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Norditropin (Somatropin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Norditropin (Somatropin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (123)
Death (4)
Life Threatening Events (12)
Disability (4)

Reports by Reaction Type

Thyroid Cancer (8)Viith Nerve Paralysis (6)Osteochondrosis (6)Headache (5)Sleep Apnoea Syndrome (5)Tonsillar Hypertrophy (4)Neoplasm Progression (4)Oedema Peripheral (4)Condition Aggravated (4)Bone Sarcoma (4)Metastases To Spine (4)Astrocytoma (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Norditropin (Somatropin). For a complete list or a specific selection of reports, please use the links above.

Possible Norditropin side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 71 year old male, weighing 75.3 kg (165.6 pounds)

Reactions: Lung Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Testosterone; Vitamins / 00067501 /; Adderall; Cymbalta



Possible Norditropin side effects in male

Reported by a physician from Japan on 2012-08-16

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Brain Neoplasm

Drug(s) suspected as cause:
Gonadotropin Releasing Hormone (Gnrh)
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-28
    End date: 2011-12-12

Gonal-F RFF PEN
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-28
    End date: 2011-12-12

Norditropin
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-07
    End date: 2011-04-06

Other drugs received by patient: Cortril; Levothyroxine Sodium



Possible Norditropin side effects in 18 year old male

Reported by a physician from Japan on 2012-08-15

Patient: 18 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Optic Nerve Glioma

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 10 year old female

Reported by a physician from Germany on 2012-08-10

Patient: 10 year old female, weighing 32.0 kg (70.4 pounds)

Reactions: Osteochondrosis

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Levothyroxine Sodium; Cortisol / 00014602 /



Possible Norditropin side effects in

Reported by a physician from Ireland on 2012-08-06

Patient:

Reactions: Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 14 year old female

Reported by a consumer/non-health professional from Israel on 2012-08-03

Patient: 14 year old female

Reactions: Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 13 year old male

Reported by a physician from Japan on 2012-08-01

Patient: 13 year old male, weighing 31.0 kg (68.2 pounds)

Reactions: Venous Pressure Increased, Protein-Losing Gastroenteropathy, Diarrhoea, Gastrointestinal Inflammation, Gastrointestinal Oedema, Gastritis Atrophic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Digoxin; Warfarin K; Leuprolide Acetate; Tambocor; Ticlopidine HCL; Enalapril Maleate



Possible Norditropin side effects in 3 year old male

Reported by a physician from Japan on 2012-07-30

Patient: 3 year old male, weighing 12.0 kg (26.4 pounds)

Reactions: Condition Aggravated, Otitis Media

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Warfarin Sodium; Laxoberon; Enalart



Possible Norditropin side effects in 36 year old male

Reported by a physician from Japan on 2012-07-25

Patient: 36 year old male

Reactions: Brain Neoplasm

Drug(s) suspected as cause:
Gonal-F
    Dosage: 150x3/week
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-28
    End date: 2011-12-12

Gonatropin
    Dosage: 3000x3/week
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-28
    End date: 2011-12-12

Norditropin
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-07
    End date: 2011-04-06

Other drugs received by patient: Cortril; Levothyroxine Sodium



Possible Norditropin side effects in 14 year old female

Reported by a physician from France on 2012-07-20

Patient: 14 year old female

Reactions: Thyroid Cancer

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 22 year old female

Reported by a physician from France on 2012-07-20

Patient: 22 year old female

Reactions: Basal Cell Carcinoma

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 8 year old female

Reported by a physician from Serbia on 2012-07-20

Patient: 8 year old female

Reactions: Metastases To Spine, Headache

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in female

Reported by a physician from France on 2012-07-19

Patient: female

Reactions: Thyroid Cancer

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 34 year old male

Reported by a physician from France on 2012-07-19

Patient: 34 year old male

Reactions: Malignant Melanoma

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 31 year old female

Reported by a physician from France on 2012-07-19

Patient: 31 year old female

Reactions: Renal Cancer

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 34 year old male

Reported by a physician from France on 2012-07-19

Patient: 34 year old male

Reactions: Neurilemmoma Benign

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in male

Reported by a physician from France on 2012-07-19

Patient: male

Reactions: Thyroid Cancer

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 19 year old female

Reported by a physician from France on 2012-07-19

Patient: 19 year old female

Reactions: Neurilemmoma Malignant, Thyroid Cancer

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 10 year old male

Reported by a physician from Japan on 2012-07-18

Patient: 10 year old male, weighing 51.0 kg (112.2 pounds)

Reactions: Craniopharyngioma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norditropin
    Dosage: 6.3 mg, qd
    Indication: Growth Hormone Deficiency
    Start date: 2010-10-06

