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Roferon-A (Interferon Alfa-2A) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Roferon-A (Interferon Alfa-2A) 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 (77)
Death (16)
Life Threatening Events (8)
Disability (3)

Reports by Reaction Type

Anaemia (9)Pyrexia (7)Decreased Appetite (7)Diarrhoea (6)Gastrointestinal Perforation (5)Blood Alkaline Phosphatase Increased (5)Vomiting (5)Neoplasm Malignant (5)Leukopenia (5)Completed Suicide (4)Nausea (4)Neutropenia (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Roferon-A (Interferon Alfa-2A). For a complete list or a specific selection of reports, please use the links above.

Possible Roferon-A side effects in male

Reported by a physician from Serbia on 2012-08-22

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Indication: Renal Cell Carcinoma
    Start date: 2009-12-17
    End date: 2010-11-03

Avastin
    Indication: Renal Cell Carcinoma
    Start date: 2009-12-10
    End date: 2010-10-27

Other drugs received by patient: Enalapril Maleate; Iron



Possible Roferon-A side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-16

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Weight Decreased, Hepatitis C, Nausea, Chills, Hypotension, Pyrexia, Depression, Decreased Appetite

Drug(s) suspected as cause:
Roferon-A

Other drugs received by patient: Miosan; Ribavirin



Possible Roferon-A side effects in 35 year old male

Reported by a physician from Portugal on 2012-08-14

Patient: 35 year old male

Reactions: Asthma, Weight Increased, Cholelithiasis, Biliary Colic, NO Therapeutic Response, Hepatic Steatosis

Drug(s) suspected as cause:
Pegasys
    Indication: Hepatitis B

Roferon-A
    Indication: Hepatitis B

Other drugs received by patient: Lamivudine; Adefovir



Possible Roferon-A side effects in female

Reported by a physician from Germany on 2012-08-10

Patient: female, weighing 81.0 kg (178.2 pounds)

Reactions: Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Roferon-A
    Dosage: 3 mio iu
    Indication: Renal Cancer
    Start date: 2012-05-11
    End date: 2012-06-07

Avastin
    Indication: Renal Cancer
    Start date: 2012-05-10
    End date: 2012-06-07



Possible Roferon-A side effects in

Reported by a physician from United States on 2012-08-06

Patient:

Reactions: Weight Decreased, Blood Creatine Phosphokinase Increased, Pyrexia, Cardiac Disorder, Cerebral Haemorrhage, Dyspepsia, DRY Mouth, Blood Creatinine Increased, Blood Alkaline Phosphatase Increased, Stomatitis, Intracranial Tumour Haemorrhage, Anaemia, Aspartate Aminotransferase Increased, Neutropenia, Amylase Increased, Myalgia, Fatigue, Blood Uric Acid Increased, Myocardial Infarction, Thrombocytopenia, Decreased Appetite, Dyspnoea, Vomiting, Nausea, Lymphopenia, Alanine Aminotransferase Increased, Palmar-Plantar Erythrodysaesthesia Syndrome, Rash, Mucosal Inflammation, Hypophosphataemia, Diarrhoea, Respiratory Failure, Arthralgia, Neoplasm Malignant, Ejection Fraction Decreased, Hypothyroidism, Lipase Increased, Hypertension, Asthenia, Leukopenia, Influenza Like Illness

Adverse event resulted in: death

Drug(s) suspected as cause:
Roferon-A
    Dosage: given on nonconsecutive days, 3 mu at three times a week during the first week.
    Indication: Metastatic Renal Cell Carcinoma

Roferon-A
    Dosage: given 6 mu three times a week during second week.

Roferon-A
    Dosage: given 9 mu three times a week thereafter.



