Ritonavir 100 side effects: what 14,851 FDA adverse event reports show
Drug class
Cytochrome P450 3A Inhibitor, Protease Inhibitor
Label matched
Ritonavir 100 Mg (Ritonavir Film Coated)
Who reports
14,851 reports · 92% serious · 1,446 with death outcome · 39% female
Used for
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Ritonavir tablets are HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 ).
What it is
Ritonavir is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV). Ritonavir is chemically designated as 2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-.
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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,034 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 |
|---|---|---|---|---|---|---|
| Progressive external ophthalmoplegia | 104 | 5,791.8 3,744.0–8,959.6ROR 5,832.6 · χ² 115,574 / p <1e-300 | 929.5 EB05 789.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=104 · ♀ 0% (drug 39%) · 96% clinician | no trial data cached |
| Ultrasound antenatal screen | 54 | 1,879.6 1,249.2–2,828.1ROR 1,886.4 · χ² 42,348 / p <1e-300 | 622.6 EB05 495.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=54 · 100% clinician | no trial data cached |
| Glucocorticoids increased | 11 | 1,701.7 705.2–4,105.8ROR 1,702.9 · χ² 7,665 / p <1e-300 | 328.4 EB05 195.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Cd4/cd8 ratio decreased | 96 | 1,272.9 965.6–1,678.0ROR 1,281.2 · χ² 63,073 / p <1e-300 | 587.1 EB05 495.0 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=96 | no trial data cached |
| Blood hiv rna | 15 | 580.1 317.7–1,059.3ROR 580.7 · χ² 5,719 / p <1e-300 | 269.3 EB05 173.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Csf hiv escape syndrome | 39 | 548.5 378.8–794.2ROR 549.9 · χ² 14,899 / p <1e-300 | 329.9 EB05 251.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | no trial data cached |
| Aids encephalopathy | 15 | 485.7 269.9–874.0ROR 486.2 · χ² 5,025 / p <1e-300 | 247.1 EB05 159.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Ergot poisoning | 21 | 281.1 175.9–449.2ROR 281.5 · χ² 4,647 / p <1e-300 | 193.2 EB05 133.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Scrotal cyst | 13 | 251.4 139.3–453.7ROR 251.6 · χ² 2,538 / p <1e-300 | 162.7 EB05 101.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mitochondrial toxicity | 118 | 236.7 194.9–287.6ROR 238.6 · χ² 23,473 / p <1e-300 | 196.1 EB05 168.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=118 · ♀ 5% (drug 39%) · 93% clinician | no trial data cached |
| Cd4 lymphocytes abnormal | 29 | 225.6 152.4–333.8ROR 226.0 · χ² 5,388 / p <1e-300 | 172.4 EB05 125.9 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=29 | no trial data cached |
| Virologic failure | 685 | 205.5 190.0–222.3ROR 215.4 · χ² 121,321 / p <1e-300 | 178.3 EB05 167.4 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=675 · 97% clinician | no trial data cached |
| Lipodystrophy acquired | 263 | 198.7 174.8–225.9ROR 202.2 · χ² 45,100 / p <1e-300 | 171.8 EB05 155.1 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=263 · ♀ 14% (drug 39%) | no trial data cached |
| Pulmonary haemorrhage neonatal | 11 | 193.9 103.2–364.2ROR 194.0 · χ² 1,687 / p <1e-300 | 131.9 EB05 78.6 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Alpha 1 foetoprotein abnormal | 12 | 189.9 103.9–347.0ROR 190.0 · χ² 1,821 / p <1e-300 | 132.5 EB05 80.8 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Ectopic kidney | 11 | 189.1 100.7–354.9ROR 189.2 · χ² 1,650 / p <1e-300 | 129.7 EB05 77.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hiv-associated neurocognitive disorder | 13 | 184.7 103.6–329.3ROR 184.8 · χ² 1,938 / p <1e-300 | 132.0 EB05 82.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Retinoblastoma | 12 | 174.0 95.5–317.1ROR 174.2 · χ² 1,684 / p <1e-300 | 124.6 EB05 76.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cushing's syndrome | 77 | 173.2 136.7–219.4ROR 174.1 · χ² 11,571 / p <1e-300 | 148.5 EB05 122.7 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=76 | no trial data cached |
