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ROFERON A

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Roferon A Adverse Events Reported to the FDA Over Time

How are Roferon A adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Roferon A, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Roferon A is flagged as the suspect drug causing the adverse event.

Most Common Roferon A Adverse Events Reported to the FDA

What are the most common Roferon A adverse events reported to the FDA?

Nausea
32 (2.2%)
Fatigue
25 (1.72%)
Pyrexia
25 (1.72%)
Anaemia
22 (1.51%)
General Physical Health Deteriorati...
20 (1.37%)
Vomiting
20 (1.37%)
Diarrhoea
19 (1.31%)
Hypertension
15 (1.03%)
Dehydration
14 (.96%)
Asthenia
12 (.82%)
Brain Oedema
12 (.82%)
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Headache
12 (.82%)
Ascites
11 (.76%)
Decreased Appetite
11 (.76%)
Dyspnoea
11 (.76%)
Haemoglobin Decreased
11 (.76%)
Hepatic Failure
11 (.76%)
Condition Aggravated
10 (.69%)
Disease Progression
10 (.69%)
Drug Ineffective
10 (.69%)
Influenza Like Illness
10 (.69%)
Cerebral Haemorrhage
9 (.62%)
Depression
9 (.62%)
Neoplasm Malignant
9 (.62%)
Renal Failure Acute
9 (.62%)
Atrial Fibrillation
8 (.55%)
Epistaxis
8 (.55%)
Gastrointestinal Disorder
8 (.55%)
Leukopenia
8 (.55%)
Renal Failure
8 (.55%)
Thrombocytopenia
8 (.55%)
Arrhythmia
7 (.48%)
Cardiac Arrest
7 (.48%)
Cardiac Failure
7 (.48%)
Chills
7 (.48%)
Epilepsy
7 (.48%)
Gastrointestinal Perforation
7 (.48%)
Hypothyroidism
7 (.48%)
Pseudomyxoma Peritonei
7 (.48%)
Blood Alkaline Phosphatase Increase...
6 (.41%)
Blood Sodium Decreased
6 (.41%)
Constipation
6 (.41%)
Haematocrit Decreased
6 (.41%)
Hepatic Cirrhosis
6 (.41%)
Hepatic Steatosis
6 (.41%)
Hepatitis C
6 (.41%)
Hepatosplenomegaly
6 (.41%)
Neutropenia
6 (.41%)
Osteonecrosis
6 (.41%)
Ovarian Neoplasm
6 (.41%)
Pulmonary Fibrosis
6 (.41%)
Respiratory Distress
6 (.41%)
Sexual Abuse
6 (.41%)
Skin Infection
6 (.41%)
Splenomegaly
6 (.41%)
Tinnitus
6 (.41%)
Amnesia
5 (.34%)
Anorexia
5 (.34%)
Arthralgia
5 (.34%)
Bleeding Time Prolonged
5 (.34%)
Blood Creatinine Increased
5 (.34%)
Brain Death
5 (.34%)
Cerebrovascular Disorder
5 (.34%)
Confusional State
5 (.34%)
Diabetes Insipidus
5 (.34%)
Hepatic Enzyme Increased
5 (.34%)
Hepatic Neoplasm Malignant
5 (.34%)
Hypothermia
5 (.34%)
Infection
5 (.34%)
Malaise
5 (.34%)
Pancytopenia
5 (.34%)
Panic Attack
5 (.34%)
Pneumonia
5 (.34%)
Pulmonary Embolism
5 (.34%)
Pulmonary Oedema
5 (.34%)
Pyelocaliectasis
5 (.34%)
Salivary Hypersecretion
5 (.34%)
Tooth Extraction
5 (.34%)
Treatment Noncompliance
5 (.34%)
Tumour Lysis Syndrome
5 (.34%)
Weight Decreased
5 (.34%)
Abdominal Abscess
4 (.27%)
Abdominal Pain
4 (.27%)
Blood Glucose Increased
4 (.27%)
Blood Urea Increased
4 (.27%)
Cerebral Haematoma
4 (.27%)
Completed Suicide
4 (.27%)
Cough
4 (.27%)
Deafness
4 (.27%)
Fluid Retention
4 (.27%)
Haematology Test Abnormal
4 (.27%)
Haematoma
4 (.27%)
Haemolytic Uraemic Syndrome
4 (.27%)
Haemorrhagic Diathesis
4 (.27%)
Hip Surgery
4 (.27%)
Hyperkalaemia
4 (.27%)
Ill-defined Disorder
4 (.27%)
Liver Function Test Abnormal
4 (.27%)
Lymphopenia
4 (.27%)
Myalgia
4 (.27%)
Neoplasm
4 (.27%)

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This graph shows the top adverse events submitted to the FDA for Roferon A, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Roferon A is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Roferon A

What are the most common Roferon A adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Roferon A, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Roferon A is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Roferon A According to Those Reporting Adverse Events

Why are people taking Roferon A, according to those reporting adverse events to the FDA?

Renal Cell Carcinoma
57
Malignant Melanoma
45
Drug Use For Unknown Indication
43
Hepatitis C
37
Renal Cell Carcinoma Stage Unspecif...
35
Metastatic Renal Cell Carcinoma
34
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Chronic Myeloid Leukaemia
13
Renal Cancer
12
Renal Cancer Metastatic
11
Non-hodgkins Lymphoma
10
Product Used For Unknown Indication
8
Chronic Hepatitis
7
Metastatic Malignant Melanoma
6
Lymphoma
6
Plasmacytoma
5
Hepatitis B
5
Myeloproliferative Disorder
5
Mycosis Fungoides
4
Skin Cancer
3
Polycythaemia Vera
3
Macular Degeneration
3
Antiviral Treatment
3
Multiple Sclerosis
3
Benign Hepatic Neoplasm
3
Thrombocythaemia
2
Hodgkins Disease
2
Transplant
2
Hepatic Cirrhosis
2
Kaposis Sarcoma
2
Multiple Myeloma
2
Hepatitis C Virus
2
Desmoid Tumour
2
Essential Thrombocythaemia
2
Hepatitis
2
Polycythaemia
1
Mantle Cell Lymphoma
1
Metastasis
1
Prostate Cancer Metastatic
1
Malignant Melanoma Stage Ii
1
Neuroendocrine Tumour
1
Leukaemia
1
T-cell Lymphoma
1
Choroiditis
1
Malignant Histiocytosis
1
Lung Adenocarcinoma Metastatic
1
Non-hodgkins Lymphoma Stage Iii
1
Behcets Syndrome
1
Hairy Cell Leukaemia
1
Adenocarcinoma
1
Hepatitis Non-a Non-b
1
Vasculitis
1

Roferon A Case Reports

What Roferon A safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Roferon A. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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