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Somavert (Pegvisomant) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Somavert (Pegvisomant) 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 (86)
Death (3)
Disability (2)

Reports by Reaction Type

Rash (10)Pruritus (8)Weight Increased (8)Blood Growth Hormone Increased (7)Urticaria (7)Drug Ineffective (6)Hepatitis (6)Fatigue (6)Depression (6)Hypersensitivity (5)Injection Site Erythema (5)Back Pain (5)

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

Possible Somavert side effects in 39 year old male

Reported by a consumer/non-health professional from Argentina on 2012-08-21

Patient: 39 year old male

Reactions: Encephalitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Hidrocortizon; T4; Nebido



Possible Somavert side effects in 75 year old female

Reported by a consumer/non-health professional from Argentina on 2012-08-21

Patient: 75 year old female

Reactions: Colitis, Abdominal Distension, Liver Disorder, Eructation

Drug(s) suspected as cause:
Somavert
    Dosage: 15 mg, 1x/day
    Start date: 2012-07-01

Somavert
    Dosage: 10 mg, 1x/day
    Indication: Acromegaly
    Start date: 2012-03-01

Other drugs received by patient: Diuret; Levothyroxine; Carvedilol; Lotrial; Vasotenal ^pharma Investi^



Possible Somavert side effects in 61 year old female

Reported by a consumer/non-health professional from Argentina on 2012-08-21

Patient: 61 year old female

Reactions: Lung Neoplasm

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Lotrial; Omeprazole



Possible Somavert side effects in 41 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 41 year old female

Reactions: Nausea

Drug(s) suspected as cause:
Somavert
    Dosage: 30 mg, 1x/day
    Indication: Acromegaly

Somavert
    Indication: Gigantism



Possible Somavert side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 61 year old female, weighing 116.0 kg (255.2 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Lung Neoplasm

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in 13 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 13 year old male

Reactions: Hepatic Enzyme Increased

Drug(s) suspected as cause:
Somavert
    Dosage: unk
    Indication: Acromegaly
    Start date: 2012-05-01

Somavert
    Dosage: 10 mg, daily
    Indication: Gigantism
    End date: 2012-01-01



Possible Somavert side effects in 51 year old female

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

Patient: 51 year old female

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Somavert
    Dosage: 15 mg, 3 times a week
    Start date: 2012-06-01

Somavert
    Dosage: 10 mg, every day (7x week)
    Indication: Acromegaly
    Start date: 2011-12-01

Other drugs received by patient: Losartan; Levothyroxine; Hidrocortizon; Insulin; Pregabalin; Metformin; Omeprazole



Possible Somavert side effects in 62 year old female

Reported by a physician from Germany on 2012-08-07

Patient: 62 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Vitamin D Deficiency, Pruritus, Lichen Planus, Drug Ineffective, Urticaria, Rash

Drug(s) suspected as cause:
Lipitor
    Dosage: 20 mg, qd

Metformin Hydrochloride
    Dosage: 500 mg, bid

Somavert
    Dosage: 15 mg, qd

Zocor
    Administration route: Oral



Possible Somavert side effects in female

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

Patient: female, weighing 76.0 kg (167.2 pounds)

Reactions: Injection Site Pain, Insulin-Like Growth Factor Decreased

Drug(s) suspected as cause:
Somavert
    Dosage: 20 mg, 1x/day
    Indication: Acromegaly

Somavert
    Dosage: 10 mg, 1x/day

Other drugs received by patient: Vitamin E; Sandostatin LAR; Extra Strength Tylenol; Diovan HCT; Klor-CON M20; Novolog; Synthroid; Furosemide; Ferrous Sulfate TAB; Levemir; Metoclopramide; Multi-Vitamins



Possible Somavert side effects in

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

Patient:

Reactions: Vitamin D Deficiency, Lichen Planus, Pruritus, Drug Ineffective, Urticaria, Rash

Drug(s) suspected as cause:
Lipitor
    Dosage: 20 mg, qd

Metformin Hydrochloride
    Dosage: 500 mg, bid

Somavert
    Dosage: 15 mg, qd

Zocor
    Administration route: Oral



Possible Somavert side effects in female

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

Patient: female

Reactions: Fatigue, Dizziness, Depression

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: male, weighing 77.1 kg (169.6 pounds)

Reactions: Pain in Extremity

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Diovan



Possible Somavert side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: female

Reactions: Fatigue

Drug(s) suspected as cause:
Somavert
    Dosage: 10 mg, 1x/day
    Indication: Abnormal Behaviour
    Start date: 2012-06-01

Somavert
    Indication: Pituitary Tumour

Somavert
    Indication: Gigantism

Somavert
    Indication: Acromegaly

Other drugs received by patient: Crestor



Possible Somavert side effects in 51 year old female

Reported by a consumer/non-health professional from Argentina on 2012-07-16

Patient: 51 year old female

Reactions: Malaise, Diabetes Mellitus

Drug(s) suspected as cause:
Somavert
    Dosage: 15 mg, unk 7x week
    Start date: 2011-12-01

