%) · 100% clinician	not reported in cached trials
Deep vein thrombosis postoperative	1,025	312.6 286.0–341.6ROR 316.9 · calibrated p 6e-12 ✓	147.2 EB05 139.8 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=1,025 · ♀ 100% (drug 79%) · 94% clinician	not reported in cached trials
Human antichimeric antibody positive	177	311.2 251.2–385.6ROR 312.0 · calibrated p 1e-11 ✓	145.0 EB05 128.0 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious n=177 · ♀ 100% (drug 79%)	not reported in cached trials
Swollen joint count increased	1,580	292.8 272.9–314.1ROR 299.2 · calibrated p 1e-11 ✓	142.8 EB05 137.0 · IC025 +7.0 3/3 methods agree	Lab value / disease marker	serious n=1,580 · ♀ 100% (drug 79%) · 96% clinician	not reported in cached trials
Rheumatic fever	2,186	285.6 269.2–303.1ROR 294.3 · calibrated p 1e-11 ✓	141.2 EB05 136.3 · IC025 +7.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=2,186 · ♀ 100% (drug 79%) · 95% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	3,547	284.1 271.3–297.6ROR 298.3 · calibrated p 1e-11 ✓	140.9 EB05 137.0 · IC025 +7.1 3/3 methods agree	Lab value / disease marker	serious PRR 96.2 · 93% clinician	not reported in cached trials
Lupus vulgaris	588	278.3 248.3–311.9ROR 280.5 · calibrated p 2e-11 ✓	138.9 EB05 129.7 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=588 · ♀ 100% (drug 79%) · 96% clinician	not reported in cached trials
Rheumatoid factor positive	2,700	250.4 237.9–263.7ROR 259.9 · calibrated p 4e-11 ✓	132.1 EB05 127.9 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious n=2,698 · 93% clinician	not reported in cached trials
C-reactive protein	409	233.3 204.6–266.0ROR 234.6 · calibrated p 1e-10 ✓	126.5 EB05 116.6 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=409 · ♀ 100% (drug 79%) · 95% clinician	not reported in cached trials
Grip strength	104	231.1 178.2–299.8ROR 231.5 · calibrated p 2e-10 ✓	123.8 EB05 105.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=104 · ♀ 100% (drug 79%) · 100% clinician	not reported in cached trials
Duodenal ulcer perforation	3,280	229.8 219.5–240.5ROR 240.3 · calibrated p 8e-11 ✓	126.1 EB05 122.5 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 85.8 · ♀ 100% (drug 79%) · 93% clinician	not reported in cached trials
Facet joint syndrome	1,391	224.5 209.3–240.9ROR 228.8 · calibrated p 1e-10 ✓	124.4 EB05 119.0 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=1,391 · ♀ 100% (drug 79%) · 94% clinician	not reported in cached trials
C-reactive protein abnormal	2,765	215.8 205.5–226.7ROR 224.1 · calibrated p 1e-10 ✓	121.8 EB05 118.0 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious n=2,765	not reported in cached trials
Red blood cell sedimentation rate abnormal	994	211.9 195.2–230.1ROR 214.8 · calibrated p 2e-10 ✓	120.4 EB05 114.2 · IC025 +6.7 3/3 methods agree	Lab value / disease marker	serious n=992	not reported in cached trials
Renal phospholipidosis	51	208.4 144.9–299.5ROR 208.5 · calibrated p 9e-10 ✓	114.5 EB05 90.4 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious n=51 · ♀ 100% (drug 79%) · 100% clinician	not reported in cached trials
Swollen joint count	101	197.6 153.1–255.0ROR 197.9 · calibrated p 8e-10 ✓	113.4 EB05 96.1 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=101 · ♀ 100% (drug 79%) · 100% clinician	not reported in cached trials
X-ray abnormal	710	187.5 170.5–206.2ROR 189.3 · calibrated p 7e-10 ✓	112.0 EB05 105.3 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=710 · 95% clinician	not reported in cached trials
Pemphigus	4,795	178.2 172.0–184.7ROR 190.4 · calibrated p 6e-10 ✓	108.9 EB05 106.3 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 74.3 · ♀ 100% (drug 79%)	not reported in cached trials
Adjustment disorder with depressed mood	777	178.0 162.7–194.7ROR 179.8 · calibrated p 1e-9 ✓	108.6 EB05 102.3 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=777 · ♀ 100% (drug 79%) · 96% clinician	not reported in cached trials
