Drug · FAERS side-effect profile with label screen
Ribociclib side effects: what 31,373 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Kisqali
openFDA label
Who reports
31,373 reports · 83% serious · 4,597 with death outcome · 99% female
openFDA FAERS counts, all years, deduplication not applied
Used for
KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
FDA label, Indications and Usage
What it is
KISQALI (ribociclib) is a kinase inhibitor.
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 (related wording) 1Likely indication confounding 4Lab value / disease marker 7Not in label — unassessed 28
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.
- 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). 1,111 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 |
|---|---|---|---|---|---|---|
| Hormone receptor positive her2 negative breast cancer | 197 | 1,147.9 911.1–1,446.3ROR 1,155.2 · calibrated p 1e-17 ✓ | 402.6 EB05 357.6 · IC025 +7.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=197 | not reported in cached trials |
| Elliptocytosis | 45 | 673.4 444.5–1,020.2ROR 674.4 · calibrated p 3e-14 ✓ | 292.0 EB05 227.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=45 | not reported in cached trials |
| Rouleaux formation | 25 | 498.8 296.7–838.7ROR 499.2 · calibrated p 2e-12 ✓ | 233.6 EB05 166.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Her2 negative breast cancer | 20 | 487.8 273.6–869.5ROR 488.1 · calibrated p 4e-12 ✓ | 221.5 EB05 151.4 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=20 | not reported in cached trials |
| Eastern cooperative oncology group performance status abnormal | 48 | 439.0 304.7–632.4ROR 439.6 · calibrated p 1e-12 ✓ | 238.8 EB05 187.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=47 · 100% consumer | not reported in cached trials |
| Carbohydrate antigen 15-3 increased | 240 | 308.7 264.9–359.7ROR 311.0 · calibrated p 9e-12 ✓ | 207.0 EB05 185.9 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=238 | not reported in cached trials |
| Pik3ca-activated mutation | 88 | 247.6 193.8–316.3ROR 248.3 · calibrated p 1e-10 ✓ | 173.5 EB05 145.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=88 | not reported in cached trials |
| Tumour marker decreased | 45 | 221.1 157.8–309.9ROR 221.4 · calibrated p 5e-10 ✓ | 155.0 EB05 120.6 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=36 · 76% consumer | not reported in cached trials |
| Tumour marker abnormal | 57 | 137.0 103.0–182.2ROR 137.2 · calibrated p 2e-8 ✓ | 109.5 EB05 87.6 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=54 · 79% consumer | not reported in cached trials |
| Metastases to breast | 52 | 126.3 93.9–170.0ROR 126.6 · calibrated p 4e-8 ✓ | 102.3 EB05 81.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=52 · 83% consumer | not reported in cached trials |
| Poikilocytosis | 43 | 123.1 88.9–170.5ROR 123.3 · calibrated p 5e-8 ✓ | 99.4 EB05 76.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Metastases to thorax | 39 | 121.1 86.1–170.4ROR 121.3 · calibrated p 6e-8 ✓ | 97.7 EB05 74.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Breast cancer metastatic | 1,625 | 119.4 113.4–125.7ROR 125.8 · calibrated p 2e-8 ✓ | 101.1 EB05 97.0 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 71.9 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Metastases to neck | 38 | 105.1 74.7–148.0ROR 105.3 · calibrated p 2e-7 ✓ | 86.9 EB05 66.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% consumer | not reported in cached trials |
| Metastases to pelvis | 80 | 97.0 76.7–122.6ROR 97.3 · calibrated p 2e-7 ✓ | 83.1 EB05 68.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=80 · 72% consumer | not reported in cached trials |
| Electrocardiogram qt interval abnormal | 62 | 95.4 73.1–124.5ROR 95.6 · calibrated p 3e-7 ✓ | 81.4 EB05 65.8 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=62 | not reported in cached trials |
| Hormone receptor positive breast cancer | 32 | 92.4 63.8–133.8ROR 92.5 · calibrated p 5e-7 ✓ | 77.5 EB05 57.5 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications | serious n=32 · 100% clinician | not reported in cached trials |
