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Serostim (Somatropin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Serostim (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 (22)
Death (5)
Life Threatening Events (3)

Reports by Reaction Type

Death (3)Iron Deficiency Anaemia (3)Malformation Venous (3)Carpal Tunnel Syndrome (3)Dieulafoy's Vascular Malformation (3)Respiratory Failure (3)Thrombosis (2)Bone Pain (2)Pain (2)Influenza Like Illness (2)Weight Increased (2)Fatigue (2)

Possible Serostim side effects in male

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

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Chronic Hepatitis, Varices Oesophageal

Adverse event resulted in: death

Drug(s) suspected as cause:
Serostim

Other drugs received by patient: Valtrex; Prevacid; Testosterone Cypionate; Truvada; Pristiq; Truvada; Prezista; Norvir; Concerta; Prinivil; Intelence; Lipitor; Propranolol; Glucophage



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: male

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Serostim

Other drugs received by patient: Unspecified Medication



Possible Serostim side effects in male

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

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Thrombosis, Gout, Atrial Flutter, Bone Pain, Pain, Atrial Fibrillation, Amnesia, Neuropathy Peripheral, Renal Impairment, Fatigue, Peripheral Arterial Occlusive Disease, Cardiac Failure Congestive, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Serostim

Other drugs received by patient: Testosterone; Unspecified Medication; Vitamin B-12



Possible Serostim side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11

Patient: male

Reactions: Brain Injury, Surgery, Cerebrovascular Accident

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: male

Reactions: Death, Polycythaemia, Diarrhoea, Streptococcal Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Serostim
    Indication: HIV Wasting Syndrome
    Start date: 2008-08-12

Serostim
    Start date: 2010-10-11
    End date: 2010-11-02

Other drugs received by patient: Antiviral Medications; Atenolol



Possible Serostim side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: female

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: male

Reactions: Weight Increased, Diabetes Mellitus

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: male

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a physician from United States on 2012-06-08

Patient: male

Reactions: Iron Deficiency Anaemia, Respiratory Failure, Malformation Venous, Carpal Tunnel Syndrome, Dieulafoy's Vascular Malformation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Egrifta
    Indication: Lipodystrophy Acquired
    Start date: 2011-01-01

Serostim
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Other drugs received by patient: Naproxen (Aleve); Aspirin; Epidural; Testim



Possible Serostim side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-08

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Type 2 Diabetes Mellitus

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: male

Reactions: Weight Increased, Basal Cell Carcinoma, T-Lymphocyte Count Increased, Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Serostim
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01
    End date: 2011-01-01

Egrifta
    Start date: 2011-11-01
    End date: 2012-04-01

Egrifta
    Indication: Lipodystrophy Acquired
    Start date: 2011-01-01
    End date: 2011-08-01

Other drugs received by patient: Unspecified Antiretroviral Therapy



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: male

Reactions: Iron Deficiency Anaemia, Respiratory Failure, Malformation Venous, Carpal Tunnel Syndrome, Dieulafoy's Vascular Malformation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Egrifta
    Indication: Lipodystrophy Acquired
    Start date: 2011-01-01

Serostim
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Other drugs received by patient: Naproxen (Aleve); Aspirin; Epidural; Testim



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: male

Reactions: Iron Deficiency Anaemia, Respiratory Failure, Malformation Venous, Carpal Tunnel Syndrome, Dieulafoy's Vascular Malformation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Egrifta
    Indication: Lipodystrophy Acquired
    Start date: 2011-01-01

Serostim
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Other drugs received by patient: Epidural; Naproxen (Aleve); Testim; Aspirin



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-10

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Drug Dose Omission, Thrombosis, Phantom Pain, Pain, Bone Pain, Neuropathy Peripheral, Fatigue, Oedema Peripheral, Cardiac Failure Congestive, Atrial Flutter, Gout, Atrial Fibrillation, Amnesia, Renal Impairment, Peripheral Arterial Occlusive Disease, Memory Impairment, LEG Amputation, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Serostim

Other drugs received by patient: Unspecified Medication; Testosterone; Vitamin B-12



Possible Serostim side effects in male

Reported by a physician from United States on 2011-12-21

Patient: male

Reactions: Macular Hole

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Nasopharyngitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Serostim

Other drugs received by patient: Truvada; Vitamin B-12; Intellience; Iscentress; Testosterone



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-20

Patient: male

Reactions: Dementia, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-29

Patient: male

Reactions: Nephrolithiasis, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Serostim

Other drugs received by patient: Norvir; Truvada; Viramune; Reyataz; Androgel



Possible Serostim side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-14

Patient: male

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a physician from United States on 2011-11-10

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Serostim



Possible Serostim side effects in male

Reported by a physician from United States on 2011-10-11

Patient: male

Reactions: Cholelithiasis, Eye Swelling, Pancreatitis, Cholecystitis

Drug(s) suspected as cause:
Serostim
    Indication: HIV Wasting Syndrome

Serostim

Serostim

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