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Saizen (Somatropin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Saizen (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 (251)
Death (2)
Life Threatening Events (6)
Disability (10)

Reports by Reaction Type

Pneumonia (14)Convulsion (13)Headache (11)Suicidal Ideation (10)Fall (9)Vomiting (9)Pyrexia (7)Malaise (7)Angina Pectoris (7)Urinary Tract Infection (7)Injection Site Haematoma (6)Lower Respiratory Tract Infection (6)

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

Possible Saizen side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Sinus Disorder, Attention Deficit / Hyperactivity Disorder

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-27

Patient: male

Reactions: Brain Neoplasm

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in female

Reported by a consumer/non-health professional from Korea, Republic of on 2012-08-27

Patient: female, weighing 35.0 kg (77.0 pounds)

Reactions: Congenital Aplastic Anaemia

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a physician from Ireland on 2012-08-27

Patient: male

Reactions: Respiratory Tract Infection

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Lyrica; Unspecified Oral Steroids



Possible Saizen side effects in 12 year old male

Reported by a consumer/non-health professional from Mexico on 2012-08-27

Patient: 12 year old male

Reactions: Osteochondrosis, Joint Injury, Fall

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-22

Patient: male

Reactions: Lower Limb Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 35.0 kg (77.0 pounds)

Reactions: Excoriation, Ischaemic Cerebral Infarction

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Synthroid



Possible Saizen side effects in male

Reported by a physician from Germany on 2012-08-20

Patient: male, weighing 19.0 kg (41.8 pounds)

Reactions: Pituitary Tumour Benign

Drug(s) suspected as cause:
Saizen
    Indication: Growth Hormone Deficiency
    End date: 2008-01-16

Saizen
    End date: 2008-08-26

Saizen
    End date: 2009-04-08

Saizen
    End date: 2010-10-10

Saizen
    End date: 2011-05-09

Saizen
    End date: 2008-06-26

Other drugs received by patient: Levothyroxine Sodium



Possible Saizen side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Osteochondrosis

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Miralax; Allegra



Possible Saizen side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female, weighing 17.0 kg (37.4 pounds)

Reactions: Systemic Lupus Erythematosus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-14

Patient: male

Reactions: Vomiting, Urinary Tract Infection, Pyrexia

Drug(s) suspected as cause:
Saizen
    Indication: Renal Failure Chronic
    Start date: 2011-05-27

Unspecified Antibiotic
    Indication: Urinary Tract Infection



Possible Saizen side effects in 8 year old female

Reported by a consumer/non-health professional from China on 2012-08-14

Patient: 8 year old female, weighing 17.0 kg (37.4 pounds)

Reactions: Pneumonia

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female, weighing 21.0 kg (46.2 pounds)

Reactions: Asthma, Injection Site Haematoma, Kidney Fibrosis, Urinary Tract Infection, Mesenteric Lymphadenopathy, Decreased Appetite

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Cortef; Dimetapp; Prevacid; Nexium; Multi-Vitamin; Astelin; Nasonex Nasal; Xopenex HFA; Astelin Nasal; Flovent Diskus 100; Flora-Q; Singulair



Possible Saizen side effects in female

Reported by a physician from United States on 2012-08-09

Patient: female, weighing 21.0 kg (46.2 pounds)

Reactions: Asthma, Injection Site Haematoma, Kidney Fibrosis, Urinary Tract Infection, Mesenteric Lymphadenopathy, Decreased Appetite

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Xopenex HFA; Prevacid; Astelin Nasal; Flovent Diskus 100; Multi-Vitamin; Astelin; Dimetapp; Singulair; Nasonex Nasal; Nexium; Cortef; Flora-Q



Possible Saizen side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-09

Patient: female

Reactions: Nasopharyngitis, Vomiting, Increased Upper Airway Secretion, Injection Site Haemorrhage, Injection Site Haematoma, Injection Site Pain, Headache, Eczema, Intracranial Pressure Increased, Sinusitis, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Ventolin; Synthroid; Flovent; Synthroid



