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 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 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 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 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 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 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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