Drug · FAERS side-effect profile with label screen
Lopinavir and Ritonavir side effects: what 13,476 FDA adverse event reports show
Drug class
Protease Inhibitor, Cytochrome P450 3A Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
13,476 reports · 92% serious · 1,776 with death outcome · 37% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV- 1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir.
FDA label, Indications and Usage
What it is
Lopinavir and ritonavir tablets, USP are a co-formulation of lopinavir USP and ritonavir USP. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir tablets, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.
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 2Labeled (related wording) 4Lab value / disease marker 2Not 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 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.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hepatic displacement | 16 | 3,069.3 1,313.8–7,170.5ROR 3,072.9 · χ² 15,351 / p <1e-300 | 459.2 EB05 299.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Diaphragmatic aplasia | 17 | 2,898.8 1,292.4–6,501.8ROR 2,902.4 · χ² 16,057 / p <1e-300 | 470.3 EB05 311.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Progressive external ophthalmoplegia | 82 | 2,677.4 1,871.4–3,830.7ROR 2,693.8 · χ² 78,959 / p <1e-300 | 793.9 EB05 659.8 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=82 · ♀ 0% (drug 37%) · 95% clinician | no trial arm names this drug |
| Ultrasound antenatal screen | 51 | 1,820.1 1,213.5–2,730.1ROR 1,827.1 · χ² 41,589 / p <1e-300 | 633.7 EB05 500.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=51 · 100% clinician | no trial arm names this drug |
| Hiv wasting syndrome | 15 | 1,096.2 565.2–2,125.9ROR 1,097.4 · χ² 8,945 / p <1e-300 | 352.1 EB05 226.5 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial arm names this drug |
| Spinocerebellar disorder | 17 | 869.6 479.8–1,576.3ROR 870.7 · χ² 8,868 / p <1e-300 | 341.6 EB05 225.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Total lung capacity increased | 95 | 833.1 649.3–1,068.9ROR 839.0 · χ² 50,636 / p <1e-300 | 487.1 EB05 410.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 100% (drug 37%) · 94% clinician | no trial arm names this drug |
| Aids encephalopathy | 20 | 807.7 470.1–1,387.7ROR 808.9 · χ² 10,035 / p <1e-300 | 351.3 EB05 240.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 10% (drug 37%) | no trial arm names this drug |
| Cardiac malposition | 23 | 666.0 408.4–1,086.1ROR 667.1 · χ² 10,191 / p <1e-300 | 335.1 EB05 235.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial arm names this drug |
| Mitochondrial toxicity | 177 | 427.8 362.4–504.9ROR 433.4 · χ² 58,602 / p <1e-300 | 323.0 EB05 285.0 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=177 · ♀ 3% (drug 37%) | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 95 | 347.9 278.7–434.5ROR 350.4 · χ² 26,509 / p <1e-300 | 268.5 EB05 226.2 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious n=95 · ♀ 100% (drug 37%) · 94% clinician | no trial arm names this drug |
| Alpha 1 foetoprotein abnormal | 15 | 270.8 156.5–468.8ROR 271.1 · χ² 3,202 / p <1e-300 | 178.4 EB05 114.8 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial arm names this drug |
| Lipodystrophy acquired | 291 | 246.0 217.7–278.1ROR 251.5 · χ² 61,001 / p <1e-300 | 209.3 EB05 189.9 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=285 · ♀ 12% (drug 37%) | no trial arm names this drug |
| Trisomy 18 | 51 | 238.6 177.7–320.3ROR 239.5 · χ² 10,239 / p <1e-300 | 191.9 EB05 151.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=51 · 91% clinician | no trial arm names this drug |
| Immune reconstitution syndrome | 137 | 182.2 152.7–217.3ROR 184.0 · χ² 21,906 / p <1e-300 | 159.4 EB05 138.2 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=133 | no trial arm names this drug |
| Neurodevelopmental disorder | 64 | 162.1 125.3–209.6ROR 162.8 · χ² 9,122 / p <1e-300 | 140.6 EB05 114.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=64 · 100% clinician | no trial arm names this drug |
