Ritonavir side effects: what 29,045 FDA adverse event reports show

Ritonavir · 1,202 reaction terms · 102,599 drug–reaction co-reports · data 2026-09-14

Drug class

Cytochrome P450 3A Inhibitor, Protease Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

29,045 reports · 91% serious · 2,637 with death outcome · 37% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Ritonavir tablets are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection ( 1 )

FDA label, Indications and Usage

What it is

Ritonavir is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV). Ritonavir, USP is chemically designated as 2, 4, 7, 12-Tetraazatridecan-13-oic acid,10-h.

FDA label, Description section

Boxed warning

DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid pr.

FDA 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 4Labeled (related wording) 1Lab value / disease marker 3Not in label — unassessed 32

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.
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). 1,162 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
Progressive external ophthalmoplegia	114	5,406.2 3,156.1–9,260.4ROR 5,427.5 · calibrated p 5e-24 ✓	569.0 EB05 486.6 · IC025 +7.1 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=114 · ♀ 0% (drug 37%) · 94% clinician	no trial data cached
Aids encephalopathy	34	1,007.7 597.7–1,699.1ROR 1,008.9 · calibrated p 2e-15 ✓	338.0 EB05 253.0 · IC025 +5.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=34 · ♀ 15% (drug 37%)	no trial data cached
Ultrasound antenatal screen	54	960.3 638.1–1,445.1ROR 962.1 · calibrated p 6e-16 ✓	357.3 EB05 284.2 · IC025 +6.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=54 · 100% clinician	no trial data cached
Cloacal exstrophy	32	843.1 505.2–1,406.8ROR 844.0 · calibrated p 9e-15 ✓	313.8 EB05 232.7 · IC025 +5.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=32 · 100% clinician	no trial data cached
Cd4/cd8 ratio decreased	97	663.5 503.2–874.7ROR 665.7 · calibrated p 8e-15 ✓	321.9 EB05 271.6 · IC025 +6.6 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Lab value / disease marker	serious n=97	no trial data cached
Bladder agenesis	33	572.5 362.1–905.3ROR 573.2 · calibrated p 2e-13 ✓	268.3 EB05 199.9 · IC025 +5.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=33 · 100% clinician	no trial data cached
Hiv associated nephropathy	18	400.1 224.6–712.8ROR 400.4 · calibrated p 2e-11 ✓	201.8 EB05 135.0 · IC025 +4.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=18	no trial data cached
Blood hiv rna	18	388.0 218.5–689.0ROR 388.2 · calibrated p 3e-11 ✓	198.7 EB05 133.0 · IC025 +4.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=16	no trial data cached
Congenital naevus	43	332.5 231.5–477.4ROR 333.0 · calibrated p 2e-11 ✓	206.2 EB05 159.5 · IC025 +5.5 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=43 · ♀ 100% (drug 37%)	no trial data cached
Supernumerary nipple	25	329.3 205.0–529.0ROR 329.6 · calibrated p 4e-11 ✓	192.5 EB05 137.1 · IC025 +4.7 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=25 · ♀ 100% (drug 37%)	no trial data cached
Gastrointestinal disorder congenital	32	311.8 205.8–472.4ROR 312.2 · calibrated p 4e-11 ✓	192.3 EB05 142.6 · IC025 +5.1 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=32 · 100% clinician	no trial data cached
Aids dementia complex	18	297.8 171.8–516.2ROR 298.0 · calibrated p 2e-10 ✓	172.1 EB05 115.2 · IC025 +4.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=18	no trial data cached
Hypercorticoidism	30	280.8 184.0–428.4ROR 281.1 · calibrated p 1e-10 ✓	178.8 EB05 131.3 · IC025 +4.9 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=29	no trial data cached
Csf hiv escape syndrome	39	280.2 193.5–405.8ROR 280.6 · calibrated p 8e-11 ✓	183.4 EB05 140.0 · IC025 +5.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=39 · 100% clinician	no trial data cached
Alpha 1 foetoprotein abnormal	28	276.6 178.8–428.0ROR 276.9 · calibrated p 1e-10 ✓	175.7 EB05 127.6 · IC025 +4.8 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Lab value / disease marker	serious n=22	no trial data cached
Genitalia external ambiguous	41	220.9 155.7–313.6ROR 221.3 · calibrated p 5e-10 ✓	156.6 EB05 120.4 · IC025 +5.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=41 · ♀ 65% (drug 37%) · 90% clinician	no trial data cached
Hemivertebra	40	220.6 154.7–314.4ROR 220.9 · calibrated p 5e-10 ✓	156.2 EB05 119.6 · IC025 +5.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=40	no trial data cached
Lipodystrophy acquired	460	198.8 179.4–220.3ROR 202.0 · calibrated p 4e-10 ✓	154.6 EB05 143.1 · IC025 +6.9 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious n=451	no trial data cached
