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Humatrope (Somatropin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Humatrope (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 (225)
Death (14)
Life Threatening Events (1)
Disability (4)

Reports by Reaction Type

Hospitalisation (29)Drug Dose Omission (17)Malaise (13)Incorrect Dose Administered (10)Cerebrovascular Accident (10)Death (9)Fatigue (9)Vomiting (7)Cushing's Syndrome (7)Cardiac Disorder (6)Pneumonia (6)Pituitary Tumour Recurrent (6)

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

Possible Humatrope side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 70.7 kg (155.4 pounds)

Reactions: Drug Dose Omission, Oesophagitis, Incorrect Dose Administered, Gastroenteritis Viral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope
    Dosage: 0.7 mg, qd
    Start date: 2012-04-26

Humatrope
    Dosage: 0.7 mg, qd
    Indication: Hypopituitarism
    Start date: 2005-01-07
    End date: 2012-04-14

Other drugs received by patient: Vitamin D; Caltrate / 00944201 /; Cortef; Cyanocobalamin



Possible Humatrope side effects in female

Reported by a pharmacist from United States on 2012-08-24

Patient: female

Reactions: Bone Pain, Mood Swings

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Injury, Blister, Staphylococcal Osteomyelitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male, weighing 53.2 kg (117.1 pounds)

Reactions: Carcinoid Tumour Pulmonary, Type 1 Diabetes Mellitus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope

Other drugs received by patient: Novolog



Possible Humatrope side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient:

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Transplant

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

Reported by a consumer/non-health professional from Japan on 2012-08-15

Patient: female

Reactions: Cyclic Vomiting Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope
    Dosage: unk
    Start date: 2012-07-25

Humatrope



Possible Humatrope side effects in female

Reported by a physician from United States on 2012-08-14

Patient: female

Reactions: Off Label Use, Drug Dose Omission, Surgery, Haemorrhage, Rash Macular, Influenza

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-10

Patient: female

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Growth Retardation, Convulsion

Drug(s) suspected as cause:
Humatrope
    Dosage: 1 mg, 6/w
    Indication: Growth Hormone Deficiency
    End date: 2011-11-17

Humatrope
    Dosage: 1 mg, 6/w
    Start date: 2012-07-26



Possible Humatrope side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Fatigue, Swelling, Impaired Gastric Emptying, Ill-Defined Disorder, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Tinnitus, Balance Disorder, Hearing Impaired, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope

Other drugs received by patient: Aspirin; Prozac



Possible Humatrope side effects in 18 month old female

Reported by a physician from South Africa on 2012-08-09

Patient: 18 month old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

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

Patient: female

Reactions: Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

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

Patient: female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope
    Dosage: 0.3 mg, 7x weekly

Humatrope
    Dosage: unk



Possible Humatrope side effects in male

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

Patient: male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

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

Patient: female

Reactions: Tinnitus, Hyperhidrosis, Dysarthria, Syncope, Fatigue, Feeling Hot, Dizziness, Temperature Intolerance

Drug(s) suspected as cause:
Humatrope

Other drugs received by patient: Beta Blocking Agents; Fluoxetine HCL; Levothyroxine Sodium; Gabapentin; Meclizine



Possible Humatrope side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female

Reactions: Hospitalisation, Thyroid Disorder, Immunodeficiency

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in 77 year old female

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

Patient: 77 year old female, weighing 69.8 kg (153.7 pounds)

Reactions: Pituitary Tumour Recurrent

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in 13 year old female

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

Patient: 13 year old female

Reactions: Adenoma Benign, Cushing's Syndrome

Drug(s) suspected as cause:
Humatrope
    Dosage: unk unk, unknown
    Indication: Growth Hormone Deficiency
    Start date: 2011-01-01
    End date: 2011-12-01

Humatrope
    Dosage: unk, unknown
    Start date: 2011-04-01



Possible Humatrope side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Intestinal Haemorrhage, Anaemia

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

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

Patient: female

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in 15 year old female

Reported by a consumer/non-health professional from Hungary on 2012-07-31

Patient: 15 year old female, weighing 53.0 kg (116.6 pounds)

Reactions: Encephalopathy

Drug(s) suspected as cause:
Humatrope

Other drugs received by patient: Estrogen; Haloperidol; Valproate Sodium



Possible Humatrope side effects in 8 year old male

Reported by a physician from South Africa on 2012-07-27

Patient: 8 year old male

Reactions: Viral Upper Respiratory Tract Infection, Upper Respiratory Tract Infection, Headache, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope

Other drugs received by patient: Levothyroxine Sodium; Zolpidem; Tolterodine Tartrate; Gabapentin; Ergocalciferol; Estradiol; Carbamazepine; Hydrocortisone; Morphine Sulfate; Acetaminophen W / Butalbital; Omeprazole; Fluconazole; Venlafaxine; Moxifloxacin; Vitamin B-12; Paroxetine; Albuterol



Possible Humatrope side effects in male

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

Patient: male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in 12 year old male

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

Patient: 12 year old male

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in 16 year old male

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: 16 year old male

Reactions: Wrong Technique in Drug Usage Process, Carcinoid Tumour Pulmonary, Type 1 Diabetes Mellitus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope



Possible Humatrope side effects in 16 year old male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 16 year old male

Reactions: Wrong Technique in Drug Usage Process, Carcinoid Tumour Pulmonary, Type 1 Diabetes Mellitus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humatrope

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