Drug · FAERS side-effect profile with label screen
Folinate side effects: what 4,739 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Calcium Folinate (Lederle Leucovorin)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,739 reports · 98% serious · 898 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 2Lab value / disease marker 1No label text to screen 37
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 180 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 |
|---|---|---|---|---|---|---|
| Bone marrow failure | 195 | 42.6 37.1–48.9ROR 44.4 · χ² 7,806 / p <1e-300 | 42.0 EB05 37.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.9 · 94% clinician | no trial data cached |
| Neurotoxicity | 99 | 25.3 20.8–30.8ROR 25.9 · χ² 2,280 / p <1e-300 | 25.1 EB05 21.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 98% clinician | no trial data cached |
| Mucosal inflammation | 123 | 21.0 17.6–25.0ROR 21.5 · χ² 2,312 / p <1e-300 | 20.8 EB05 17.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · 93% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 100 | 19.0 15.6–23.1ROR 19.4 · χ² 1,681 / p <1e-300 | 18.9 EB05 15.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 97% clinician | no trial data cached |
| Haematotoxicity | 32 | 15.3 10.8–21.7ROR 15.4 · χ² 413 / p 4e-92 | 15.0 EB05 11.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · 97% clinician | no trial data cached |
| Clostridium difficile colitis | 36 | 15.0 10.9–20.8ROR 15.2 · χ² 457 / p 1e-101 | 14.8 EB05 11.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · ♀ 73% (drug 44%) | no trial data cached |
| Bacterial infection | 59 | 14.1 10.9–18.2ROR 14.3 · χ² 703 / p 3e-155 | 13.9 EB05 11.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Proteinuria | 59 | 13.9 10.8–17.9ROR 14.0 · χ² 691 / p 1e-152 | 13.7 EB05 10.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · 97% clinician | no trial data cached |
| Polyneuropathy | 37 | 13.8 10.0–19.0ROR 13.9 · χ² 426 / p 8e-95 | 13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 100% clinician | no trial data cached |
| Febrile neutropenia | 196 | 13.1 11.4–15.1ROR 13.7 · χ² 2,185 / p <1e-300 | 13.0 EB05 11.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 93% clinician | no trial data cached |
| Neoplasm progression | 95 | 12.0 9.8–14.7ROR 12.2 · χ² 946 / p 4e-208 | 11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · 91% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 365 | 12.0 10.8–13.2ROR 12.9 · χ² 3,665 / p <1e-300 | 11.9 EB05 10.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 93% clinician | no trial data cached |
| Intestinal perforation | 30 | 11.8 8.3–16.9ROR 11.9 · χ² 286 / p 1e-64 | 11.3 EB05 8.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · 93% clinician | no trial data cached |
| Ileus | 30 | 10.8 7.6–15.5ROR 10.9 · χ² 257 / p 4e-58 | 10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 224 | 10.5 9.2–11.9ROR 11.0 · χ² 1,921 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 21 | 9.8 6.4–15.0ROR 9.8 · χ² 157 / p 3e-36 | 8.8 EB05 5.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Neutrophil count decreased | 87 | 9.5 7.7–11.7ROR 9.7 · χ² 655 / p 1e-144 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Thrombocytopenia (low platelets) | 216 | 8.6 7.5–9.8ROR 8.9 · χ² 1,445 / p <1e-300 | 8.5 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 · 95% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 93 | 8.3 6.8–10.1ROR 8.4 · χ² 587 / p 7e-130 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 · 94% clinician | no trial data cached |
| Metastases to liver | 32 | 8.1 5.7–11.4ROR 8.1 · χ² 192 / p 7e-44 | 7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Myelosuppression | 62 | 8.1 6.3–10.3ROR 8.2 · χ² 377 / p 2e-84 | 7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 94% clinician | no trial data cached |
| Hypomagnesaemia | 25 | 8.0 5.4–11.8ROR 8.0 · χ² 146 / p 8e-34 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Intestinal obstruction | 61 | 7.2 5.6–9.3ROR 7.3 · χ² 320 / p 6e-72 | 6.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Mouth ulceration | 34 | 7.2 5.1–10.0ROR 7.2 · χ² 174 / p 5e-40 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Encephalopathy | 39 | 7.1 5.2–9.6ROR 7.1 · χ² 197 / p 6e-45 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · ♀ 66% (drug 44%) · 97% clinician | no trial data cached |
| Metastases to lung | 18 | 6.9 4.4–11.0ROR 6.9 · χ² 85 / p 1e-20 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Device related infection | 24 | 6.9 4.6–10.3ROR 6.9 · χ² 115 / p 4e-27 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Ascites | 45 | 6.8 5.1–9.1ROR 6.8 · χ² 216 / p 4e-49 | 6.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · 95% clinician | no trial data cached |
