This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Folotyn (Pralatrexate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (37)
Death (8)
Life Threatening Events (5)
Reports by Reaction Type
Febrile Neutropenia (5),
Mucosal Inflammation (5),
Disease Progression (4),
Blister (4),
Platelet Count Increased (3),
Device Related Infection (3),
Abdominal Pain Upper (3),
Acute Respiratory Distress Syndrome (3),
Thrombocytopenia (3),
Stomatitis (3),
Coronavirus Test Positive (3),
Influenza B Virus Test Positive (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Folotyn (Pralatrexate). For a complete list or a specific selection of reports, please use the links above.
Possible Folotyn side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07
Patient: 55 year old male, weighing 84.5 kg (185.9 pounds)
Reactions: Acute Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Folotyn
Dosage: 80 mg/m**2; iv
Indication: Oesophageal Carcinoma
Start date: 2012-04-16
End date: 2012-07-09
Oxaliplatin
Dosage: 65 mg/m**2
Indication: Oesophageal Carcinoma
Start date: 2012-04-16
End date: 2012-07-09
Other drugs received by patient: Prochlorperazine; Lorazepam; Metoclopramide; Leucovorin Calcium; Folic Acid; Albuterol; Cyanocobalamin; Duloxetine Hydrochloride
Possible Folotyn side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient: 55 year old male, weighing 84.5 kg (185.9 pounds)
Reactions: Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Folotyn
Dosage: 80 mg/m**2; ;iv
Indication: Oesophageal Carcinoma
Start date: 2012-04-16
End date: 2012-07-09
Oxaliplatin
Dosage: 65 mg/m**2;
Start date: 2012-04-16
End date: 2012-07-09
Other drugs received by patient: Albuterol; Leucovorin Calcium; Lorazepam; Cyanocobalamin; Duloxetine Hydrochloride; Folic Acid; Prochlorperazine; Metoclopramide; Benadryl / Lidocaine Viscous / Maalox
Possible Folotyn side effects in 53 year old male
Reported by a physician from United States on 2012-06-26
Patient: 53 year old male, weighing 93.4 kg (205.5 pounds)
Reactions: Tumour Lysis Syndrome, Hyperkalaemia, Sepsis, Febrile Neutropenia, Renal Failure Acute, Hyperuricaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Miracle Mouth Wash; Ondansetron; Lortab; Acetaminophen; Morphine; Simethicone; Lorazepam; Colace; Prochlorperazine; Ambien
Possible Folotyn side effects in 51 year old male
Reported by a physician from United States on 2012-06-19
Patient: 51 year old male
Reactions: Pulmonary Embolism, Deep Vein Thrombosis
Drug(s) suspected as cause:
Fluorouracil
Dosage: 3000 mg/m**2;qow
Start date: 2012-02-07
End date: 2012-05-22
Folotyn
Dosage: 148 mg/m**2;qow;iv
Indication: Prostate Cancer
Start date: 2012-02-06
End date: 2012-05-21
Possible Folotyn side effects in 75 year old male
Reported by a physician from United States on 2012-05-21
Patient: 75 year old male
Reactions: Viral Infection, Pneumonitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 34 year old male
Reported by a physician from United States on 2012-05-11
Patient: 34 year old male
Reactions: Metastases To Nervous System, Lymphoma, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 65 year old male
Reported by a physician from Canada on 2012-05-02
Patient: 65 year old male
Reactions: Coronavirus Test Positive, Febrile Neutropenia, Disease Progression, Mucosal Inflammation, Lung Consolidation, Acute Respiratory Distress Syndrome, Lymphoma, Culture Positive, Influenza, Influenza B Virus Test Positive
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Venlafaxine; Acyclovir; Rabeprazole Sodium; Keflex; Levothyroxine Sodium
Possible Folotyn side effects in 82 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20
Patient: 82 year old male, weighing 81.9 kg (180.2 pounds)
Reactions: Stomatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Dosage: 100 mg/m**2; ;iv
Indication: Oesophageal Adenocarcinoma
Start date: 2012-01-23
End date: 2012-02-20
Oxaliplatin