Possible Roferon-A side effects in male

Reported by a physician from France on 2012-08-01

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Hyperkalaemia, Anaemia, Lymphopenia, Bacterial Pyelonephritis, Hyponatraemia, Klebsiella Infection, Renal Failure, Gamma-Glutamyltransferase Increased, Cardiac Failure, Posterior Reversible Encephalopathy Syndrome, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Renal Cancer
    Start date: 2011-11-08
    End date: 2011-11-08

Roferon-A
    Indication: Renal Cancer
    Start date: 2011-10-24
    End date: 2011-11-21

Other drugs received by patient: Allopurinol; Candesartan Cilexetil; Previscan (France); Proscar; Temerit



Possible Roferon-A side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Cerebral Infarction

Drug(s) suspected as cause:
Avastin
    Dosage: permanently discontinued on 23 feb 2009.

Roferon-A

Roferon-A
    Dosage: withheld on 17/feb/2009
    Indication: Renal Cell Carcinoma

Avastin
    Dosage: withheld on 17 feb 2009
    Indication: Renal Cell Carcinoma
    Start date: 2008-12-09
    End date: 2009-02-23

Other drugs received by patient: Phospho-Soda; Ferrous Sulfate TAB; Lisinopril; Maalox TC; Glipizide; Omega-3 Triglycerides; Vicodin; Simvastatin



Possible Roferon-A side effects in 66 year old male

Reported by a physician from Germany on 2012-07-20

Patient: 66 year old male

Reactions: Proteinuria, Neutropenia, Pyrexia, Hypertension, Thrombocytopenia, Leukopenia

Drug(s) suspected as cause:
Roferon-A
    Indication: Product Used FOR Unknown Indication

Avastin
    Indication: Renal Cell Carcinoma



Possible Roferon-A side effects in male

Reported by a physician from Belgium on 2012-07-18

Patient: male, weighing 92.0 kg (202.4 pounds)

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: last dose prior to adverse event 17 aug 2012
    Indication: Renal Cell Carcinoma
    Start date: 2010-03-30
    End date: 2010-08-30

Avastin
    Dosage: cyclic
    Start date: 2010-09-28

Roferon-A
    Dosage: dose: 97, form: not provided.
    Indication: Renal Cell Carcinoma

Other drugs received by patient: Tramadol HCL; Nexium; Colchicine; Lipitor; Feldene; Exforge



Possible Roferon-A side effects in male

Reported by a physician from Germany on 2012-07-18

Patient: male, weighing 106.8 kg (235.0 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Pneumonia, Anaemia, Pneumonitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Roferon-A



Possible Roferon-A side effects in male

Reported by a physician from Germany on 2012-07-11

Patient: male, weighing 62.2 kg (136.8 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Hyperbilirubinaemia, Anaemia, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A



Possible Roferon-A side effects in male

Reported by a physician from Hungary on 2012-07-09

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Haemoglobin Decreased, Cardiopulmonary Failure, Asthenia, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Roferon-A
    Dosage: reported as roferon.dose: 3 mu. frequency weekly 3
    Indication: Renal Cell Carcinoma
    Start date: 2008-09-25
    End date: 2008-10-08

Avastin
    Dosage: frequency reported as bi weekly
    Indication: Renal Cell Carcinoma
    Start date: 2008-09-25
    End date: 2008-10-08

Other drugs received by patient: Ensure



Possible Roferon-A side effects in male

Reported by a physician from India on 2012-06-28

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Haemoptysis, Lower Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Dosage: dose: 9 million iu
    Indication: Metastatic Renal Cell Carcinoma

Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-09-10
    End date: 2011-04-07

Other drugs received by patient: Amlodipine



Possible Roferon-A side effects in female

Reported by a consumer/non-health professional from Russian Federation on 2012-06-27

Patient: female

Reactions: Tongue DRY, Monocyte Count Increased, Haemoglobin Decreased, Haematocrit Decreased, RED Blood Cell Count Decreased, Neutrophil Count Decreased, Leukopenia, RED Blood Cell Sedimentation Rate Increased