Synovitis	6,821	172.4 167.4–177.5ROR 189.8 · calibrated p 6e-10 ✓	106.7 EB05 104.6 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 75.9	not reported in cached trials
Central nervous system lupus	80	165.9 125.7–218.8ROR 166.0 · calibrated p 4e-9 ✓	101.8 EB05 84.4 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious n=80 · ♀ 100% (drug 79%)	not reported in cached trials
Dislocation of vertebra	778	152.4 139.7–166.3ROR 154.0 · calibrated p 4e-9 ✓	98.5 EB05 92.9 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=778 · ♀ 100% (drug 79%) · 94% clinician	not reported in cached trials
Hand deformity	4,529	150.1 144.8–155.5ROR 159.8 · calibrated p 3e-9 ✓	97.7 EB05 95.4 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious PRR 72.2	not reported in cached trials
Granuloma skin	281	145.4 125.9–167.9ROR 145.9 · calibrated p 7e-9 ✓	95.2 EB05 86.2 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=281	not reported in cached trials
Joint laxity	102	143.8 113.3–182.7ROR 144.0 · calibrated p 1e-8 ✓	93.5 EB05 79.2 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=102 · ♀ 100% (drug 79%)	not reported in cached trials
Muscle injury	2,740	142.0 135.7–148.6ROR 147.4 · calibrated p 5e-9 ✓	94.2 EB05 91.3 · IC025 +6.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 69.5 · ♀ 100% (drug 79%) · 94% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	180	139.7 116.8–167.0ROR 140.0 · calibrated p 1e-8 ✓	92.4 EB05 81.6 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=180 · ♀ 100% (drug 79%) · 100% clinician	not reported in cached trials
Helicobacter infection	3,302	135.7 130.2–141.4ROR 142.0 · calibrated p 7e-9 ✓	91.4 EB05 88.9 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 65.8 · ♀ 100% (drug 79%) · 93% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	2,081	135.3 128.4–142.5ROR 139.1 · calibrated p 9e-9 ✓	91.2 EB05 88.0 · IC025 +6.4 3/3 methods agree	Labeled (related wording) related wording	serious n=2,078 · 94% clinician	not reported in cached trials
Truncus arteriosus persistent	65	134.8 100.2–181.2ROR 134.9 · calibrated p 2e-8 ✓	88.8 EB05 72.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=65 · 100% clinician	not reported in cached trials
Anticipatory anxiety	86	132.0 102.1–170.6ROR 132.1 · calibrated p 2e-8 ✓	88.1 EB05 73.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=86 · ♀ 100% (drug 79%)	not reported in cached trials
Retinitis	530	131.7 118.8–146.0ROR 132.6 · calibrated p 1e-8 ✓	89.4 EB05 83.2 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=530 · ♀ 100% (drug 79%) · 93% clinician	not reported in cached trials
Folliculitis	3,042	118.1 113.3–123.2ROR 123.2 · calibrated p 2e-8 ✓	83.1 EB05 80.7 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 66.5 · ♀ 100% (drug 79%) · 94% clinician	not reported in cached trials
Seronegative arthritis	324	114.8 100.9–130.6ROR 115.3 · calibrated p 4e-8 ✓	81.2 EB05 74.0 · IC025 +6.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=324	not reported in cached trials
Body height below normal	187	114.2 96.3–135.3ROR 114.5 · calibrated p 5e-8 ✓	80.6 EB05 71.3 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious n=187 · ♀ 100% (drug 79%)	not reported in cached trials
Red blood cell sedimentation rate	76	104.5 80.3–136.1ROR 104.6 · calibrated p 1e-7 ✓	74.8 EB05 61.8 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious n=76 · 100% clinician	not reported in cached trials
Bone erosion	929	100.5 93.3–108.3ROR 101.8 · calibrated p 1e-7 ✓	74.0 EB05 70.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=929	not reported in cached trials
Peripheral venous disease	1,039	99.4 92.7–106.7ROR 100.8 · calibrated p 1e-7 ✓	73.4 EB05 69.7 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=1,035 · ♀ 100% (drug 79%) · 94% clinician	not reported in cached trials
Intestinal sepsis	65	97.6 73.6–129.5ROR 97.7 · calibrated p 2e-7 ✓	71.0 EB05 57.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=65 · ♀ 0% (drug 79%) · 100% 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	2,729	8.27.9–8.6	signal
Liver injury	8,012	7.77.5–7.8	signal
Opportunistic infection	1,879	3.93.8–4.1	signal