Dosage: 85 mg/m**2; ;iv
Indication: Oesophageal Adenocarcinoma
Start date: 2012-01-23
End date: 2012-02-20
Other drugs received by patient: Folic Acid; Metoprolol Tartrate; Nitroglycerin; Compazine; Aspirin; Glyburide; Simvastatin; Lisinopril
Possible Folotyn side effects in 70 year old female
Reported by a physician from United States on 2012-04-20
Patient: 70 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Splenomegaly, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 43 year old female
Reported by a physician from United States on 2012-04-20
Patient: 43 year old female
Reactions: Stomatitis, Platelet Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 82 year old male
Reported by a physician from United States on 2012-04-09
Patient: 82 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Urinary Tract Infection, Culture Urine Positive, Escherichia Infection, Asthenia, Leukocytosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Dosage: 80 mg/m**2; qow; iv
Indication: Oesophageal Adenocarcinoma
Start date: 2012-01-23
End date: 2012-03-12
Oxaliplatin
Dosage: 65 mg/m**2; qow
Indication: Oesophageal Adenocarcinoma
Start date: 2012-01-23
End date: 2012-03-12
Possible Folotyn side effects in 79 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-03
Patient: 79 year old female
Reactions: Dyspnoea, Chest Pain, Neoplasm Progression, Peripheral T-Cell Lymphoma Unspecified
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Neurontin; Lidocaine; Metoprolol Tartrate; Valtrex; Zolpidem; Zovirax; Diovan; Hydroxyzine; Toviaz
Possible Folotyn side effects in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-04-03
Patient: 34 year old female
Reactions: Aphthous Stomatitis, Drug Dose Omission, Blood Pressure Increased, Lymphadenopathy, Platelet Count Increased, Device Related Infection, Abdominal Pain Upper, Catheter Site Cellulitis, Haemoglobin Decreased, Benign Neoplasm of Thyroid Gland, Blister
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 63 year old male
Reported by a pharmacist from United States on 2012-03-29
Patient: 63 year old male
Reactions: Mucosal Inflammation, Tumour Lysis Syndrome, Renal Failure, Diarrhoea, Clostridial Infection, Thrombocytopenia, Blister, Renal Failure Acute
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Furosemide; Propionate; Salmeterol; Simvastatin; Albuterol; Fluticasone Furoate; Metformin HCL; Terazosin HCL; Montelukast; Potassium; Sitagliptin; Bupropion HCL; Lisinopril; Omeprazole; Dabigatran
Possible Folotyn side effects in 65 year old male
Reported by a physician from Canada on 2012-03-13
Patient: 65 year old male
Reactions: Lung Consolidation, Mucosal Inflammation, Coronavirus Test Positive, Acute Respiratory Distress Syndrome, Febrile Neutropenia, Influenza B Virus Test Positive
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Venlafaxine; Acyclovir; Keflex; Levothyroxine Sodium
Possible Folotyn side effects in 65 year old male
Reported by a physician from Canada on 2012-02-29
Patient: 65 year old male
Reactions: Mucosal Inflammation, Coronavirus Test Positive, Acute Respiratory Distress Syndrome, Febrile Neutropenia, Influenza B Virus Test Positive
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Acyclovir; Keflex
Possible Folotyn side effects in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-02-27
Patient: 34 year old female
Reactions: Cellulitis, Stomatitis, RED Blood Cell Count Decreased, Platelet Count Increased, Device Related Infection, Thyroid Neoplasm, Abdominal Pain Upper, Blister
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-02-14
Patient: 34 year old female
Reactions: Aphthous Stomatitis, Blood Pressure Increased, Drug Dose Omission, Platelet Count Increased, Abdominal Pain Upper, Catheter Site Cellulitis, RED Blood Cell Count Decreased, Blister
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 41 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-07