Drug(s) suspected as cause:
Roferon-A
    Indication: Hepatitis C

Ribavirin
    Administration route: Oral
    Indication: Hepatitis C

Interferon Alfa-2B
    Indication: Hepatitis C



Possible Roferon-A side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-22

Patient: 65 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Vomiting, Psychomotor Retardation, Flatulence, General Physical Health Deterioration, Blood Chloride Increased, Disorientation, Hypernatraemia, Haemoconcentration, Hypercalcaemia, Cachexia, Dehydration, Protein Total Increased, Haemoglobin Increased, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Targretin
    Indication: Mycosis Fungoides
    Start date: 2009-11-01
    End date: 2011-12-05

Emend
    Administration route: Oral
    Indication: Vomiting
    Start date: 2011-09-01

Roferon-A
    Dosage: miu
    Indication: Mycosis Fungoides
    Start date: 2010-11-01

Other drugs received by patient: Nutritional Supplements; Levothyroxine Sodium; Xerial 50; Amitriptyline Hydrochloride; Lexomil



Possible Roferon-A side effects in male

Reported by a individual with unspecified qualification from France on 2012-06-20

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Confusional State, Hypoglycaemia, Amnesia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-03-31
    End date: 2010-01-21

Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-03-31
    End date: 2010-01-18

Other drugs received by patient: Omix; Ginkogink; Imodium; Acetaminophen; Aspirin; Omeprazole; Vitamin D; Lexomil; Glucophage; Dipyridamole; Ezetimibe; Motilium-M



Possible Roferon-A side effects in female

Reported by a physician from Korea, Republic of on 2012-06-18

Patient: female, weighing 50.3 kg (110.7 pounds)

Reactions: Myalgia, Fatigue, Ventricular Tachycardia, Cardiac Arrest, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: Renal Cell Carcinoma
    Start date: 2010-02-23
    End date: 2010-11-05

Roferon-A
    Indication: Renal Cell Carcinoma
    Start date: 2010-02-23
    End date: 2010-11-05



Possible Roferon-A side effects in male

Reported by a physician from Korea, Republic of on 2012-06-18

Patient: male

Reactions: Haemoptysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-09-21
    End date: 2010-05-31

Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-09-21
    End date: 2010-05-31



Possible Roferon-A side effects in female

Reported by a physician from Hong Kong on 2012-06-15

Patient: female, weighing 73.3 kg (161.3 pounds)

Reactions: Drug Ineffective, Anaemia, Metastases To Bone, Disease Progression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-05-20
    End date: 2010-04-05

Roferon-A
    Start date: 2010-05-03
    End date: 2010-05-14

Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-05-20
    End date: 2010-04-05

Avastin
    Start date: 2010-05-03
    End date: 2010-05-14



Possible Roferon-A side effects in male

Reported by a physician from Hong Kong on 2012-06-14

Patient: male, weighing 69.7 kg (153.3 pounds)

Reactions: Abdominal Pain, Renal Cell Carcinoma Recurrent, Vomiting, Intra-Abdominal Haematoma, Anaemia, Neoplasm Progression, Pyrexia, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Start date: 2009-09-09

Roferon-A
    Indication: Renal Cell Carcinoma
    Start date: 2009-06-17
    End date: 2009-06-19

Roferon-A
    Start date: 2009-09-09

Avastin
    Indication: Renal Cell Carcinoma
    Start date: 2009-06-17
    End date: 2009-06-17

Roferon-A
    Start date: 2009-06-29
    End date: 2009-08-12

Avastin
    Start date: 2009-11-25

Other drugs received by patient: Pepcidine; Acetaminophen; Piperacillin; Diclogesic Relax



Possible Roferon-A side effects in male

Reported by a physician from France on 2012-06-14

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Cholelithiasis, Neoplasm Malignant, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Renal Cell Carcinoma
    Start date: 2009-04-27
    End date: 2009-07-08

Roferon-A
    Indication: Renal Cell Carcinoma
    Start date: 2009-04-27
    End date: 2009-06-29



Possible Roferon-A side effects in male

Reported by a physician from Germany on 2012-06-14

Patient: male, weighing 82.0 kg (180.4 pounds)