Somavert
    Dosage: 10 mg, unk 7x week



Possible Somavert side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: male, weighing 70.3 kg (154.6 pounds)

Reactions: Blood Pressure Increased, Psychomotor Hyperactivity, Blood Growth Hormone Increased, Rash, Decreased Appetite

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Synthroid; Restasis; Nexium; Adderall 5; Cymbalta; Toprol-XL; Lexapro; Cytomel; Aspirin



Possible Somavert side effects in 62 year old female

Reported by a physician from Germany on 2012-07-06

Patient: 62 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: female

Reactions: Fatigue, Dizziness, Depression

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in 42 year old female

Reported by a physician from Japan on 2012-07-03

Patient: 42 year old female

Reactions: Pituitary Tumour Benign

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Somavert
    Dosage: 15 mg, 1x/day
    Start date: 2007-12-18
    End date: 2010-06-28

Somavert
    Dosage: 10 mg, 1x/day
    Indication: Acromegaly
    Start date: 2007-07-03
    End date: 2007-12-17

Somavert
    Dosage: 20 mg, 1x/day
    Start date: 2010-06-29

Other drugs received by patient: Levothyroxine Sodium



Possible Somavert side effects in 40 year old female

Reported by a consumer/non-health professional from Canada on 2012-07-03

Patient: 40 year old female

Reactions: Weight Increased, Lipodystrophy Acquired

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Crestor



Possible Somavert side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: female, weighing 88.4 kg (194.5 pounds)

Reactions: Liver Function Test Abnormal, Insulin-Like Growth Factor Increased

Drug(s) suspected as cause:
Somavert
    Dosage: unk
    Indication: Insulin-Like Growth Factor Increased
    Start date: 2012-01-01
    End date: 2012-01-01

Somavert
    Dosage: unk
    Indication: Acromegaly
    Start date: 2011-01-01
    End date: 2012-01-01

Other drugs received by patient: Hydrochlorothiazide; Losartan; Somatuline Depot



Possible Somavert side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female

Reactions: Malaise, Vomiting, Nausea, Dyspepsia, Haemorrhoids, Constipation, Anal Fissure

Drug(s) suspected as cause:
Citrate Magnesia
    Dosage: unk

Sandostatin
    Dosage: unk

Somavert
    Dosage: unk



Possible Somavert side effects in male

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

Patient: male, weighing 70.3 kg (154.6 pounds)

Reactions: Blood Pressure Increased, Blood Growth Hormone Increased, Psychomotor Hyperactivity, Rash, Decreased Appetite

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Adderall 5; Cymbalta; Nexium; Cytomel; Acetylsalicylic Acid; Lexapro; Synthroid; Toprol-XL; Restasis



Possible Somavert side effects in female

Reported by a physician from United States on 2012-06-26

Patient: female

Reactions: Diarrhoea, Gastrointestinal Disorder

Drug(s) suspected as cause:
Somavert



Possible Somavert side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: male, weighing 70.3 kg (154.6 pounds)

Reactions: Blood Growth Hormone Increased, Rash, Decreased Appetite

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Synthroid; Nexium; Cytomel; Restasis; Lexapro; Acetylsalicylic Acid; Cymbalta



Possible Somavert side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Weight Increased, Headache

Drug(s) suspected as cause:
Hydrocortisone
    Dosage: unk
    Indication: Pituitary Tumour

Somavert
    Dosage: 30 mg, 1x/day
    Indication: Brain Neoplasm

Other drugs received by patient: Lasix



Possible Somavert side effects in female

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

Patient: female, weighing 73.9 kg (162.6 pounds)

Reactions: White Blood Cell Count Decreased, Depression

Drug(s) suspected as cause:
Somavert
    Dosage: 20 mg, 1x/day
    Indication: Insulin-Like Growth Factor Increased
    Start date: 2008-04-01

Somavert
    Dosage: 10 mg, 1x/day
    Start date: 2011-01-01

Other drugs received by patient: Hydrocortisone; Effexor; Levothyroxine; Testosterone; Thyroid; Progesterone



Possible Somavert side effects in female

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

Patient: female, weighing 73.9 kg (162.6 pounds)

Reactions: Vitamin B12 Deficiency

Drug(s) suspected as cause:
Somavert
    Dosage: 10 mg, 1x/day
    Start date: 2011-01-01
    End date: 2012-01-01

Somavert
    Dosage: 20 mg, 1x/day
    Indication: Insulin-Like Growth Factor Decreased
    Start date: 2008-04-01
    End date: 2011-01-01

Other drugs received by patient: Progesterone; Testosterone; Levothyroxine; Effexor; Hydrocortisone; Estrogen NOS



Possible Somavert side effects in female

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

Patient: female, weighing 73.9 kg (162.6 pounds)

Reactions: Faecal Incontinence

Drug(s) suspected as cause:
Somavert

Other drugs received by patient: Levothyroxine; Effexor; Hydrocortisone; Estrogen; Testosterone; Progesterone

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