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Pralatrexate Side Effects

The most commonly reported side effects of pralatrexate include malignant neoplasm progression, stomatitis, and disease progression, based on 706 FDA adverse event reports from 2009 to 2025. 5.4% of reports found the drug to be ineffective.

Pralatrexate side effects

Percentages show how often each reaction appears relative to total reports for pralatrexate.

1
Malignant Neoplasm Progression17.4%123
2
Stomatitis14.2%100
3
Disease Progression9.1%64
4
Platelet Count Decreased8.4%59
5
Pyrexia6.8%48
6
Anaemia6.7%47
7
Mucosal Inflammation6.4%45
8
Neutrophil Count Decreased5.9%42
9
Drug Ineffective5.4%38
10
Off Label Use4.7%33
11
Death4.4%31
12
Febrile Neutropenia4.4%31
13
Mucosal Inflammation4.1%29
14
Thrombocytopenia3.8%27
15
Neutropenia3.7%26

These are voluntary reports and do not establish that pralatrexate caused these reactions.

Report severity

92.8%Serious655 reports
42.1%Hospitalizations297 reports
25.1%Fatal177 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pralatrexate drug interactions

Other drugs that appear in adverse event reports alongside pralatrexate. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Cyclophosphamide9.9%70
2
Gemcitabine8.9%63
3
Vincristine-sulfate8.6%61
4
Prednisone7.5%53
5
Romidepsin7.2%51
6
Doxorubicin-hydrochloride6.8%48
7
Etoposide6.5%46
8
Dexamethasone4.8%34
9
Carboplatin3.8%27
10
Methotrexate3.7%26
11
Cytarabine3.1%22
12
Ifosfamide2.4%17
13
Bexarotene2.1%15
14
Vinorelbine-tartrate2.1%15
15
Methylprednisolone1.7%12

Taken alongside

1
Folic-acid24.2%171
2
Cyanocobalamin18.6%131
3
Levoleucovorin7.8%55
4
Ondansetron5.2%37
5
Prednisone5.1%36
6
Dexamethasone4.0%28
7
Acetaminophen3.4%24
8
Omeprazole3.1%22
9
Potassium-chloride3.0%21
10
Acyclovir3.0%21
11
Vincristine-sulfate3.0%21
12
Cyclophosphamide3.0%21
13
Etoposide2.8%20
14
Atorvastatin-calcium2.7%19
15
Doxorubicin-hydrochloride2.5%18

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pralatrexate side effects

39.1% of pralatrexate adverse event reports involve female patients and 53.4% involve male patients. The largest age group is elderly at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.1%
Male53.4%
Unknown7.5%

Age group

< 20.0%
2–110.0%
12–170.9%
18–6447.5%
65+51.6%

What is pralatrexate used for

Conditions and purposes for which patients were taking pralatrexate when the adverse event was reported.

Adenocarcinoma GastricAdjuvant TherapyAdult T-cell Lymphoma/leukaemiaAnaplastic Large Cell Lymphoma T- And Null-cell TypesAnaplastic Large-cell LymphomaAngiocentric LymphomaAngioimmunoblastic T-cell LymphomaAngioimmunoblastic T-cell Lymphoma RecurrentAngioimmunoblastic T-cell Lymphoma Stage IAngioimmunoblastic T-cell Lymphoma Stage IiAngioimmunoblastic T-cell Lymphoma Stage IiiAngioimmunoblastic T-cell Lymphoma Stage IvAdult T-cell Lymphoma/leukaemiaAllogenic Stem Cell TransplantationAnaplastic Large Cell Lymphoma T- And Null-cell Types

Showing 15 of 104 indications

Pralatrexate brand names and reporting trend

Pralatrexate is sold under the brand name Folotyn.

Brand names

Folotyn480

Quarterly reports (20092025)

200920122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pralatrexate with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.