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Venofer Adverse Events Reported to the FDA Over Time

How are Venofer adverse event reports trending over time?

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

Most Common Venofer Adverse Events Reported to the FDA

What are the most common Venofer adverse events reported to the FDA?

Nausea
70 (2.2%)
Dyspnoea
66 (2.07%)
Infusion Related Reaction
65 (2.04%)
Hypotension
61 (1.91%)
Dizziness
58 (1.82%)
Oedema Peripheral
56 (1.76%)
Vomiting
53 (1.66%)
Anaphylactoid Reaction
42 (1.32%)
Diarrhoea
38 (1.19%)
Paraesthesia
36 (1.13%)
Pyrexia
35 (1.1%)
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Syncope
35 (1.1%)
Hyperhidrosis
34 (1.07%)
Back Pain
31 (.97%)
Abdominal Pain
30 (.94%)
Loss Of Consciousness
30 (.94%)
Chest Pain
29 (.91%)
Arthralgia
28 (.88%)
Burning Sensation
27 (.85%)
Chills
27 (.85%)
Infusion Site Extravasation
26 (.82%)
Thrombophlebitis Superficial
26 (.82%)
Urticaria
26 (.82%)
Drug Exposure During Pregnancy
25 (.78%)
Malaise
25 (.78%)
Pruritus
23 (.72%)
Skin Discolouration
23 (.72%)
Chest Discomfort
21 (.66%)
Erythema
21 (.66%)
Fall
21 (.66%)
Headache
21 (.66%)
Tachycardia
21 (.66%)
Rash
20 (.63%)
Infusion Site Pain
19 (.6%)
Pain In Extremity
19 (.6%)
Blood Pressure Increased
18 (.56%)
Extravasation
18 (.56%)
Phlebitis
18 (.56%)
Cytolytic Hepatitis
17 (.53%)
Hypersensitivity
17 (.53%)
Anaphylactic Reaction
16 (.5%)
Incorrect Drug Administration Rate
15 (.47%)
Joint Swelling
15 (.47%)
Anxiety
14 (.44%)
Confusional State
14 (.44%)
Oxygen Saturation Decreased
14 (.44%)
Pain
14 (.44%)
Pulmonary Embolism
14 (.44%)
Tremor
14 (.44%)
Bradycardia
13 (.41%)
Feeling Hot
13 (.41%)
Anaemia
12 (.38%)
Asthenia
12 (.38%)
Blood Pressure Decreased
12 (.38%)
Cyanosis
12 (.38%)
Feeling Abnormal
12 (.38%)
Flushing
12 (.38%)
Heart Rate Increased
12 (.38%)
Hypertension
12 (.38%)
Muscle Spasms
12 (.38%)
Unresponsive To Stimuli
12 (.38%)
Condition Aggravated
11 (.34%)
Convulsion
11 (.34%)
Infusion Site Discolouration
11 (.34%)
Injection Site Pain
11 (.34%)
Medication Error
11 (.34%)
Somnolence
11 (.34%)
Swelling
11 (.34%)
Thrombophlebitis
11 (.34%)
Disorientation
10 (.31%)
Drug Hypersensitivity
10 (.31%)
Dysgeusia
10 (.31%)
Hypoaesthesia
10 (.31%)
Caesarean Section
9 (.28%)
Cardiac Arrest
9 (.28%)
Fatigue
9 (.28%)
Heart Rate Decreased
9 (.28%)
Injection Site Reaction
9 (.28%)
Overdose
9 (.28%)
Retching
9 (.28%)
Staphylococcal Infection
9 (.28%)
Stillbirth
9 (.28%)
Thrombocytopenia
9 (.28%)
Agitation
8 (.25%)
Blood Glucose Increased
8 (.25%)
C-reactive Protein Increased
8 (.25%)
Central Line Infection
8 (.25%)
Cerebrovascular Accident
8 (.25%)
Chromaturia
8 (.25%)
Cough
8 (.25%)
Gastrointestinal Haemorrhage
8 (.25%)
Infusion Site Swelling
8 (.25%)
Injection Site Thrombosis
8 (.25%)
Musculoskeletal Stiffness
8 (.25%)
Myocardial Infarction
8 (.25%)
Oedema
8 (.25%)
Off Label Use
8 (.25%)
Pallor
8 (.25%)
Sinus Tachycardia
8 (.25%)
Tracheobronchitis
8 (.25%)
Circulatory Collapse
7 (.22%)

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This graph shows the top adverse events submitted to the FDA for Venofer, 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 Venofer 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 Venofer

What are the most common Venofer adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Venofer, 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 Venofer 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 Venofer According to Those Reporting Adverse Events

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

Anaemia
294
Iron Deficiency Anaemia
236
Drug Use For Unknown Indication
164
Product Used For Unknown Indication
112
Iron Deficiency
87
Renal Failure Chronic
41
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Nephrogenic Anaemia
15
Mineral Supplementation
15
Dialysis
11
Anaemia Of Pregnancy
11
Haemoglobin Decreased
9
Haemorrhagic Anaemia
7
Blood Iron Decreased
7
Postpartum Haemorrhage
6
Serum Ferritin Decreased
6
Anaemia Postoperative
6
Malabsorption
6
Crohns Disease
4
Renal Failure
4
Menorrhagia
3
Renal Impairment
3
Microcytic Anaemia
3
Medical Diet
2
Blood Test
2
Polycythaemia
2
Hypochromic Anaemia
2
Blood Erythropoietin Decreased
2
Gastritis Atrophic
2
Diverticulitis
2
Haemodialysis
2
Deficiency Anaemia
2
Anaemia Of Chronic Disease
1
Haemorrhage
1
Prophylaxis
1
Drug Intolerance
1
Unevaluable Event
1
Anaemia Of Malignant Disease
1
Joint Arthroplasty
1
Aplastic Anaemia
1
Erythropoiesis Abnormal
1
Colonoscopy
1
Premedication
1
Haematocrit Decreased
1
Preoperative Care
1
Haemoglobin
1
Bradycardia
1
Thrombocythaemia
1
Syncope
1
Blood Erythropoietin
1
Gastrointestinal Haemorrhage
1
Red Blood Cell Count Decreased
1

Drug Labels

LabelLabelerEffective
VenoferAmerican Regent, Inc.28-SEP-12
VenoferFresenius Medical Care North America28-SEP-12

Venofer Case Reports

What Venofer 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 Venofer. 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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