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INCRELEX

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Increlex Adverse Events Reported to the FDA Over Time

How are Increlex adverse event reports trending over time?

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

Most Common Increlex Adverse Events Reported to the FDA

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

Headache
36 (3.19%)
Hypoglycaemia
32 (2.83%)
Injection Site Erythema
24 (2.13%)
Injection Site Urticaria
24 (2.13%)
Injection Site Pruritus
23 (2.04%)
Urticaria
22 (1.95%)
Vomiting
20 (1.77%)
Intracranial Pressure Increased
15 (1.33%)
Papilloedema
15 (1.33%)
Condition Aggravated
14 (1.24%)
Convulsion
13 (1.15%)
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Tonsillar Hypertrophy
12 (1.06%)
Abdominal Pain
11 (.97%)
Dyspnoea
11 (.97%)
Hypersensitivity
11 (.97%)
Nausea
11 (.97%)
Hepatic Cirrhosis
10 (.89%)
Aggression
9 (.8%)
Anaemia
9 (.8%)
Benign Intracranial Hypertension
9 (.8%)
Dizziness
9 (.8%)
Injection Site Pain
9 (.8%)
Rash
9 (.8%)
Abdominal Distension
8 (.71%)
Alopecia
8 (.71%)
Constipation
8 (.71%)
Diplopia
8 (.71%)
Injection Site Induration
8 (.71%)
Injection Site Swelling
8 (.71%)
Loss Of Consciousness
8 (.71%)
Blood Glucose Increased
7 (.62%)
Drug Dose Omission
7 (.62%)
Eyelid Oedema
7 (.62%)
Pyrexia
7 (.62%)
Somnolence
7 (.62%)
Swelling Face
7 (.62%)
Vision Blurred
7 (.62%)
Adenoidal Hypertrophy
6 (.53%)
Gastroenteritis
6 (.53%)
Hair Texture Abnormal
6 (.53%)
Hyperglycaemia
6 (.53%)
Oedema Peripheral
6 (.53%)
Pruritus
6 (.53%)
Acute Respiratory Distress Syndrome
5 (.44%)
Angioedema
5 (.44%)
Asthenia
5 (.44%)
Ear Infection
5 (.44%)
Eye Swelling
5 (.44%)
Fatigue
5 (.44%)
Febrile Convulsion
5 (.44%)
Haemoglobin Decreased
5 (.44%)
Hydrocele
5 (.44%)
Iga Nephropathy
5 (.44%)
Injection Site Warmth
5 (.44%)
Nasal Congestion
5 (.44%)
Nasopharyngitis
5 (.44%)
Neck Pain
5 (.44%)
Pharyngitis Streptococcal
5 (.44%)
Swelling
5 (.44%)
Toxoplasmosis
5 (.44%)
Breath Odour
4 (.35%)
Bronchitis
4 (.35%)
Cardiac Ventricular Disorder
4 (.35%)
Culture Urine Positive
4 (.35%)
Cyanosis
4 (.35%)
Dehydration
4 (.35%)
Depression
4 (.35%)
Diarrhoea
4 (.35%)
Drug Hypersensitivity
4 (.35%)
Erythema
4 (.35%)
Haematuria
4 (.35%)
Hepatomegaly
4 (.35%)
Inflammation
4 (.35%)
Injection Site Haematoma
4 (.35%)
Lip Swelling
4 (.35%)
Lung Disorder
4 (.35%)
Malnutrition
4 (.35%)
Migraine
4 (.35%)
Off Label Use
4 (.35%)
Ovarian Adenoma
4 (.35%)
Ovarian Granulosa-theca Cell Tumour
4 (.35%)
Ovarian Torsion
4 (.35%)
Pneumonia
4 (.35%)
Portal Hypertension
4 (.35%)
Respiratory Distress
4 (.35%)
Retinopathy Proliferative
4 (.35%)
Snoring
4 (.35%)
Splenomegaly
4 (.35%)
Strabismus
4 (.35%)
Thyroid Neoplasm
4 (.35%)
Abnormal Behaviour
3 (.27%)
Anaphylactic Reaction
3 (.27%)
Back Pain
3 (.27%)
Beta Haemolytic Streptococcal Infec...
3 (.27%)
Blood Ketone Body Present
3 (.27%)
Blood Potassium Decreased
3 (.27%)
Body Mass Index Increased
3 (.27%)
Cerebral Atrophy
3 (.27%)
Chest Pain
3 (.27%)
Clonus
3 (.27%)
Cough
3 (.27%)

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

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

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

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

Insulin-like Growth Factor Decrease...
105
Body Height Below Normal
58
Growth Hormone Deficiency
44
Product Used For Unknown Indication
24
Growth Retardation
22
Primary Insulin Like Growth Factor-...
11
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Failure To Thrive
10
Retts Disorder
9
Off Label Use
8
Foetal Growth Restriction
7
Blood Growth Hormone Abnormal
7
Drug Use For Unknown Indication
6
Insulin-like Growth Factor Increase...
5
Insulin Resistance Syndrome
5
Autosomal Chromosome Anomaly
4
Dwarfism
4
Hypopituitarism
3
Insulin-like Growth Factor
2
Chondrodystrophy
2
Congenital Osteodystrophy
2
Ill-defined Disorder
1
Prader-willi Syndrome
1
Antibody Test Abnormal
1
Insulin Resistance
1
Crohns Disease
1
Hiv Infection
1
Hormone Replacement Therapy
1
Antibody Test Positive
1
Impaired Fasting Glucose
1
Amyotrophic Lateral Sclerosis
1
Immunodeficiency
1
Convulsion
1
Noonan Syndrome
1

Drug Labels

LabelLabelerEffective
IncrelexIpsen Biopharmaceuticals, Inc.01-SEP-12

Increlex Case Reports

What Increlex 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 Increlex. 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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