Pralatrexate side effects: what 205 FDA adverse event reports show

Pralatrexate · 20 reaction terms · 636 drug–reaction co-reports · data 2026-09-14

Drug class

Folate Analog Metabolic Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

205 reports · 96% serious · 37 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FDA label, Indications and Usage

What it is

Pralatrexate is a dihydrofolate reductase inhibitor. Pralatrexate has the chemical name (2S)-2-[[4-[(1RS)-1-[(2, 4-diaminopteridin-6-yl)methyl]but-3- ynyl]benzoyl]amino]pentanedioic acid.

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 15 strongest signals

Labeled adverse reaction 5Labeled (related wording) 2Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 4

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.
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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Mucosal inflammation	63	78.9 62.4–99.8ROR 87.3 · χ² 4,762 / p <1e-300	76.9 EB05 62.3 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.0	no trial data cached
Stomatitis (mouth sores)	103	55.4 46.4–66.1ROR 65.7 · χ² 5,451 / p <1e-300	54.7 EB05 46.4 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.3	no trial data cached
Blood lactate dehydrogenase increased	20	40.9 26.6–63.0ROR 42.2 · χ² 738 / p 7e-163	39.4 EB05 26.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 4.1	no trial data cached
Malignant neoplasm progression	118	37.8 32.1–44.5ROR 46.0 · χ² 4,202 / p <1e-300	37.5 EB05 32.2 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 16.6 · ♀ 77% (drug 54%)	no trial data cached
Metastases to central nervous system	13	33.1 19.3–56.7ROR 33.7 · χ² 373 / p 2e-83	31.7 EB05 19.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 58.0	no trial data cached
Neutrophil count decreased	41	33.0 24.5–44.4ROR 35.2 · χ² 1,241 / p 4e-272	32.5 EB05 25.0 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.6	no trial data cached
Paralysis	14	31.7 18.9–53.3ROR 32.4 · χ² 387 / p 2e-86	30.5 EB05 19.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 57.5	no trial data cached
Cytopenia	10	27.3 14.7–50.4ROR 27.7 · χ² 227 / p 1e-51	25.9 EB05 14.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.8	no trial data cached
Generalised tonic-clonic seizure	13	25.9 15.1–44.3ROR 26.4 · χ² 287 / p 1e-64	25.0 EB05 15.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 49.3	no trial data cached
Disease progression	69	19.1 15.3–23.8ROR 21.2 · χ² 1,169 / p 2e-256	19.0 EB05 15.5 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 16.3 · 96% clinician	no trial data cached
Febrile neutropenia	38	18.7 13.7–25.4ROR 19.8 · χ² 620 / p 3e-137	18.5 EB05 14.0 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.8	no trial data cached
Platelet count decreased	57	17.4 13.6–22.3ROR 19.0 · χ² 871 / p 1e-191	17.3 EB05 13.8 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.6	no trial data cached
Skin lesion	14	16.8 10.0–28.1ROR 17.1 · χ² 192 / p 6e-44	15.9 EB05 9.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Therapeutic response decreased	21	11.3 7.4–17.3ROR 11.7 · χ² 188 / p 4e-43	10.5 EB05 6.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6	no trial data cached
Myelosuppression	10	9.6 5.2–17.7ROR 9.7 · χ² 69 / p 6e-17	7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4	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
Malignant neoplasm progression	118	37.8 32.1–44.5ROR 46.0 · χ² 4,202 / p <1e-300	37.5 EB05 32.2 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 16.6 · ♀ 77% (drug 54%)	no trial data cached
Stomatitis (mouth sores)	103	55.4 46.4–66.1ROR 65.7 · χ² 5,451 / p <1e-300	54.7 EB05 46.4 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.3	no trial data cached
Disease progression	69	19.1 15.3–23.8ROR 21.2 · χ² 1,169 / p 2e-256	19.0 EB05 15.5 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 16.3 · 96% clinician	no trial data cached
Mucosal inflammation	63	78.9 62.4–99.8ROR 87.3 · χ² 4,762 / p <1e-300	76.9 EB05 62.3 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.0	no trial data cached
Platelet count decreased	57	17.4 13.6–22.3ROR 19.0 · χ² 871 / p 1e-191	17.3 EB05 13.8 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.6	no trial data cached
Neutrophil count decreased	41	33.0 24.5–44.4ROR 35.2 · χ² 1,241 / p 4e-272	32.5 EB05 25.0 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.6	no trial data cached
Febrile neutropenia	38	18.7 13.7–25.4ROR 19.8 · χ² 620 / p 3e-137	18.5 EB05 14.0 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.8	no trial data cached
Therapeutic response decreased	21	11.3 7.4–17.3ROR 11.7 · χ² 188 / p 4e-43	10.5 EB05 6.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6	no trial data cached
Blood lactate dehydrogenase increased	20	40.9 26.6–63.0ROR 42.2 · χ² 738 / p 7e-163	39.4 EB05 26.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 4.1	no trial data cached
Skin lesion	14	16.8 10.0–28.1ROR 17.1 · χ² 192 / p 6e-44	15.9 EB05 9.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Paralysis	14	31.7 18.9–53.3ROR 32.4 · χ² 387 / p 2e-86	30.5 EB05 19.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 57.5	no trial data cached
Generalised tonic-clonic seizure	13	25.9 15.1–44.3ROR 26.4 · χ² 287 / p 1e-64	25.0 EB05 15.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 49.3	no trial data cached
Metastases to central nervous system	13	33.1 19.3–56.7ROR 33.7 · χ² 373 / p 2e-83	31.7 EB05 19.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 58.0	no trial data cached
Myelosuppression	10	9.6 5.2–17.7ROR 9.7 · χ² 69 / p 6e-17	7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4	no trial data cached
Cytopenia	10	27.3 14.7–50.4ROR 27.7 · χ² 227 / p 1e-51	25.9 EB05 14.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.8	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 Pralatrexate?

In FDA FAERS, the most frequently co-reported reaction terms for Pralatrexate are stomatitis, mucosal inflammation, platelet count decreased, neutrophil count decreased, febrile neutropenia, blood lactate dehydrogenase increased. 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 Pralatrexate have an FDA boxed warning?

No. The FDA label retrieved for Pralatrexate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Pralatrexate 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 cc3df863-c51c-49c5-283a-d6808fb49258, effective 20250831; matched on openfda.generic_name.exact:"PRALATREXATE")
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, field patient.drug.openfda.generic_name.exact, 20 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.