| Immune reconstitution syndrome | 138 | 166.6 139.8–198.7ROR 168.2 · χ² 20,145 / p <1e-300 | 146.0 EB05 126.6 · IC025 +6.3 3/3 methods agree | Labeled — boxed warning exact term | serious n=136 | no trial data cached |
| Trisomy 18 | 40 | 164.3 118.4–227.9ROR 164.7 · χ² 5,661 / p <1e-300 | 137.5 EB05 105.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | no trial data cached |
| Chordee | 14 | 157.2 90.5–273.1ROR 157.3 · χ² 1,814 / p <1e-300 | 118.9 EB05 75.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Adrenal suppression | 82 | 152.0 121.1–190.8ROR 152.9 · χ² 10,956 / p <1e-300 | 133.0 EB05 110.5 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=81 · 95% clinician | no trial data cached |
| Ventricular hypoplasia | 24 | 150.5 98.8–229.3ROR 150.8 · χ² 3,083 / p <1e-300 | 122.9 EB05 86.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Hypercorticoidism | 10 | 145.0 75.6–278.1ROR 145.1 · χ² 1,168 / p 3e-256 | 105.6 EB05 61.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Teratogenicity | 28 | 143.8 97.5–212.2ROR 144.1 · χ² 3,472 / p <1e-300 | 120.0 EB05 87.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Cd4 lymphocytes decreased | 186 | 133.1 114.6–154.6ROR 134.8 · χ² 22,146 / p <1e-300 | 120.1 EB05 106.3 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=181 | no trial data cached |
| Genitalia external ambiguous | 15 | 132.2 77.9–224.4ROR 132.3 · χ² 1,666 / p <1e-300 | 105.0 EB05 67.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Congenital naevus | 11 | 123.5 66.7–228.8ROR 123.6 · χ² 1,118 / p 2e-245 | 95.3 EB05 56.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Psychiatric decompensation | 151 | 118.4 100.4–139.7ROR 119.6 · χ² 16,099 / p <1e-300 | 107.8 EB05 94.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=151 · ♀ 2% (drug 39%) · 96% clinician | no trial data cached |
| Blood hiv rna increased | 138 | 117.7 99.0–140.0ROR 118.8 · χ² 14,620 / p <1e-300 | 107.1 EB05 92.9 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=136 · 90% clinician | no trial data cached |
| Hiv viraemia | 16 | 117.2 70.4–195.2ROR 117.4 · χ² 1,595 / p <1e-300 | 96.1 EB05 62.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Hydrops foetalis | 40 | 98.7 71.7–136.0ROR 99.0 · χ² 3,523 / p <1e-300 | 88.5 EB05 67.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | no trial data cached |
| Nephroangiosclerosis | 10 | 95.4 50.3–180.9ROR 95.4 · χ² 788 / p 1e-173 | 76.7 EB05 44.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Viral mutation identified | 232 | 94.1 82.5–107.4ROR 95.6 · χ² 19,936 / p <1e-300 | 87.6 EB05 78.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=232 · 92% clinician | no trial data cached |
| Laryngomalacia | 21 | 93.4 60.1–145.3ROR 93.5 · χ² 1,714 / p <1e-300 | 81.3 EB05 56.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 0% (drug 39%) · 100% clinician | no trial data cached |
| Renal tubular dysfunction | 34 | 91.6 64.7–129.5ROR 91.8 · χ² 2,773 / p <1e-300 | 82.1 EB05 61.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=34 · 100% clinician | no trial data cached |
