Cetuximab side effects: what 31,149 FDA adverse event reports show
Drug class
Epidermal Growth Factor Receptor Antagonist
Brand names
Erbitux
Who reports
31,149 reports · 85% serious · 4,217 with death outcome · 34% female
Used for
ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.
What it is
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist. It is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR).
Boxed warning
INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] .
Causality screen of the 40 strongest signals
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.
- 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 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 |
|---|---|---|---|---|---|---|
| Radiation mucositis | 43 | 241.7 170.5–342.6ROR 242.0 · χ² 7,379 / p <1e-300 | 164.6 EB05 127.3 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=43 | not reported in cached trials |
| Radiation skin injury | 213 | 151.4 130.5–175.7ROR 152.5 · χ² 25,792 / p <1e-300 | 122.1 EB05 109.0 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=198 | not reported in cached trials |
| Trichomegaly | 16 | 139.6 81.5–239.4ROR 139.7 · χ² 1,706 / p <1e-300 | 101.8 EB05 66.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Dermatitis acneiform | 852 | 110.4 102.7–118.6ROR 113.5 · χ² 79,099 / p <1e-300 | 94.6 EB05 89.4 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=612 | not reported in cached trials |
| Serous retinal detachment | 105 | 102.4 83.4–125.8ROR 102.8 · χ² 9,047 / p <1e-300 | 87.5 EB05 74.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=105 · 92% clinician | not reported in cached trials |
| Squamous cell carcinoma of head and neck | 25 | 80.9 53.4–122.5ROR 81.0 · χ² 1,688 / p <1e-300 | 68.6 EB05 48.9 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=24 · 100% clinician | not reported in cached trials |
| Portal venous gas | 24 | 49.1 32.5–74.4ROR 49.2 · χ² 1,009 / p 9e-222 | 44.3 EB05 31.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 34%) | not reported in cached trials |
| Nail bed inflammation | 21 | 47.5 30.5–74.0ROR 47.6 · χ² 850 / p 4e-187 | 42.8 EB05 29.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Skin toxicity | 359 | 46.3 41.6–51.5ROR 46.8 · χ² 14,824 / p <1e-300 | 43.2 EB05 39.6 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=341 | not reported in cached trials |
| Mucosal infection | 15 | 46.1 27.3–77.7ROR 46.1 · χ² 577 / p 9e-128 | 41.1 EB05 26.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | NCT00265850: 2/578 (0.3%) on Cetuximab |
| Pharyngeal inflammation | 77 | 45.8 36.3–57.6ROR 45.9 · χ² 3,112 / p <1e-300 | 42.5 EB05 35.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=76 · ♀ 10% (drug 34%) | not reported in cached trials |
| Paronychia | 262 | 43.3 38.3–49.1ROR 43.7 · χ² 10,137 / p <1e-300 | 40.6 EB05 36.7 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=234 | not reported in cached trials |
| Osteoradionecrosis | 13 | 41.1 23.5–71.9ROR 41.1 · χ² 441 / p 3e-98 | 36.8 EB05 22.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Granulocyte count decreased | 98 | 39.1 31.9–48.0ROR 39.3 · χ² 3,403 / p <1e-300 | 36.8 EB05 31.1 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=98 · 82% consumer | not reported in cached trials |
| Colorectal cancer metastatic | 123 | 38.2 31.9–45.8ROR 38.4 · χ² 4,180 / p <1e-300 | 36.0 EB05 31.0 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=123 · ♀ 56% (drug 34%) · 93% clinician | not reported in cached trials |
| Haemoglobin | 10 | 35.5 18.8–67.0ROR 35.5 · χ² 286 / p 2e-64 | 31.8 EB05 18.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT00079274: 1/1,326 (0.1%) on Cetuximab (serious AE) |
| Hepatectomy | 14 | 32.4 18.9–55.3ROR 32.4 · χ² 376 / p 4e-84 | 29.8 EB05 18.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Hypomagnesaemia | 596 | 30.2 27.8–32.7ROR 30.8 · χ² 16,069 / p <1e-300 | 28.9 EB05 27.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | not reported in cached trials |