Serious infection	9,478	3.53.4–3.6	signal
Tendon disorder	376	2.82.5–3.1	signal
Hyperglycaemia / diabetes	3,327	2.72.6–2.8	signal
Severe cutaneous reaction	628	2.42.2–2.6	signal
Depression	2,250	2.32.2–2.4	signal
Arrhythmia / qt	1,529	2.22.1–2.4	signal
Rhabdomyolysis / myopathy	589	2.11.9–2.2	raised
Anaphylaxis / angioedema	878	2.01.9–2.1	raised
Fall / fracture	2,377	1.81.7–1.8	raised
Kidney injury	2,322	1.41.4–1.5	raised
Anaemia	1,477	1.41.3–1.5	raised
Venous thromboembolism	995	1.31.2–1.4	raised
Pancreatitis	370	1.31.2–1.4	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)	20,778	4.5 4.5–4.6ROR 5.9 · calibrated p 0.158	4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.0 · serious PRR 8.0	not reported in cached trials
Off label use (used outside approved label)	15,551	5.1 5.1–5.2ROR 6.2 · calibrated p 0.136	5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.3 · serious PRR 5.8	not reported in cached trials
Rheumatoid arthritis	13,126	37.0 36.4–37.7ROR 44.8 · calibrated p 3e-5 ✓	32.8 EB05 32.3 · IC025 +5.0 3/3 methods agree	Likely indication confounding term in indications	age-adj. PRR 29.0 · serious PRR 26.9	not reported in cached trials
Pain	10,613	4.9 4.9–5.0ROR 5.6 · calibrated p 0.179	4.9 EB05 4.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.5 · serious PRR 5.0	not reported in cached trials
Arthralgia (joint pain)	9,457	6.6 6.5–6.7ROR 7.4 · calibrated p 0.084	6.4 EB05 6.3 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 5.5 · serious PRR 7.6	not reported in cached trials
Drug intolerance	9,321	30.2 29.6–30.8ROR 34.4 · calibrated p 1e-4 ✓	27.4 EB05 26.9 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 30.6 · serious PRR 30.0	not reported in cached trials
Fatigue (tiredness)	9,077	3.3 3.3–3.4ROR 3.7 · calibrated p 0.448	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 4.0	not reported in cached trials
Joint swelling	8,663	21.8 21.4–22.3ROR 24.6 · calibrated p 7e-4 ✓	20.3 EB05 20.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 17.3 · serious PRR 23.3	not reported in cached trials
Rash	7,569	5.0 4.9–5.1ROR 5.5 · calibrated p 0.190	4.9 EB05 4.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.4 · serious PRR 7.1	not reported in cached trials
Condition aggravated	7,187	6.9 6.7–7.0ROR 7.5 · calibrated p 0.081	6.7 EB05 6.6 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 5.8 · serious PRR 6.7	not reported in cached trials
Synovitis	6,821	172.4 167.4–177.5ROR 189.8 · calibrated p 6e-10 ✓	106.7 EB05 104.6 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 75.9	not reported in cached trials
Nausea	6,764	2.4 2.4–2.5ROR 2.6 · calibrated p 0.780	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.9	not reported in cached trials
Contraindicated product administered	6,559	78.5 76.5–80.6ROR 86.0 · calibrated p 3e-7 ✓	61.4 EB05 60.2 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 68.0 · serious PRR 51.8	not reported in cached trials
Treatment failure	6,166	22.9 22.3–23.5ROR 24.9 · calibrated p 7e-4 ✓	21.2 EB05 20.8 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 31.9 · serious PRR 27.0	not reported in cached trials
Alopecia (hair loss)	6,054	8.9 8.7–9.2ROR 9.6 · calibrated p 0.036 ✓	8.7 EB05 8.5 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.8 · serious PRR 12.2	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.

Deep vein thrombosis postoperative — n=1,025, PRR 312.6
Lupus vulgaris — n=588, PRR 278.3
Grip strength — n=104, PRR 231.1
Duodenal ulcer perforation — n=3,280, PRR 229.8
Facet joint syndrome — n=1,391, PRR 224.5
Swollen joint count — n=101, PRR 197.6
Pemphigus — n=4,795, PRR 178.2
Adjustment disorder with depressed mood — n=777, PRR 178.0
Synovitis — n=6,821, PRR 172.4
Dislocation of vertebra — n=778, PRR 152.4

✓ 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, arthralgia, fatigue, 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, field patient.drug.openfda.generic_name.exact, 1,265 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.