| Stomatitis (mouth sores) | 91 | 6.6 5.4–8.1ROR 6.8 · χ² 431 / p 4e-96 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 95% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 83 | 6.6 5.3–8.2ROR 6.7 · χ² 389 / p 6e-87 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · ♀ 67% (drug 44%) | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 26 | 6.2 4.2–9.1ROR 6.3 · χ² 109 / p 8e-26 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · 100% clinician | no trial data cached |
| Cytopenia | 16 | 5.9 3.6–9.7ROR 5.9 · χ² 61 / p 3e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 36 | 5.9 4.3–8.2ROR 5.9 · χ² 142 / p 5e-33 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · ♀ 20% (drug 44%) · 94% clinician | no trial data cached |
| Interstitial lung disease | 63 | 5.8 4.5–7.4ROR 5.8 · χ² 244 / p 2e-55 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 13 | 5.8 3.3–9.9ROR 5.8 · χ² 46 / p 5e-12 | 4.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | no trial data cached |
| Viral infection | 43 | 5.7 4.3–7.7ROR 5.8 · χ² 163 / p 1e-37 | 5.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Hepatic encephalopathy | 12 | 5.7 3.2–10.0ROR 5.7 · χ² 42 / p 5e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | no trial data cached |
| Liver injury | 31 | 5.7 4.0–8.1ROR 5.7 · χ² 115 / p 4e-27 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Disease progression | 146 | 5.5 4.7–6.4ROR 5.6 · χ² 533 / p 3e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 92% clinician | no trial data cached |
| Skin reaction | 17 | 5.4 3.3–8.6ROR 5.4 · χ² 56 / p 4e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 469 | 3.2 3.0–3.5ROR 3.5 · χ² 741 / p 2e-163 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 · 92% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 365 | 12.0 10.8–13.2ROR 12.9 · χ² 3,665 / p <1e-300 | 11.9 EB05 10.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 93% clinician | no trial data cached |
| Vomiting | 275 | 2.6 2.3–2.9ROR 2.7 · χ² 274 / p 7e-62 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Pyrexia (fever) | 244 | 3.1 2.8–3.5ROR 3.2 · χ² 355 / p 2e-79 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 · 92% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 224 | 10.5 9.2–11.9ROR 11.0 · χ² 1,921 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Thrombocytopenia (low platelets) | 216 | 8.6 7.5–9.8ROR 8.9 · χ² 1,445 / p <1e-300 | 8.5 EB05 7.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 · 95% clinician | no trial data cached |
| Febrile neutropenia | 196 | 13.1 11.4–15.1ROR 13.7 · χ² 2,185 / p <1e-300 | 13.0 EB05 11.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 93% clinician | no trial data cached |
| Bone marrow failure | 195 | 42.6 37.1–48.9ROR 44.4 · χ² 7,806 / p <1e-300 | 42.0 EB05 37.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.9 · 94% clinician | no trial data cached |
| Anaemia (low red blood cells) | 160 | 3.7 3.2–4.3ROR 3.8 · χ² 317 / p 3e-71 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 · 95% clinician | no trial data cached |
| Hypertension (high blood pressure) | 159 | 3.3 2.8–3.9ROR 3.4 · χ² 258 / p 3e-58 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Abdominal pain | 153 | 2.9 2.5–3.4ROR 3.0 · χ² 192 / p 5e-44 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Disease progression | 146 | 5.5 4.7–6.4ROR 5.6 · χ² 533 / p 3e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 92% clinician | no trial data cached |
| Mucosal inflammation | 123 | 21.0 17.6–25.0ROR 21.5 · χ² 2,312 / p <1e-300 | 20.8 EB05 17.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · 93% clinician | no trial data cached |
| Sepsis (blood infection) | 117 | 4.6 3.9–5.6ROR 4.7 · χ² 332 / p 2e-74 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 · 94% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 102 | 4.7 3.9–5.7ROR 4.8 · χ² 297 / p 6e-67 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Folinate?
In FDA FAERS, the most frequently co-reported reaction terms for Folinate are diarrhoea, neutropenia, vomiting, pyrexia, neuropathy peripheral, thrombocytopenia. 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 Folinate have an FDA boxed warning?
No. The FDA label retrieved for Folinate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Folinate 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 4457d4e3-5942-1a73-e063-6394a90abb24, effective 20251124; matched on
openfda.generic_name.exact:"CALCIUM FOLINATE") - 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, 220 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.