| Anisocytosis | 78 | 91.2 72.0–115.6ROR 91.5 · calibrated p 3e-7 ✓ | 78.8 EB05 65.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=78 | not reported in cached trials |
| Electrocardiogram pr shortened | 25 | 90.0 59.2–136.6ROR 90.0 · calibrated p 7e-7 ✓ | 74.9 EB05 53.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Metastases to bone | 1,767 | 80.9 77.1–84.9ROR 85.7 · calibrated p 4e-7 ✓ | 72.1 EB05 69.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.8 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Bone marrow infiltration | 41 | 79.4 57.4–109.8ROR 79.5 · calibrated p 1e-6 ✓ | 68.8 EB05 52.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Decreased immune responsiveness | 1,022 | 78.1 73.2–83.2ROR 80.6 · calibrated p 6e-7 ✓ | 69.8 EB05 66.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 58.5 · 92% consumer | not reported in cached trials |
| Basophil percentage increased | 18 | 78.0 47.8–127.1ROR 78.0 · calibrated p 3e-6 ✓ | 65.2 EB05 43.6 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=18 | not reported in cached trials |
| Bone sequestrum | 16 | 77.5 46.2–130.0ROR 77.5 · calibrated p 3e-6 ✓ | 64.3 EB05 42.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Metastases to spine | 342 | 75.9 67.9–84.9ROR 76.8 · calibrated p 8e-7 ✓ | 67.9 EB05 62.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=341 · 78% consumer | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Metastases to pleura | 105 | 74.9 61.2–91.6ROR 75.2 · calibrated p 1e-6 ✓ | 66.6 EB05 56.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=104 | not reported in cached trials |
| Invasive breast carcinoma | 40 | 71.6 51.7–99.2ROR 71.7 · calibrated p 2e-6 ✓ | 62.8 EB05 48.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Polychromasia | 28 | 68.3 46.3–100.8ROR 68.3 · calibrated p 4e-6 ✓ | 59.6 EB05 43.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Metastases to spinal cord | 18 | 68.1 41.9–110.7ROR 68.2 · calibrated p 6e-6 ✓ | 58.2 EB05 39.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Metastases to ovary | 29 | 67.2 45.9–98.5ROR 67.3 · calibrated p 4e-6 ✓ | 58.9 EB05 43.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Pyelitis | 18 | 63.4 39.1–102.8ROR 63.4 · calibrated p 9e-6 ✓ | 54.7 EB05 36.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Metastases to the mediastinum | 35 | 61.5 43.5–86.9ROR 61.5 · calibrated p 7e-6 ✓ | 54.7 EB05 41.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Positron emission tomogram abnormal | 56 | 58.9 44.8–77.4ROR 59.0 · calibrated p 7e-6 ✓ | 53.2 EB05 42.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=54 · 100% consumer | not reported in cached trials |
| Breast inflammation | 24 | 57.1 37.6–86.6ROR 57.1 · calibrated p 1e-5 ✓ | 50.6 EB05 35.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Carcinoembryonic antigen increased | 151 | 56.7 48.0–66.9ROR 56.9 · calibrated p 7e-6 ✓ | 51.9 EB05 45.3 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=151 | not reported in cached trials |
| Breast cancer recurrent | 234 | 53.6 46.9–61.2ROR 54.0 · calibrated p 9e-6 ✓ | 49.4 EB05 44.3 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=234 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Bone lesion | 262 | 52.3 46.1–59.3ROR 52.7 · calibrated p 1e-5 ✓ | 48.3 EB05 43.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=259 | not reported in cached trials |
| Eastern cooperative oncology group performance status worsened | 90 | 52.1 42.1–64.6ROR 52.3 · calibrated p 1e-5 ✓ | 47.9 EB05 40.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=90 · 100% clinician | not reported in cached trials |
| Metastases to bone marrow | 36 | 51.4 36.6–72.2ROR 51.5 · calibrated p 2e-5 ✓ | 46.7 EB05 35.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Tumour marker increased | 341 | 50.9 45.7–56.9ROR 51.5 · calibrated p 1e-5 ✓ | 47.2 EB05 43.2 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=312 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ribociclib 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 (5 of 40 signal terms matched).
