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Omnitrope (Somatropin Subcutaneous) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Omnitrope (Somatropin Subcutaneous) 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 (20)

Reports by Reaction Type

Headache (4)Viith Nerve Paralysis (3)Rash (2)Convulsion (2)Syncope (2)Hypersensitivity (1)Haemorrhage (1)Eczema (1)Pyrexia (1)Drug Abuse (1)Papilloedema (1)Hot Flush (1)

Possible Omnitrope side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-23

Patient: male

Reactions: Oropharyngeal Pain, Pyrexia, Prostatic Disorder, Influenza

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient: female, weighing 78.2 kg (171.9 pounds)

Reactions: Hot Flush, Headache

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: female

Reactions: Syncope, Headache

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: female

Reactions: Syncope, Headache

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02

Patient: male, weighing 59.6 kg (131.1 pounds)

Reactions: Unresponsive To Stimuli, Parosmia, Tonic Convulsion, Feeling Abnormal, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope

Other drugs received by patient: Tessalon



Possible Omnitrope side effects in male

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-05-01

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope
    Dosage: 1.2 mg to 1.1 mg
    Indication: Growth Hormone Deficiency
    Start date: 2011-12-21
    End date: 2012-03-05

Omnitrope
    Dosage: 0.02 mg/kg, unk
    Start date: 2012-04-12



Possible Omnitrope side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18

Patient: male, weighing 59.6 kg (131.1 pounds)

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope

Other drugs received by patient: Tessalon



Possible Omnitrope side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-04-18

Patient:

Reactions: Drug Abuse

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in male

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-04-17

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope
    Dosage: 1.2 mg to 1.1 mg
    Indication: Growth Hormone Deficiency
    Start date: 2011-12-21
    End date: 2012-03-05

Omnitrope
    Dosage: 0.02 mg/kg, unk
    Start date: 2012-04-12



Possible Omnitrope side effects in 1 month old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-01

Patient: 1 month old male, weighing 4.0 kg (8.8 pounds)

Reactions: Eczema, Rash

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in male

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-03-19

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in 12 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-12

Patient: 12 year old male, weighing 31.0 kg (68.2 pounds)

Reactions: Oedema Peripheral, Serum Sickness, Erythema Multiforme

Drug(s) suspected as cause:
Omnitrope

Other drugs received by patient: Omnitrope; Daytrana; Keflex



Possible Omnitrope side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-02-17

Patient: female

Reactions: Haemorrhage, Lymphangioma

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-18

Patient: male, weighing 93.0 kg (204.5 pounds)

Reactions: Swelling Face, Cyst

Drug(s) suspected as cause:
Cortef
    Dosage: 70 mg, daily

Genotropin
    Dosage: unk
    Start date: 2010-06-01

Omnitrope
    Dosage: 0.6 mg, daily; 5mg cartridge
    Indication: Hypothalamo-Pituitary Disorder
    Start date: 2011-10-31

Omnitrope
    Indication: Hypopituitarism

Other drugs received by patient: Zolpidem; Flomax; CO-Q-10; Levoxyl; Lisinopril; Probiotics; Aspirin



Possible Omnitrope side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: female

Reactions: Urinary Incontinence, Thirst, Loss of Consciousness

Drug(s) suspected as cause:
Omnitrope

Other drugs received by patient: Dexedrine; Guanfacine Hydrochloride; Clonidine; Depakote; Xyzal; Calcium W / Vitamin D NOS; Prozac; Iron; Lamictal; Melatonin; Nexium



Possible Omnitrope side effects in male

Reported by a physician from Germany on 2011-12-23

Patient: male, weighing 66.0 kg (145.2 pounds)

Reactions: Arthralgia, Bone Marrow Oedema

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in female

Reported by a pharmacist from United States on 2011-12-12

Patient: female, weighing 58.1 kg (127.7 pounds)

Reactions: Urticaria, Rash

Drug(s) suspected as cause:
Omnitrope
    Dosage: 0.1mg daily subcutaneously
    Indication: Dwarfism
    Start date: 2011-11-16
    End date: 2011-11-18

Omnitrope
    Dosage: 0.1mg daily subcutaneously
    Indication: Hypothalamo-Pituitary Disorder
    Start date: 2011-11-16
    End date: 2011-11-18

Other drugs received by patient: Fenofibrate; Synthroid



Possible Omnitrope side effects in male

Reported by a physician from France on 2011-11-04

Patient: male

Reactions: Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in male

Reported by a physician from United States on 2011-11-02

Patient: male, weighing 47.2 kg (103.8 pounds)

Reactions: Cerebellar Infarction, Benign Intracranial Hypertension, Musculoskeletal Stiffness, Headache, Cerebrovascular Accident, Papilloedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnitrope



Possible Omnitrope side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-25

Patient: female, weighing 72.6 kg (159.6 pounds)

Reactions: Hypersensitivity, Hormone Level Abnormal

Drug(s) suspected as cause:
Genotropin
    Dosage: 0.4 mg, unk
    Indication: Dwarfism
    Start date: 2011-10-15

Humatrope
    Dosage: 0.2 mg, unk
    Indication: Dwarfism

Omnitrope
    Dosage: 0.2 mg, unk
    Indication: Dwarfism
    Start date: 2011-05-01
    End date: 2011-01-01

Other drugs received by patient: Thyroid TAB

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