What the label lists and what reports show
Pralatrexate side effects
Pralatrexate's FDA label: “Most common adverse reactions (>35%) are mucositis, thrombocytopenia, nausea, and fatigue.” FAERS holds 205 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is malignant neoplasm progression (27 reports).
- Generic listed
Check it at the source: the pralatrexate FDA label on DailyMed (effective November 15, 2022, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Pralatrexate injection?Pralatrexate injection may cause serious side effects, including: Low blood cell counts: Your healthcare provider will do blood tests to check your blood cell counts before and during treatment with Pralatrexate injection. Tell your healthcare provider right away if you develop any signs of infection, fever, bleeding or tiredness during treatment with Pralatrexate injection. Redness and sores of the mucous membrane lining of the mouth, lips,throat, digestive tract, and genitals (mucositis). Mucositis is common with Pralatrexate injection and can be severe. Tell your healthcare provider if you develop redness or painful sores in your mouth or throat, or have trouble speaking, eating or drinking. Your healthcare provider will tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and help control the discomfort from mucositis. Severe skin reactions. […]
Source: FDA drug label, NDA022468 (Acrotech Biopharma), as published by Fresenius Kabi USA, LLC, effective November 15, 2022 (SPL set a5daa583-4965-4564-ad87-41ffe6c08a11), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>35%) are mucositis, thrombocytopenia, nausea, and fatigue.
Table 4 Adverse Reactions in (≥ 10%) in Patients Who Received Pralatrexate Injection in Study PDX-008
| Reaction | All Grades (%) | Grade 3 (%) | Grade 4 (%) |
|---|---|---|---|
| Any Adverse Reaction | 100 | 43 | 31 |
| Mucositis a | 70 | 17 | 4 |
| Thrombocytopenia b | 41 | 14 | 19 b |
| Nausea | 40 | 4 | 0 |
| Fatigue | 36 | 5 | 2 |
| Anemia | 34 | 15 | 2 |
| Constipation | 33 | 0 | 0 |
| Pyrexia | 32 | 1 | 1 |
| Edema | 30 | 1 | 0 |
| Cough | 28 | 1 | 0 |
| Epistaxis | 26 | 0 | 0 |
| Vomiting | 25 | 2 | 0 |
| Neutropenia | 24 | 13 | 7 |
| Diarrhea | 21 | 2 | 0 |
| Dyspnea | 19 | 7 | 0 |
| Anorexia | 15 | 3 | 0 |
| Hypokalemia | 15 | 4 | 1 |
| Rash | 15 | 0 | 0 |
| Pruritus | 14 | 2 | 0 |
| Pharyngolaryngeal pain | 14 | 1 | 0 |
| Liver function test abnormal c | 13 | 5 | 0 |
| Abdominal pain | 12 | 4 | 0 |
| Pain in extremity | 12 | 0 | 0 |
| Back pain | 11 | 3 | 0 |
| Leukopenia | 11 | 3 | 4 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Mucositis [see Warnings and Precautions ( 5.2 )] Dermatologic Reactions [see Warnings and Precautions ( 5.3 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] Hepatic Toxicity [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (>35%) are mucositis, thrombocytopenia, nausea, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Peripheral T-cell Lymphoma The safety of Pralatrexate injection was evaluated in Study PDX-008 [see Clinical Studies ( 14 )]. Patients received Pralatrexate injection 30 mg/m 2 once weekly for 6 weeks in 7-week cycles. The median duration of treatment was 70 days (range: 1 day to 1.5 years). The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment. Overall, 85% of scheduled doses were administered. …
Source: FDA drug label, NDA022468 (Acrotech Biopharma), as published by Fresenius Kabi USA, LLC, effective November 15, 2022 (SPL set a5daa583-4965-4564-ad87-41ffe6c08a11), via openFDA; the full label on DailyMed
What do FAERS reports show?
205 reports list pralatrexate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 37 are coded as a death and 83 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pralatrexate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions