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GENOTROPIN

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Genotropin Adverse Events Reported to the FDA Over Time

How are Genotropin adverse event reports trending over time?

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

Most Common Genotropin Adverse Events Reported to the FDA

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

Headache
248 (3.5%)
Neoplasm Recurrence
159 (2.24%)
Death
119 (1.68%)
Arthralgia
99 (1.4%)
Vomiting
97 (1.37%)
Nausea
89 (1.26%)
Fatigue
85 (1.2%)
Injection Site Pain
85 (1.2%)
Drug Ineffective
76 (1.07%)
Condition Aggravated
67 (.95%)
Craniopharyngioma
66 (.93%)
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Weight Increased
66 (.93%)
Pain In Extremity
65 (.92%)
Oedema Peripheral
61 (.86%)
Pituitary Tumour Benign
60 (.85%)
Pyrexia
58 (.82%)
Convulsion
53 (.75%)
Weight Decreased
52 (.73%)
Rash
50 (.71%)
Dizziness
49 (.69%)
Injection Site Haemorrhage
48 (.68%)
Incorrect Dose Administered
47 (.66%)
Malaise
46 (.65%)
Pneumonia
43 (.61%)
Sleep Apnoea Syndrome
43 (.61%)
Hypertension
40 (.56%)
Brain Neoplasm
39 (.55%)
Pain
39 (.55%)
Tremor
38 (.54%)
Abdominal Pain
37 (.52%)
Incorrect Route Of Drug Administrat...
33 (.47%)
Insomnia
33 (.47%)
Circumstance Or Information Capable...
31 (.44%)
Depression
29 (.41%)
Hypersensitivity
29 (.41%)
Diarrhoea
28 (.4%)
Osteochondrosis
28 (.4%)
Poor Quality Drug Administered
28 (.4%)
Scoliosis
28 (.4%)
Abnormal Behaviour
27 (.38%)
Asthenia
27 (.38%)
Intracranial Pressure Increased
27 (.38%)
Papilloedema
27 (.38%)
Cough
26 (.37%)
Dyspnoea
26 (.37%)
Injection Site Haematoma
26 (.37%)
Overdose
25 (.35%)
Blood Glucose Increased
24 (.34%)
Epilepsy
24 (.34%)
Aggression
23 (.32%)
Feeling Abnormal
22 (.31%)
Mood Altered
22 (.31%)
Myalgia
22 (.31%)
Nephrotic Syndrome
22 (.31%)
Astrocytoma
21 (.3%)
Pruritus
21 (.3%)
Sinusitis
21 (.3%)
Swelling
21 (.3%)
Urticaria
21 (.3%)
Abdominal Pain Upper
20 (.28%)
Gait Disturbance
20 (.28%)
Joint Swelling
20 (.28%)
Neoplasm Progression
20 (.28%)
Pancreatitis Acute
20 (.28%)
Pituitary Tumour Recurrent
19 (.27%)
Discomfort
18 (.25%)
Fall
18 (.25%)
Fluid Retention
18 (.25%)
Malignant Melanoma
18 (.25%)
Somnolence
18 (.25%)
Carpal Tunnel Syndrome
17 (.24%)
Febrile Convulsion
17 (.24%)
Loss Of Consciousness
17 (.24%)
Migraine
17 (.24%)
Oedema
17 (.24%)
Swelling Face
17 (.24%)
Alopecia
16 (.23%)
Anxiety
16 (.23%)
Back Pain
16 (.23%)
Blood Pressure Increased
16 (.23%)
Glucose Tolerance Impaired
16 (.23%)
Irritability
16 (.23%)
Palpitations
16 (.23%)
Alanine Aminotransferase Increased
15 (.21%)
Arthropathy
15 (.21%)
Burning Sensation
15 (.21%)
Decreased Appetite
15 (.21%)
Muscular Weakness
15 (.21%)
Paraesthesia
15 (.21%)
Prostate Cancer
15 (.21%)
Tonsillar Hypertrophy
15 (.21%)
Erythema
14 (.2%)
Haematuria
14 (.2%)
Injection Site Reaction
14 (.2%)
Meningioma
14 (.2%)
Abdominal Distension
13 (.18%)
Asthma
13 (.18%)
Blindness
13 (.18%)
Chills
13 (.18%)
Infectious Mononucleosis
13 (.18%)
Pituitary Tumour
13 (.18%)

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

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

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

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

Hypopituitarism
833
Growth Hormone Deficiency
682
Body Height Below Normal
221
Prader-willi Syndrome
118
Turners Syndrome
94
Dwarfism
87
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Growth Retardation
78
Ill-defined Disorder
65
Small For Dates Baby
60
Off Label Use
53
Renal Failure Chronic
36
Blood Growth Hormone Decreased
27
Foetal Growth Retardation
22
Blood Growth Hormone
21
Hypothalamo-pituitary Disorder
15
Drug Use For Unknown Indication
9
Silver-russell Syndrome
8
Multiple Sclerosis
6
Empty Sella Syndrome
6
Blood Growth Hormone Abnormal
6
Hypothyroidism
6
Product Used For Unknown Indication
6
Insulin-like Growth Factor Decrease...
5
Failure To Thrive
5
Blood Glucose Increased
4
Crohns Disease
4
Hormone Replacement Therapy
4
Metabolic Disorder
4
Noonan Syndrome
4
Malnutrition
3
Osteoporosis
3
Pituitary Tumour
3
Precocious Puberty
3
Septo-optic Dysplasia
2
Cystinuria
2
Hypotonia
2
Immune Reconstitution Syndrome
2
Bone Disorder
2
Diabetes Mellitus
2
Underweight
2
Overweight
2
Hiv Wasting Syndrome
2
Ovarian Failure
2
Cystic Fibrosis
2
Drug Administration Error
2
Complex Regional Pain Syndrome
2
Adrenogenital Syndrome
2
Chronic Fatigue Syndrome
2
Hormone Therapy
2
Asthenia
2
Adjuvant Therapy
2

Drug Labels

LabelLabelerEffective
GenotropinPharmacia and Upjohn Company31-MAR-11
GenotropinPhysicians Total Care, Inc.08-APR-11

Genotropin Case Reports

What Genotropin 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 Genotropin. 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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