Patient: 41 year old female, weighing 85.7 kg (188.6 pounds)
Reactions: Staphylococcal Infection, Blood Culture Positive, Proteus Infection, Candidiasis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 55 year old female
Reported by a physician from United States on 2012-01-23
Patient: 55 year old female, weighing 61.2 kg (134.7 pounds)
Reactions: Mucosal Inflammation, Febrile Neutropenia, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Carboplatin
Dosage: 428 mg;qm;iv
Indication: Ovarian Cancer
Start date: 2011-09-14
End date: 2011-10-01
Folotyn
Dosage: 60 mg/m**2;qow;iv
Indication: Ovarian Cancer
Start date: 2011-09-14
End date: 2011-10-01
Other drugs received by patient: Loratadine; Fentanyl; Dexamethasone; Docusate Sodium; Folic Acid; Prochlorperazine; Lactulose; Ondansetron; Motrin; Oxycodone HCL; Bupropion HCL; Sertraline Hydrochloride; Ciprofloxacin; Lorazepam; Methylprednisolone; Xanax
Possible Folotyn side effects in 24 year old female
Reported by a physician from United States on 2012-01-23
Patient: 24 year old female
Reactions: Vomiting
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-23
Patient: 66 year old female
Reactions: Skin Exfoliation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-04
Patient:
Reactions: Cellulitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 51 year old male
Reported by a physician from United States on 2011-12-23
Patient: 51 year old male
Reactions: Weight Decreased, Disease Progression, Pneumonitis, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folotyn
Possible Folotyn side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-13
Patient: 58 year old female, weighing 88.8 kg (195.4 pounds)
Reactions: Dyspepsia, Chest Pain, Presyncope, Platelet Count Decreased, Dizziness, Hyperhidrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Carboplatin
Dosage: qm, iv
Indication: Ovarian Cancer
Start date: 2011-11-25
Folotyn
Dosage: 45 mg/m 2; qow, iv
Indication: Ovarian Cancer
Start date: 2011-11-25
Other drugs received by patient: Ativan; Hydrochlorothiazide; Ondansetron; Vitamin D; Glucosamine Chondroitin; Vitamin D; Omeprazole; Prochlorperazine; Potassiuim Chloride; Calcium; Lisinopril; Dexamethasone
Possible Folotyn side effects in 64 year old female
Reported by a pharmacist from United States on 2011-12-13
Patient: 64 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: Pneumonia, Respiratory Failure
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Folic Acid; Morphine; Allopurinol; Omeprazole
Possible Folotyn side effects in 55 year old female
Reported by a physician from United States on 2011-11-30
Patient: 55 year old female, weighing 92.1 kg (202.6 pounds)
Reactions: General Physical Health Deterioration, Toxic Epidermal Necrolysis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Cyanocobalamin; Ondansetron; Heparin; Folic Acid; Promethazine; Sodium Chloride
Possible Folotyn side effects in 70 year old male
Reported by a physician from United States on 2011-11-08
Patient: 70 year old male
Reactions: Penile Ulceration, Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Folotyn
Other drugs received by patient: Folic Acid; Cyanocobalamin
Possible Folotyn side effects in 61 year old female
Reported by a physician from United States on 2011-10-26
Patient: 61 year old female, weighing 102.5 kg (225.5 pounds)
Reactions: Bacteraemia, Device Related Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fluorouracil
Dosage: 6600 mg; qow; iv
Indication: Colon Cancer Metastatic
Start date: 2010-11-02
Folotyn
Dosage: 165 mg; qow; iv
Indication: Colon Cancer Metastatic
Start date: 2010-11-01
Possible Folotyn side effects in 46 year old male
Reported by a physician from United States on 2011-10-20
Patient: 46 year old male
Reactions: Palmar-Plantar Erythrodysaesthesia Syndrome
Drug(s) suspected as cause:
Folotyn
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