| Bone demineralisation | 97 | 156.5 127.1–192.8ROR 157.7 · χ² 13,462 / p <1e-300 | 138.3 EB05 116.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=84 | no trial arm names this drug |
| Kaposi's sarcoma | 42 | 139.8 102.0–191.7ROR 140.2 · χ² 5,179 / p <1e-300 | 121.3 EB05 93.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 0% (drug 37%) · 100% clinician | no trial arm names this drug |
| Cushing's syndrome | 56 | 134.3 102.2–176.4ROR 134.8 · χ² 6,690 / p <1e-300 | 118.6 EB05 94.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=54 | no trial arm names this drug |
| Ergot poisoning | 10 | 133.4 69.9–254.6ROR 133.5 · χ² 1,091 / p 2e-239 | 100.0 EB05 58.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial arm names this drug |
| Deformity thorax | 15 | 130.1 76.8–220.2ROR 130.2 · χ² 1,654 / p <1e-300 | 104.4 EB05 67.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Acquired immunodeficiency syndrome | 39 | 127.6 92.1–176.8ROR 128.0 · χ² 4,407 / p <1e-300 | 111.6 EB05 85.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=39 · 93% clinician | no trial arm names this drug |
| Rickets | 14 | 122.8 71.3–211.5ROR 122.9 · χ² 1,455 / p <1e-300 | 98.8 EB05 62.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Pneumocystis carinii pneumonia | 15 | 122.4 72.4–207.1ROR 122.6 · χ² 1,563 / p <1e-300 | 99.5 EB05 64.0 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial arm names this drug |
| Portal fibrosis | 15 | 118.7 70.2–200.6ROR 118.8 · χ² 1,517 / p <1e-300 | 97.0 EB05 62.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Mitochondrial cytopathy | 31 | 116.6 81.0–167.9ROR 116.9 · χ² 3,195 / p <1e-300 | 101.8 EB05 75.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial arm names this drug |
| Fanconi syndrome acquired | 121 | 115.6 96.1–138.9ROR 116.6 · χ² 12,673 / p <1e-300 | 105.8 EB05 90.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=119 · 92% clinician | no trial arm names this drug |
| Ultrasound antenatal screen abnormal | 15 | 112.3 66.5–189.6ROR 112.4 · χ² 1,440 / p <1e-300 | 92.7 EB05 59.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Congenital hearing disorder | 11 | 111.8 60.6–206.1ROR 111.9 · χ² 1,025 / p 4e-225 | 88.7 EB05 52.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Cerebellar hypoplasia | 11 | 107.5 58.4–198.1ROR 107.6 · χ² 988 / p 5e-217 | 86.0 EB05 51.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Hydrops foetalis | 39 | 105.9 76.6–146.5ROR 106.2 · χ² 3,694 / p <1e-300 | 94.7 EB05 72.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | no trial arm names this drug |
| Psychiatric decompensation | 121 | 102.9 85.6–123.6ROR 103.8 · χ² 11,346 / p <1e-300 | 95.1 EB05 81.7 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=121 · ♀ 0% (drug 37%) · 96% clinician | no trial arm names this drug |
| Cd4 lymphocytes abnormal | 12 | 94.0 52.5–168.3ROR 94.0 · χ² 954 / p 8e-210 | 78.0 EB05 47.5 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial arm names this drug |
| Trisomy 21 | 72 | 93.7 73.9–118.8ROR 94.2 · χ² 6,138 / p <1e-300 | 86.4 EB05 70.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=72 | no trial arm names this drug |
| Human immunodeficiency virus transmission | 14 | 88.4 51.6–151.5ROR 88.5 · χ² 1,063 / p 2e-233 | 75.4 EB05 47.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Double outlet right ventricle | 15 | 81.9 48.7–137.7ROR 82.0 · χ² 1,063 / p 2e-233 | 71.1 EB05 45.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Polydactyly | 56 | 79.4 60.7–103.7ROR 79.7 · χ² 4,045 / p <1e-300 | 73.7 EB05 58.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=56 · 90% clinician | no trial arm names this drug |
| Exomphalos | 26 | 78.4 52.9–116.2ROR 78.5 · χ² 1,817 / p <1e-300 | 70.9 EB05 50.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial arm names this drug |
| Jaundice cholestatic | 168 | 77.5 66.4–90.4ROR 78.5 · χ² 12,004 / p <1e-300 | 73.2 EB05 64.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=168 · ♀ 100% (drug 37%) · 96% clinician | no trial arm names this drug |