| Skin chapped | 17 | 29.1 17.9–47.4ROR 29.2 · χ² 416 / p 1e-92 | 27.2 EB05 17.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Catheter related infection | 38 | 25.9 18.7–35.8ROR 25.9 · χ² 851 / p 2e-187 | 24.7 EB05 18.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=38 | NCT00079274: 1/1,378 (0.1%) on Cetuximab (serious AE) |
| Feeding tube complication | 11 | 24.3 13.3–44.4ROR 24.3 · χ² 215 / p 5e-49 | 22.5 EB05 13.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=10 | not reported in cached trials |
| Rectal cancer metastatic | 12 | 24.1 13.6–42.9ROR 24.1 · χ² 235 / p 3e-53 | 22.4 EB05 13.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=12 | not reported in cached trials |
| Cutaneous symptom | 23 | 23.9 15.8–36.3ROR 24.0 · χ² 466 / p 1e-103 | 22.8 EB05 15.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=23 | not reported in cached trials |
| Nail toxicity | 10 | 23.4 12.4–43.9ROR 23.4 · χ² 186 / p 1e-42 | 21.4 EB05 11.8 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Mucosal inflammation | 825 | 22.0 20.5–23.5ROR 22.6 · χ² 15,991 / p <1e-300 | 21.3 EB05 20.1 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 | not reported in cached trials |
| Oncologic complication | 29 | 20.6 14.3–29.9ROR 20.7 · χ² 507 / p 2e-112 | 19.8 EB05 14.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=29 · ♀ 0% (drug 34%) · 100% consumer | not reported in cached trials |
| Mesenteric artery thrombosis | 11 | 19.8 10.9–36.0ROR 19.8 · χ² 173 / p 1e-39 | 18.2 EB05 10.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Pneumatosis intestinalis | 81 | 19.7 15.8–24.6ROR 19.8 · χ² 1,382 / p <1e-300 | 19.1 EB05 15.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=81 | not reported in cached trials |
| Necrotising oesophagitis | 14 | 19.7 11.6–33.5ROR 19.7 · χ² 224 / p 7e-51 | 18.5 EB05 11.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Rectal adenocarcinoma | 17 | 19.7 12.1–31.9ROR 19.7 · χ² 275 / p 5e-62 | 18.6 EB05 12.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Blood pressure immeasurable | 41 | 18.4 13.5–25.1ROR 18.4 · χ² 639 / p 3e-141 | 17.8 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Carcinoembryonic antigen increased | 51 | 18.2 13.8–24.1ROR 18.3 · χ² 792 / p 2e-174 | 17.7 EB05 13.9 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=44 | not reported in cached trials |
| Radiation oesophagitis | 10 | 18.2 9.7–34.1ROR 18.2 · χ² 142 / p 6e-33 | 16.3 EB05 8.4 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Proteus infection | 19 | 18.2 11.5–28.6ROR 18.2 · χ² 283 / p 7e-64 | 17.2 EB05 11.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Metastatic squamous cell carcinoma | 13 | 17.5 10.1–30.4ROR 17.5 · χ² 182 / p 1e-41 | 16.2 EB05 9.3 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=13 | not reported in cached trials |
| Nail dystrophy | 14 | 17.4 10.2–29.6ROR 17.4 · χ² 195 / p 1e-44 | 16.2 EB05 9.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Metastases to the mediastinum | 10 | 16.6 8.9–31.1ROR 16.6 · χ² 128 / p 6e-30 | 14.7 EB05 7.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Colon cancer metastatic | 38 | 16.3 11.8–22.5ROR 16.3 · χ² 518 / p 7e-115 | 15.7 EB05 11.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | not reported in cached trials |
| Blood magnesium abnormal | 13 | 16.2 9.4–28.1ROR 16.2 · χ² 167 / p 2e-38 | 14.8 EB05 8.4 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | – | NCT00079274: 1/1,378 (0.1%) on Cetuximab (serious AE) |
| Abdominal compartment syndrome | 14 | 15.5 9.1–26.2ROR 15.5 · χ² 171 / p 2e-39 | 14.1 EB05 8.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 | 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 Cetuximab 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 (4 of 40 signal terms matched).