- NCT02941926 — Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment (N=3246, PHASE3; 461 AE terms posted; arms: All Patients- On-treatment Core Phase; All Patients- On-treatment Extension Pha; All-patients- Post-treatment Survival Fo; All-patients- Post-treatment Survival Fo)
- NCT02422615 — Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (N=726, PHASE3; 305 AE terms posted; arms: Ribociclib + Fulvestrant (On-treatment); Ribociclib + Fulvestrant (Post-treatment; Placebo + Fulvestrant (On-treatment); Placebo + Fulvestrant (Post-treatment Ef)
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 |
|---|---|---|---|---|---|---|
| Neutropenia (low neutrophils (infection-fighting cells)) | 4,093 | 20.8 20.2–21.4ROR 23.8 · calibrated p 9e-4 ✓ | 20.2 EB05 19.7 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.5 | NCT02941926: 21/3,246 (0.6%) on Ribociclib (serious AE) |
| Fatigue (tiredness) | 3,813 | 3.3 3.2–3.4ROR 3.6 · calibrated p 0.459 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | NCT02941926: 5/3,246 (0.2%) on Ribociclib (serious AE) |
| Nausea | 3,805 | 3.2 3.1–3.3ROR 3.5 · calibrated p 0.474 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | NCT02941926: 12/3,246 (0.4%) on Ribociclib (serious AE) |
| Malignant neoplasm progression | 2,749 | 18.5 17.9–19.2ROR 20.2 · calibrated p 0.002 ✓ | 18.0 EB05 17.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.7 | NCT02941926: 3/3,246 (0.1%) on Ribociclib (serious AE) |
| Death | 2,510 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.962 | 1.9 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction | serious PRR 1.4 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Vomiting | 2,149 | 3.1 2.9–3.2ROR 3.2 · calibrated p 0.558 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | NCT02941926: 31/3,246 (1.0%) on Ribociclib (serious AE) |
| Diarrhoea (diarrhea) | 2,069 | 2.2 2.1–2.2ROR 2.2 · calibrated p 0.934 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | NCT02941926: 14/3,246 (0.4%) on Ribociclib (serious AE) |
| White blood cell count decreased | 1,971 | 12.3 11.8–12.9ROR 13.1 · calibrated p 0.012 ✓ | 12.1 EB05 11.7 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.5 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Pain | 1,877 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.998 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Metastases to bone | 1,767 | 80.9 77.1–84.9ROR 85.7 · calibrated p 4e-7 ✓ | 72.1 EB05 69.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.8 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Breast cancer metastatic | 1,625 | 119.4 113.4–125.7ROR 125.8 · calibrated p 2e-8 ✓ | 101.1 EB05 97.0 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 71.9 | NCT02941926: 1/3,246 (0.0%) on Ribociclib (serious AE) |
| Asthenia (weakness) | 1,612 | 2.9 2.7–3.0ROR 3.0 · calibrated p 0.635 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | NCT02941926: 6/3,246 (0.2%) on Ribociclib (serious AE) |
| Malaise (feeling unwell) | 1,603 | 2.4 2.3–2.6ROR 2.5 · calibrated p 0.805 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 80% consumer | NCT02941926: 3/3,246 (0.1%) on Ribociclib (serious AE) |
| Dyspnoea (shortness of breath) | 1,602 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.913 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT02941926: 45/3,246 (1.4%) on Ribociclib (serious AE) |
| Anaemia (low red blood cells) | 1,511 | 5.3 5.1–5.6ROR 5.5 · calibrated p 0.183 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | NCT02941926: 24/3,246 (0.7%) on Ribociclib (serious AE) |
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.
- Elliptocytosis — n=45, PRR 673.4
- Rouleaux formation — n=25, PRR 498.8
- Eastern cooperative oncology group performance status abnormal — n=48, PRR 439.0
- Pik3ca-activated mutation — n=88, PRR 247.6
- Metastases to breast — n=52, PRR 126.3
- Poikilocytosis — n=43, PRR 123.1
- Metastases to thorax — n=39, PRR 121.1
- Metastases to neck — n=38, PRR 105.1
- Metastases to pelvis — n=80, PRR 97.0
- Anisocytosis — n=78, PRR 91.2
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 Ribociclib?
In FDA FAERS, the most frequently co-reported reaction terms for Ribociclib are neutropenia, fatigue, nausea, vomiting, diarrhoea, white blood cell count decreased. 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 Ribociclib have an FDA boxed warning?
No. The FDA label retrieved for Ribociclib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ribociclib 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 aaeaef94-f3f5-4367-8ea2-b181d7be2da8, effective 20260701; matched on
openfda.generic_name.exact:"RIBOCICLIB") - 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, 1,151 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
RIBOCICLIB, 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.