| Hypomania | 172 | 76.1 65.4–88.6ROR 77.1 · χ² 12,078 / p <1e-300 | 72.0 EB05 63.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=172 · ♀ 100% (drug 37%) · 96% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Lopinavir and Ritonavir only as a background or rescue medication (NCT01061151, NCT00074581); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 | 1,337 | 13.2 12.6–13.9ROR 14.6 · χ² 15,071 / p <1e-300 | 13.1 EB05 12.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 · ♀ 13% (drug 37%) | no trial arm names this drug |
| Depression | 1,136 | 7.8 7.3–8.2ROR 8.4 · χ² 6,734 / p <1e-300 | 7.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 9% (drug 37%) | no trial arm names this drug |
| Nausea | 789 | 1.6 1.5–1.7ROR 1.6 · χ² 163 / p 2e-37 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Drug exposure during pregnancy | 777 | 35.8 33.4–38.4ROR 38.0 · χ² 25,725 / p <1e-300 | 35.0 EB05 33.0 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 23.2 · ♀ 71% (drug 37%) | no trial arm names this drug |
| Diarrhoea (diarrhea) | 775 | 1.9 1.8–2.0ROR 1.9 · χ² 326 / p 4e-73 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Foetal exposure during pregnancy | 753 | 14.5 13.6–15.6ROR 15.4 · χ² 9,436 / p <1e-300 | 14.4 EB05 13.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial arm names this drug |
| Anxiety | 713 | 3.9 3.6–4.2ROR 4.1 · χ² 1,550 / p <1e-300 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial arm names this drug |
| Vomiting | 711 | 2.4 2.2–2.5ROR 2.4 · χ² 569 / p 5e-126 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · ♀ 58% (drug 37%) | no trial arm names this drug |
| Off label use (used outside approved label) | 693 | 1.2 1.2–1.3ROR 1.3 · χ² 34 / p 3e-9 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.4 · 94% clinician | no trial arm names this drug |
| Pain | 693 | 1.8 1.6–1.9ROR 1.8 · χ² 230 / p 3e-52 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Emotional distress | 578 | 7.4 6.9–8.1ROR 7.7 · χ² 3,215 / p <1e-300 | 7.4 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% consumer | no trial arm names this drug |
| Renal failure (kidney failure) | 541 | 6.3 5.8–6.9ROR 6.5 · χ² 2,420 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial arm names this drug |
| Pyrexia (fever) | 528 | 2.4 2.2–2.6ROR 2.4 · χ² 425 / p 8e-95 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial arm names this drug |
| Anhedonia | 510 | 30.5 28.0–33.3ROR 31.7 · χ² 14,275 / p <1e-300 | 29.9 EB05 27.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · 100% consumer | no trial arm names this drug |
| Anaemia (low red blood cells) | 451 | 3.7 3.4–4.0ROR 3.8 · χ² 885 / p 9e-195 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial arm names this drug |
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=82, PRR 2,677.4
- Ultrasound antenatal screen — n=51, PRR 1,820.1
- Total lung capacity increased — n=95, PRR 833.1
- Aids encephalopathy — n=20, PRR 807.7
- Cardiac malposition — n=23, PRR 666.0
- Mitochondrial toxicity — n=177, PRR 427.8
- Trisomy 18 — n=51, PRR 238.6
- Neurodevelopmental disorder — n=64, PRR 162.1
- Bone demineralisation — n=97, PRR 156.5
- Kaposi's sarcoma — n=42, PRR 139.8
✓ 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 Lopinavir and Ritonavir?
In FDA FAERS, the most frequently co-reported reaction terms for Lopinavir and Ritonavir are depression, nausea, diarrhoea, anxiety, vomiting, 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 Lopinavir and Ritonavir have an FDA boxed warning?
No. The FDA label retrieved for Lopinavir and Ritonavir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lopinavir and 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 a7072c60-6dbf-4125-95e7-497c05a9e6a6, effective 20231020; matched on
openfda.generic_name.exact:"LOPINAVIR AND 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, 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 - ClinicalTrials.gov API v2 (query
LOPINAVIR, 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.