- NCT00079274 — Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Underg (N=3397, PHASE3; 336 AE terms posted; arms: Arm A (Combination Chemotherapy); Arm B (Combination Chemotherapy); Arm C (Combination Chemotherapy); Arm D (Combination Chemotherapy, Monoclo)
- NCT00265850 — Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Color (N=2334, PHASE3; 454 AE terms posted; arms: Arm A: FOLFOX or FOLFIRI + Bevacizumab; Arm B: FOLFOX or FOLFIRI + Cetuximab)
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 |
|---|---|---|---|---|---|---|
| Rash | 2,273 | 3.5 3.4–3.7ROR 3.7 · χ² 4,210 / p <1e-300 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | NCT00079274: 1/1,326 (0.1%) on Cetuximab (serious AE) |
| Diarrhoea (diarrhea) | 2,023 | 2.1 2.0–2.2ROR 2.2 · χ² 1,231 / p 5e-270 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00079274: 15/1,378 (1.1%) on Cetuximab (serious AE) |
| Off label use (used outside approved label) | 1,890 | 1.5 1.4–1.5ROR 1.5 · χ² 292 / p 9e-66 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Nausea | 1,645 | 1.4 1.3–1.5ROR 1.4 · χ² 198 / p 2e-45 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00079274: 5/1,378 (0.4%) on Cetuximab (serious AE) |
| Vomiting | 1,394 | 2.0 1.9–2.1ROR 2.1 · χ² 715 / p 1e-157 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00079274: 3/1,378 (0.2%) on Cetuximab (serious AE) |
| Dyspnoea (shortness of breath) | 1,385 | 1.7 1.6–1.7ROR 1.7 · χ² 363 / p 3e-81 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00079274: 2/1,378 (0.1%) on Cetuximab (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 1,225 | 6.1 5.8–6.5ROR 6.3 · χ² 5,244 / p <1e-300 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | NCT00079274: 2/1,326 (0.2%) on Cetuximab (serious AE) |
| Pyrexia (fever) | 1,124 | 2.2 2.1–2.3ROR 2.2 · χ² 735 / p 4e-162 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Dehydration | 1,104 | 5.6 5.3–5.9ROR 5.8 · χ² 4,169 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | NCT00079274: 7/1,378 (0.5%) on Cetuximab (serious AE) |
| Infusion related reaction (reaction during infusion) | 1,104 | 11.4 10.8–12.1ROR 11.8 · χ² 10,349 / p <1e-300 | 11.2 EB05 10.7 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 | not reported in cached trials |
| Malignant neoplasm progression | 1,103 | 7.4 6.9–7.8ROR 7.6 · χ² 6,017 / p <1e-300 | 7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | not reported in cached trials |
| Fatigue (tiredness) | 1,076 | 0.9 0.9–1.0ROR 0.9 · χ² 5 / p 0.010 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00079274: 3/1,378 (0.2%) on Cetuximab (serious AE) |
| Death | 1,073 | 0.8 0.8–0.9ROR 0.8 · χ² 35 / p 2e-9 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.6 | NCT00079274: 2/1,326 (0.2%) on Cetuximab (serious AE) |
| Anaemia (low red blood cells) | 926 | 3.3 3.1–3.5ROR 3.3 · χ² 1,469 / p <1e-300 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | not reported in cached trials |
| Hypotension (low blood pressure) | 923 | 3.1 2.9–3.3ROR 3.2 · χ² 1,327 / p 6e-291 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.3 | NCT00079274: 3/1,378 (0.2%) on Cetuximab (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.
- Serous retinal detachment — n=105, PRR 102.4
- Portal venous gas — n=24, PRR 49.1
- Pharyngeal inflammation — n=77, PRR 45.8
- Hypomagnesaemia — n=596, PRR 30.2
- Catheter related infection — n=38, PRR 25.9 (also seen in trial arm)
- Pneumatosis intestinalis — n=81, PRR 19.7
- Blood pressure immeasurable — n=41, PRR 18.4
- Colon cancer metastatic — n=38, PRR 16.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Cetuximab ↔ Hypomagnesaemia.
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 Cetuximab?
In FDA FAERS, the most frequently co-reported reaction terms for Cetuximab are rash, diarrhoea, nausea, vomiting, dyspnoea, neutropenia. 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 Cetuximab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] .
Do FAERS signals prove that Cetuximab 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 8bc6397e-4bd8-4d37-a007-a327e4da34d9, effective 20260416; matched on
openfda.generic_name.exact:"CETUXIMAB") - 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
CETUXIMAB, 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.