Meconium stain	33	194.0 132.0–285.0ROR 194.2 · calibrated p 2e-9 ✓	140.4 EB05 104.6 · IC025 +5.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=34 · ♀ 100% (drug 37%) · 100% clinician	no trial data cached
Bone demineralisation	215	183.6 158.1–213.2ROR 185.0 · calibrated p 9e-10 ✓	144.3 EB05 128.8 · IC025 +6.5 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=202	no trial data cached
Caudal regression syndrome	32	183.6 124.5–270.7ROR 183.8 · calibrated p 3e-9 ✓	134.6 EB05 99.8 · IC025 +4.9 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=32 · 100% clinician	no trial data cached
Ergot poisoning	25	177.8 114.7–275.6ROR 178.0 · calibrated p 6e-9 ✓	128.7 EB05 91.7 · IC025 +4.6 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=25 · 100% clinician	no trial data cached
Hiv-associated neurocognitive disorder	22	175.8 110.3–280.4ROR 176.0 · calibrated p 7e-9 ✓	126.0 EB05 87.7 · IC025 +4.4 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=22	no trial data cached
Mitochondrial toxicity	159	173.2 145.7–205.9ROR 174.2 · calibrated p 2e-9 ✓	137.2 EB05 120.2 · IC025 +6.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=159 · ♀ 9% (drug 37%)	no trial data cached
Acoustic stimulation tests abnormal	29	165.0 110.2–247.1ROR 165.2 · calibrated p 8e-9 ✓	123.4 EB05 90.1 · IC025 +4.7 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=29 · ♀ 100% (drug 37%)	no trial data cached
Cushing's syndrome	123	152.7 125.7–185.5ROR 153.3 · calibrated p 5e-9 ✓	123.5 EB05 106.3 · IC025 +6.1 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious n=117	no trial data cached
Congenital genital malformation	27	144.4 95.5–218.4ROR 144.5 · calibrated p 2e-8 ✓	111.0 EB05 80.1 · IC025 +4.6 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=27 · 100% clinician	no trial data cached
Cd4 lymphocytes abnormal	35	143.9 100.1–206.9ROR 144.1 · calibrated p 2e-8 ✓	112.6 EB05 84.7 · IC025 +4.9 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Lab value / disease marker	serious n=35	no trial data cached
Immune reconstitution syndrome	212	139.8 120.7–161.9ROR 140.8 · calibrated p 9e-9 ✓	115.8 EB05 103.3 · IC025 +6.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious n=209	no trial data cached
Ultrasound antenatal screen abnormal	35	134.6 93.8–193.1ROR 134.7 · calibrated p 3e-8 ✓	106.9 EB05 80.3 · IC025 +4.9 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=30 · ♀ 100% (drug 37%) · 100% clinician	no trial data cached
Trisomy 18	58	128.5 97.2–170.0ROR 128.8 · calibrated p 3e-8 ✓	105.3 EB05 84.5 · IC025 +5.4 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=57 · 100% clinician	no trial data cached
Virologic failure	809	127.4 118.3–137.2ROR 131.0 · calibrated p 1e-8 ✓	107.9 EB05 101.8 · IC025 +6.5 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled (related wording) related wording	serious n=797 · 97% clinician	no trial data cached
Ventricular hypoplasia	36	121.9 85.6–173.6ROR 122.1 · calibrated p 6e-8 ✓	98.9 EB05 74.6 · IC025 +4.9 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=36	no trial data cached
Tethered cord syndrome	30	111.7 76.0–164.2ROR 111.8 · calibrated p 1e-7 ✓	91.2 EB05 67.0 · IC025 +4.6 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=30 · 100% clinician	no trial data cached
Anogenital dysplasia	19	104.0 64.3–168.2ROR 104.0 · calibrated p 4e-7 ✓	83.5 EB05 56.5 · IC025 +4.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=19	no trial data cached
Heterotaxia	21	103.0 65.2–162.8ROR 103.1 · calibrated p 4e-7 ✓	83.5 EB05 57.6 · IC025 +4.1 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=21 · ♀ 0% (drug 37%) · 100% clinician	no trial data cached
Congenital anomaly in offspring	16	98.1 58.2–165.5ROR 98.2 · calibrated p 7e-7 ✓	78.5 EB05 51.3 · IC025 +3.7 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=16	no trial data cached
Adrenal suppression	97	93.7 75.9–115.8ROR 94.1 · calibrated p 2e-7 ✓	81.7 EB05 68.9 · IC025 +5.5 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious n=94 · 96% clinician	no trial data cached
Chordee	16	93.3 55.4–157.1ROR 93.3 · calibrated p 1e-6 ✓	75.4 EB05 49.2 · IC025 +3.7 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=16	no trial data cached
Spine malformation	39	90.1 64.6–125.7ROR 90.2 · calibrated p 5e-7 ✓	77.1 EB05 58.9 · IC025 +4.8 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Not in label — unassessed	serious n=39	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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 interaction	2,556	11.8 11.4–12.3ROR 12.8 · calibrated p 0.013 ✓	11.6 EB05 11.2 · IC025 +3.5 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 38.3 (33.0–44.5)	Reporting / coding artifact	serious PRR 8.0 · 91% clinician	no trial data cached
