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Folotyn (Pralatrexate) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 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 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

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 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 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 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 72 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-20

Patient: 72 year old male

Reactions: Joint Swelling, Facial Pain, Erythema

Drug(s) suspected as cause:
Folotyn

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