| Renal dysplasia | 23 | 89.9 59.0–137.1ROR 90.1 · χ² 1,818 / p <1e-300 | 79.2 EB05 55.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Foetal chromosome abnormality | 10 | 88.7 46.8–168.0ROR 88.7 · χ² 735 / p 4e-162 | 72.4 EB05 42.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Ultrasound antenatal screen abnormal | 13 | 87.4 49.9–153.1ROR 87.5 · χ² 965 / p 3e-212 | 73.8 EB05 45.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 2,046 | 18.4 17.7–19.2ROR 21.2 · χ² 33,529 / p <1e-300 | 18.2 EB05 17.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.4 · 94% clinician | no trial data cached |
| Foetal exposure during pregnancy | 1,305 | 23.0 21.9–24.3ROR 25.2 · χ² 27,145 / p <1e-300 | 22.7 EB05 21.7 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Maternal exposure during pregnancy | 702 | 11.3 10.5–12.2ROR 11.8 · χ² 6,569 / p <1e-300 | 11.2 EB05 10.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · ♀ 99% (drug 39%) | no trial data cached |
| Virologic failure | 685 | 205.5 190.0–222.3ROR 215.4 · χ² 121,321 / p <1e-300 | 178.3 EB05 167.4 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious n=675 · 97% clinician | no trial data cached |
| Exposure during pregnancy | 646 | 14.8 13.7–16.0ROR 15.4 · χ² 8,243 / p <1e-300 | 14.7 EB05 13.7 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 · ♀ 98% (drug 39%) | no trial data cached |
| Off label use (used outside approved label) | 562 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.016 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 92% clinician | no trial data cached |
| Drug resistance | 555 | 31.2 28.7–33.8ROR 32.3 · χ² 15,840 / p <1e-300 | 30.5 EB05 28.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.8 | no trial data cached |
| Nausea | 516 | 0.9 0.8–1.0ROR 0.9 · χ² 3 / p 0.034 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Diarrhoea (diarrhea) | 511 | 1.1 1.0–1.2ROR 1.1 · χ² 7 / p 0.004 | 1.1 EB05 1.0 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 475 | 4.4 4.0–4.8ROR 4.5 · χ² 1,256 / p 2e-275 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · 96% clinician | no trial data cached |
| Premature baby | 456 | 21.6 19.8–23.7ROR 22.3 · χ² 8,831 / p <1e-300 | 21.3 EB05 19.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Toxicity to various agents | 451 | 3.8 3.5–4.2ROR 3.9 · χ² 933 / p 3e-205 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 · 98% clinician | no trial data cached |
| Abortion spontaneous | 415 | 14.7 13.4–16.2ROR 15.1 · χ² 5,242 / p <1e-300 | 14.5 EB05 13.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 98% (drug 39%) | no trial data cached |
| Vomiting | 408 | 1.2 1.1–1.4ROR 1.2 · χ² 18 / p 1e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Anaemia (low red blood cells) | 401 | 3.0 2.7–3.3ROR 3.0 · χ² 526 / p 1e-116 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | 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=104, PRR 5,791.8
- Ultrasound antenatal screen — n=54, PRR 1,879.6
- Csf hiv escape syndrome — n=39, PRR 548.5
- Ergot poisoning — n=21, PRR 281.1
- Mitochondrial toxicity — n=118, PRR 236.7
- Trisomy 18 — n=40, PRR 164.3
- Ventricular hypoplasia — n=24, PRR 150.5
- Teratogenicity — n=28, PRR 143.8
- Psychiatric decompensation — n=151, PRR 118.4
- Hydrops foetalis — n=40, PRR 98.7
✓ 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 100?
In FDA FAERS, the most frequently co-reported reaction terms for Ritonavir 100 are virologic failure, nausea, diarrhoea, acute kidney injury, premature baby, toxicity to various agents. 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 100 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 100 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 4633c6ba-168d-426f-acae-7843e167743a, effective 20230301; matched on
openfda.generic_name.exact:"RITONAVIR 100 MG") - 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, 1,074 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 2026-10-08. 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.