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FERRLECIT

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Ferrlecit Adverse Events Reported to the FDA Over Time

How are Ferrlecit adverse event reports trending over time?

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

Most Common Ferrlecit Adverse Events Reported to the FDA

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

Nausea
93 (4%)
Hypotension
87 (3.75%)
Vomiting
82 (3.53%)
Dyspnoea
78 (3.36%)
Infusion Related Reaction
53 (2.28%)
Abdominal Pain
49 (2.11%)
Blood Pressure Decreased
47 (2.02%)
Dizziness
46 (1.98%)
Diarrhoea
44 (1.89%)
Back Pain
38 (1.64%)
Loss Of Consciousness
38 (1.64%)
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Hyperhidrosis
34 (1.46%)
Faecal Incontinence
33 (1.42%)
Anaphylactic Reaction
31 (1.33%)
Asthenia
31 (1.33%)
Chest Pain
30 (1.29%)
Syncope
29 (1.25%)
Oedema Peripheral
27 (1.16%)
Urticaria
26 (1.12%)
Headache
23 (.99%)
Arthralgia
22 (.95%)
Hypoaesthesia
22 (.95%)
Malaise
21 (.9%)
Burning Sensation
20 (.86%)
Chest Discomfort
20 (.86%)
Paraesthesia
20 (.86%)
Heart Rate Decreased
18 (.77%)
Pain In Extremity
18 (.77%)
Hypersensitivity
17 (.73%)
Urinary Incontinence
16 (.69%)
Feeling Abnormal
15 (.65%)
Fatigue
14 (.6%)
Rash
14 (.6%)
Erythema
13 (.56%)
Pallor
13 (.56%)
Swollen Tongue
13 (.56%)
Unresponsive To Stimuli
13 (.56%)
Bradycardia
12 (.52%)
Chills
12 (.52%)
Flushing
12 (.52%)
Muscle Spasms
12 (.52%)
Pruritus
12 (.52%)
Swelling Face
12 (.52%)
Tachycardia
12 (.52%)
Hypotonia
11 (.47%)
Product Quality Issue
11 (.47%)
Pyrexia
11 (.47%)
Respiratory Distress
11 (.47%)
Anaphylactoid Reaction
10 (.43%)
Blood Pressure Systolic Decreased
10 (.43%)
Confusional State
10 (.43%)
Convulsion
10 (.43%)
Drug Exposure During Pregnancy
10 (.43%)
Heart Rate Increased
10 (.43%)
Oxygen Saturation Decreased
10 (.43%)
Blood Pressure Increased
9 (.39%)
Death
9 (.39%)
Injection Site Swelling
9 (.39%)
Pain
9 (.39%)
Tremor
9 (.39%)
Cardiac Arrest
8 (.34%)
Cold Sweat
8 (.34%)
Dysstasia
8 (.34%)
Haematocrit Decreased
8 (.34%)
Joint Swelling
8 (.34%)
Throat Tightness
8 (.34%)
Cardio-respiratory Arrest
7 (.3%)
Cyanosis
7 (.3%)
Discomfort
7 (.3%)
Disorientation
7 (.3%)
Hypertension
7 (.3%)
Hypokalaemia
7 (.3%)
Hypoxia
7 (.3%)
Infusion Site Rash
7 (.3%)
Overdose
7 (.3%)
Retching
7 (.3%)
Anaphylactic Shock
6 (.26%)
Blood Pressure Systolic Increased
6 (.26%)
Dry Mouth
6 (.26%)
Dysgeusia
6 (.26%)
Dyskinesia
6 (.26%)
Fall
6 (.26%)
Infusion Site Urticaria
6 (.26%)
Injection Site Pain
6 (.26%)
Injection Site Reaction
6 (.26%)
Meningitis
6 (.26%)
Meningitis Enteroviral
6 (.26%)
Respiratory Arrest
6 (.26%)
Shock
6 (.26%)
Vision Blurred
6 (.26%)
Abdominal Discomfort
5 (.22%)
Agitation
5 (.22%)
Anxiety
5 (.22%)
Decreased Appetite
5 (.22%)
Dysphonia
5 (.22%)
Eye Rolling
5 (.22%)
Eye Swelling
5 (.22%)
Haemoglobin Decreased
5 (.22%)
Lip Swelling
5 (.22%)
Medication Error
5 (.22%)
Pulse Absent
5 (.22%)

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

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

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

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

Iron Deficiency Anaemia
157
Product Used For Unknown Indication
155
Anaemia
103
Drug Use For Unknown Indication
60
Iron Deficiency
53
Nephrogenic Anaemia
10
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Mineral Supplementation
6
Renal Failure Chronic
6
Blood Iron Decreased
5
Renal Disorder
4
Malabsorption
3
Haemoglobin Decreased
3
Anaemia Of Chronic Disease
2
Dialysis
2
Drug Intolerance
2
Menorrhagia
2
Thalassaemia
2
Renal Failure
1
Foetal Exposure During Pregnancy
1
Renal Impairment
1
Asthenia
1
Gastrointestinal Haemorrhage
1
Endoscopy Upper Gastrointestinal Tr...
1
Haemodialysis
1
Thrombocythaemia
1
Vitamin Supplementation
1
Restless Legs Syndrome
1
Gastric Bypass
1
Therapeutic Procedure
1
Pernicious Anaemia
1
Vomiting In Pregnancy
1
Microcytic Anaemia
1
Blood Iron
1
Serum Ferritin Decreased
1
Fatigue
1
Renal Transplant
1

Drug Labels

LabelLabelerEffective
Ferrlecitsanofi-aventis U.S. LLC31-AUG-11

Ferrlecit Case Reports

What Ferrlecit 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 Ferrlecit. 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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