Possible Saizen side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-09

Patient: male

Reactions: Vomiting, Urinary Tract Infection, Pyrexia

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a physician from United States on 2012-08-08

Patient: male, weighing 22.0 kg (48.4 pounds)

Reactions: Syncope, Fall, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Unspecified Medications



Possible Saizen side effects in female

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

Patient: female

Reactions: Central Nervous System Lesion

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

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

Patient: male

Reactions: Respiratory Tract Infection

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a physician from United States on 2012-08-02

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Pituitary Tumour Benign, Anger

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a physician from United States on 2012-07-31

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Hemiplegic Migraine, Cerebrovascular Spasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen
    Indication: Growth Hormone Deficiency
    Start date: 2010-12-01

Saizen
    Start date: 2011-02-04

Other drugs received by patient: Pulmicort; Albuterol; Miralax



Possible Saizen side effects in male

Reported by a consumer/non-health professional from Canada on 2012-07-30

Patient: male

Reactions: Surgery

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in female

Reported by a physician from Germany on 2012-07-26

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Hydrocholecystis, Bile Duct Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen
    Indication: Turner's Syndrome

Saizen
    Indication: Dwarfism
    Start date: 2012-04-11



Possible Saizen side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-26

Patient: male

Reactions: Malaise, Hypertension

Drug(s) suspected as cause:
Saizen
    Dosage: 8 mg (24 ui)
    Indication: Growth Hormone Deficiency
    Start date: 2011-10-17
    End date: 2011-10-30

Saizen
    Dosage: 8 mg (24 ui)
    Start date: 2012-02-15
    End date: 2012-02-29



Possible Saizen side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: female

Reactions: Weight Decreased, Tachycardia, Thirst, Poor Quality Sleep, Dyspepsia, Feeling Hot, Onychoclasis, Hair Growth Abnormal, Temperature Intolerance, Tonsillectomy, Livedo Reticularis, Amnesia, Arthralgia, Insomnia, Alopecia, Increased Tendency To Bruise, Asthenia

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Vitamin D; Synthroid; Savella; Melatonin; Multi-Vitamin; Unspecified Steroid Supplement; Prometrium



Possible Saizen side effects in female

Reported by a physician from United States on 2012-07-23

Patient: female, weighing 34.0 kg (74.8 pounds)

Reactions: Petit MAL Epilepsy

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Vyvanase; Oxcarbazepine



Possible Saizen side effects in female

Reported by a physician from United States on 2012-07-20

Patient: female, weighing 83.0 kg (182.6 pounds)

Reactions: Hiatus Hernia

Drug(s) suspected as cause:
Saizen
    Indication: Growth Hormone Deficiency
    Start date: 2010-02-28

Saizen

Other drugs received by patient: Levoxyl; Covaryx; Prilosec; Allegra; Acetylsalicylic Acid SRT; Multi-Vitamin



Possible Saizen side effects in male

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

Patient: male

Reactions: Multiple Hereditary Exostosis

Drug(s) suspected as cause:
Saizen



Possible Saizen side effects in male

Reported by a physician from United States on 2012-07-19

Patient: male, weighing 38.0 kg (83.6 pounds)

Reactions: Obsessive-Compulsive Disorder, TIC, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Vitamin D; Levothyroxine Sodium; Atri-Aloe V; Citalopram Hydrobromide; Multivitamin with Iron; Omega Swirl; Risperidone; Cataplex G; Super EFF; Organix; LY-Zyme Forte; Lorazepam; Organic 15; BIO-GGG-B



Possible Saizen side effects in male

Reported by a physician from United States on 2012-07-18

Patient: male, weighing 23.0 kg (50.6 pounds)

Reactions: Phaeochromocytoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Saizen

Other drugs received by patient: Tenex; Unspecified Blood Pressure Medications; Intuniv

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