Norditropin
    Dosage: 5.6 mg, qd
    Indication: Body Height Below Normal
    Start date: 2006-11-08
    End date: 2006-11-08

Norditropin
    Dosage: 7.0 mg, qw
    Start date: 2011-08-31

Other drugs received by patient: Desmopressin Acetate; Cortril / 00028601 /; Levothyroxine Sodium



Possible Norditropin side effects in 11 year old female

Reported by a physician from Japan on 2012-07-18

Patient: 11 year old female, weighing 30.0 kg (66.0 pounds)

Reactions: Aplastic Anaemia, Liver Disorder, Influenza

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Clarithromycin



Possible Norditropin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: male, weighing 44.0 kg (96.8 pounds)

Reactions: Neoplasm Recurrence, Metastases To Liver, Malignant Peritoneal Neoplasm

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Norditropin

TEV Tropin 5 MG Vial Teva Pharmaceuticals USA
    Dosage: 1.4 mg daily subcutaneous
    Indication: Growth Hormone Deficiency
    Start date: 2011-05-01
    End date: 2011-10-18

TEV Tropin 5 MG Vial Teva Pharmaceuticals USA
    Dosage: 1.4 mg daily subcutaneous
    Indication: Failure To Thrive
    Start date: 2011-05-01
    End date: 2011-10-18

Other drugs received by patient: Vasotec; Vitamin D



Possible Norditropin side effects in 3 year old male

Reported by a physician from Japan on 2012-07-13

Patient: 3 year old male

Reactions: Otitis Media, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 8 year old female

Reported by a physician from Serbia on 2012-07-13

Patient: 8 year old female, weighing 26.0 kg (57.2 pounds)

Reactions: Metastases To Spine, Headache

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Norditropin
    Dosage: 0.83 mg, qd
    Indication: Hypopituitarism
    Start date: 2008-03-10
    End date: 2009-06-25

Norditropin
    Dosage: 0.66 mg, qd
    Start date: 2011-02-03

Other drugs received by patient: Tiroxin / 00068002 /



Possible Norditropin side effects in 2 year old male

Reported by a physician from Belgium on 2012-07-13

Patient: 2 year old male, weighing 11.0 kg (24.2 pounds)

Reactions: Hypocalcaemia

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Eprex; Calcium Carbonate; Sodium Chloride; Alfacalcidol; D-Cure



Possible Norditropin side effects in 8 year old female

Reported by a physician from Serbia on 2012-07-12

Patient: 8 year old female

Reactions: Metastases To Spine, Headache

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in female

Reported by a physician from Spain on 2012-07-05

Patient: female

Reactions: Ameloblastoma

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 2 year old male

Reported by a physician from Belgium on 2012-07-03

Patient: 2 year old male, weighing 11.0 kg (24.2 pounds)

Reactions: Hypocalcaemia

Drug(s) suspected as cause:
Norditropin

Other drugs received by patient: Eprex; Sodium Chloride; Calcium Carbonate; D-Cure



Possible Norditropin side effects in 8 year old female

Reported by a physician from Serbia on 2012-07-03

Patient: 8 year old female

Reactions: Metastases To Spine, Headache

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Norditropin



Possible Norditropin side effects in 85 year old female

Reported by a physician from Japan on 2012-06-29

Patient: 85 year old female, weighing 53.0 kg (116.6 pounds)

Reactions: Benign Mesenteric Neoplasm, Neoplasm Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope
    Dosage: 0.1 mg, qd
    Indication: Growth Hormone Deficiency
    Start date: 2007-12-21
    End date: 2009-12-21

Norditropin
    Dosage: 0.1 mg, qd
    Indication: Growth Hormone Deficiency
    Start date: 2009-12-21
    End date: 2012-05-03

Norditropin
    Dosage: unk
    Start date: 2012-05-07

Other drugs received by patient: Aldactone; Cortril / 00028601 /; Zolpidem; Levothyroxine Sodium; Diovan; Kary UNI / 00528801 /; Lasix; Loxonin; Meilax; Allopurinol; Sigmart; Rabeprazole Sodium; Risperdal



Possible Norditropin side effects in 13 year old female

Reported by a consumer/non-health professional from France on 2012-06-28

Patient: 13 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Swelling Face, Oedema Peripheral, Fluid Retention

Drug(s) suspected as cause:
Norditropin
    Dosage: unknown

Norditropin
    Dosage: 1.2 mg, qd
    Indication: Growth Hormone Deficiency
    Start date: 2012-01-23
    End date: 2012-02-08

Other drugs received by patient: Hydrocortisone Acetate; Levothyroxine Sodium; Minirin / 00361901 /

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