Foetal exposure during pregnancy	2,390	21.9 21.0–22.7ROR 23.7 · calibrated p 9e-4 ✓	21.2 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 53.2 (44.4–63.7)	Reporting / coding artifact	serious PRR 13.4	no trial data cached
Anxiety	1,622	4.1 3.9–4.3ROR 4.3 · calibrated p 0.325	4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 10.9 (9.8–12.1)	Not in label — unassessed	serious PRR 3.7	no trial data cached
Pain	1,573	1.8 1.8–1.9ROR 1.9 · calibrated p 0.886	1.8 EB05 1.8 · IC025 +0.8 vs other Cytochrome P450 3A Inhibitors: PRR 9.7 (8.7–10.8)	Labeled adverse reaction exact term	serious PRR 1.8	no trial data cached
Emotional distress	1,388	8.3 7.9–8.8ROR 8.7 · calibrated p 0.051	8.2 EB05 7.9 · IC025 +3.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 8.8 (7.9–9.8)	Not in label — unassessed	serious PRR 5.7 · 100% consumer	no trial data cached
Maternal exposure during pregnancy	1,239	10.3 9.7–10.9ROR 10.7 · calibrated p 0.026 ✓	10.1 EB05 9.7 · IC025 +3.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: only this drug	Reporting / coding artifact	serious PRR 6.8 · ♀ 99% (drug 37%)	no trial data cached
Anhedonia	1,235	35.3 33.4–37.3ROR 36.8 · calibrated p 9e-5 ✓	33.6 EB05 32.1 · IC025 +5.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 8.4 (7.5–9.4)	Not in label — unassessed	serious PRR 22.7 · 100% consumer	no trial data cached
Nausea	1,056	1.0 0.9–1.0ROR 1.0 · calibrated p 0.284	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious PRR 1.0	no trial data cached
Diarrhoea (diarrhea)	1,022	1.1 1.1–1.2ROR 1.2 · calibrated p 0.408	1.1 EB05 1.1 · IC025 +0.1 vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious PRR 1.1	no trial data cached
Exposure during pregnancy	1,011	11.9 11.2–12.7ROR 12.3 · calibrated p 0.015 ✓	11.7 EB05 11.1 · IC025 +3.4 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 94.6 (65.4–136.8)	Reporting / coding artifact	serious PRR 9.9 · ♀ 99% (drug 37%)	no trial data cached
Renal failure (kidney failure)	950	5.2 4.8–5.5ROR 5.3 · calibrated p 0.205	5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 15.2 (12.9–17.8)	Labeled adverse reaction exact term	serious PRR 3.3	no trial data cached
Fatigue (tiredness)	906	0.8 0.8–0.9ROR 0.8 · calibrated p 0.205	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Cytochrome P450 3A Inhibitors: only this drug	Labeled adverse reaction exact term	serious PRR 0.9	no trial data cached
Acute kidney injury (sudden kidney damage)	901	4.3 4.0–4.6ROR 4.4 · calibrated p 0.312	4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 18.7 (15.6–22.4)	Labeled (related wording) related wording	serious PRR 2.7 · 90% clinician	no trial data cached
Chronic kidney disease	897	8.5 8.0–9.1ROR 8.8 · calibrated p 0.050 ✓	8.4 EB05 8.0 · IC025 +3.0 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 9.5 (8.3–10.9)	Not in label — unassessed	serious PRR 5.4	no trial data cached
Depression	868	2.7 2.6–2.9ROR 2.8 · calibrated p 0.694	2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Cytochrome P450 3A Inhibitors: PRR 16.0 (13.5–19.1)	Labeled adverse reaction exact term	serious PRR 2.3	no trial data cached

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.

Progressive external ophthalmoplegia — n=114, PRR 5,406.2
Aids encephalopathy — n=34, PRR 1,007.7
Ultrasound antenatal screen — n=54, PRR 960.3
Cloacal exstrophy — n=32, PRR 843.1
Bladder agenesis — n=33, PRR 572.5
Congenital naevus — n=43, PRR 332.5
Supernumerary nipple — n=25, PRR 329.3
Gastrointestinal disorder congenital — n=32, PRR 311.8
Hypercorticoidism — n=30, PRR 280.8
Csf hiv escape syndrome — n=39, PRR 280.2

✓ A hand-written Bradford Hill causality assessment exists for this drug: Nirmatrelvir/ritonavir (Paxlovid) ↔ COVID-19 recurrence ("Paxlovid rebound").

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 Ritonavir?

In FDA FAERS, the most frequently co-reported reaction terms for Ritonavir are anxiety, pain, emotional distress, anhedonia, nausea, diarrhoea. 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 Ritonavir have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid pr.

Do FAERS signals prove that Ritonavir 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 3c811e3e-f685-4af7-a4d1-037f2613ee68, effective 20250605; matched on openfda.generic_name.exact:"RITONAVIR")
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, 1,202 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

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.