Reactions: Weight Decreased, Drug Ineffective, Neoplasm Malignant, Anaemia, General Physical Health Deterioration, Anaemia of Malignant Disease, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Avastin
    Start date: 2010-10-11

Roferon-A
    Start date: 2010-09-27

Avastin
    Start date: 2011-01-30

Roferon-A
    Start date: 2010-10-11

Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-08-02
    End date: 2010-09-27

Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-08-02
    End date: 2010-09-27



Possible Roferon-A side effects in male

Reported by a physician from Spain on 2012-06-14

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Vomiting, Diarrhoea, Toxicity To Various Agents, Pyrexia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-01-11
    End date: 2010-03-12

Avastin
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-01-11
    End date: 2010-01-19

Other drugs received by patient: Omeprazole; Tramadol HCL; Nolotil



Possible Roferon-A side effects in male

Reported by a physician from Belgium on 2012-06-14

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-09-24
    End date: 2010-03-26

Avastin
    End date: 2010-04-12

Roferon-A
    Dosage: 6 mui, last dose on 24/may/2010
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-09-24
    End date: 2010-05-24

Other drugs received by patient: Cardizem; Motilium (Belgium); Escitalopram Oxalate; Acetaminophen; Zovirax; Omeprazole



Possible Roferon-A side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-14

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Dosage: 9 miu, qd, last dose on 11-sep-2009
    Indication: Renal Cell Carcinoma
    Start date: 2009-03-25
    End date: 2009-09-11

Avastin
    Dosage: last dose on 11-sep-2009
    Indication: Renal Cell Carcinoma
    Start date: 2009-03-25
    End date: 2009-09-11



Possible Roferon-A side effects in female

Reported by a physician from France on 2012-06-14

Patient: female, weighing 58.0 kg (127.6 pounds)

Reactions: Atelectasis, Posterior Reversible Encephalopathy Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-07-17
    End date: 2010-11-09

Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-10-23
    End date: 2010-11-09

Other drugs received by patient: Keppra; Neurontin; Irbesartan; Morphine Sulfate; Forlax (France); Effexor; Acetaminophen; Duragesic-100; Lovenox



Possible Roferon-A side effects in male

Reported by a physician from France on 2012-06-14

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Cerumen Impaction, Vertigo, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-06-24
    End date: 2010-08-18

Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-06-24
    End date: 2010-08-05

Avastin
    Start date: 2010-09-09
    End date: 2010-09-16

Roferon-A
    End date: 2010-09-16

Other drugs received by patient: Lovenox



Possible Roferon-A side effects in male

Reported by a individual with unspecified qualification from France on 2012-06-13

Patient: male, weighing 94.0 kg (206.8 pounds)

Reactions: Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Roferon-A
    Start date: 2010-01-21

Avastin
    Start date: 2010-01-21

Avastin
    Indication: Renal Cell Carcinoma
    Start date: 2009-03-31
    End date: 2009-08-03

Roferon-A
    Indication: Renal Cell Carcinoma
    Start date: 2009-03-31
    End date: 2009-08-07



Possible Roferon-A side effects in male

Reported by a physician from United Kingdom on 2012-06-13

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Tinnitus, Deafness

Drug(s) suspected as cause:
Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-09-03

Roferon-A
    Dosage: 3 miu
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2009-09-03



Possible Roferon-A side effects in male

Reported by a physician from Belgium on 2012-06-13

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Vascular Pseudoaneurysm, Hypertension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Roferon-A
    Dosage: daily dose: 3 10e6 iu
    Start date: 2011-01-19
    End date: 2011-02-13

Roferon-A
    Dosage: daily dose: 9 10e6 iu
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-09-01
    End date: 2010-11-10

Avastin
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2010-09-01
    End date: 2011-02-16

Roferon-A
    Dosage: daily dose: 6 10e6 iu
    Start date: 2010-11-14
    End date: 2011-01-06

Other drugs received by patient: Tritace; Valsartan

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