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Symlin (Pramlintide Subcutaneous) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Symlin (Pramlintide Subcutaneous) 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 (17)
Death (2)

Reports by Reaction Type

Nausea (4)Pain (3)Loss of Consciousness (3)Glycosylated Haemoglobin Increased (3)Blood Glucose Increased (3)Respiratory Distress (3)Blood Glucose Decreased (3)Wrong Technique in Drug Usage Process (2)Fall (2)Weight Increased (2)Overdose (2)Drug Effect Decreased (2)

Possible Symlin side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 57 year old male

Reactions: Back Pain, Glycosylated Haemoglobin Increased, Drug Effect Decreased

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Neurontin; Novolog



Possible Symlin side effects in 40 year old female

Reported by a consumer/non-health professional on 2012-06-29

Patient: 40 year old female, weighing 76.2 kg (167.6 pounds)

Reactions: Drug Effect Decreased, Nausea, Convulsion, Blood Glucose Decreased, Weight Increased, Overdose, Glycosylated Haemoglobin Increased, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin
    Dosage: 120 mcg;sc
    Indication: Type 1 Diabetes Mellitus

Symlin
    Dosage: 120 mcg;sc 60 mcg;sc 60 mcg;bidsc 30 mcg;bid;sc
    Indication: Type 1 Diabetes Mellitus
    End date: 2011-09-01

Symlin
    Dosage: 120 mcg;sc 60 mcg;sc 60 mcg;bidsc 30 mcg;bid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-06-01

Symlin
    Dosage: 120 mcg;sc 60 mcg;sc 60 mcg;bidsc 30 mcg;bid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-06-08

Symlin
    Dosage: 120 mcg;sc 60 mcg;sc 60 mcg;bidsc 30 mcg;bid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2011-12-01
    End date: 2012-02-01

Symlin
    Dosage: 120 mcg;sc 60 mcg;sc 60 mcg;bidsc 30 mcg;bid;sc
    Indication: Type 1 Diabetes Mellitus

Other drugs received by patient: Humalog; Reglan; Novolog



Possible Symlin side effects in 70 year old male

Reported by a consumer/non-health professional on 2012-06-14

Patient: 70 year old male, weighing 108.0 kg (237.5 pounds)

Reactions: Drug Dose Omission, Condition Aggravated, Cardiac Failure Congestive, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin
    Dosage: 120 mcg; ; sc;
    Indication: Diabetes Mellitus
    Start date: 2012-05-11

Symlin
    Dosage: 120 mcg; ; sc;
    Indication: Diabetes Mellitus
    End date: 2012-05-11

Other drugs received by patient: Albuterol; Lantus; Prednisone TAB; Metoprolol Tartrate; Albuterol Sulfate; Spiriva; Famotidine; Triamcinolone Acetaone; Rosuvastatin; Novolog; Ropinirole; Hydrocodone Bitartrate and Acetaminophen; Clobetasol Propionate; Aspirin; Furosemide; Plavix; Metolazone; Singulair; Halobetasol Propionate; Advair Diskus 100 / 50; Salacylic Acid



Possible Symlin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-04-18

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Loss of Consciousness

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Novolog; Lantus



Possible Symlin side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-03-12

Patient: 60 year old female, weighing 67.1 kg (147.7 pounds)

Reactions: Hypoglycaemia, Feeling Abnormal, Fall, Ankle Fracture

Drug(s) suspected as cause:
Symlin
    Dosage: 5 units; bid; sc 10 units; bid sc 7.5 units; bid;sc 5 units;bid;sc 2.5 units;bid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2005-01-01

Symlin
    Dosage: 5 units; bid; sc 10 units; bid sc 7.5 units; bid;sc 5 units;bid;sc 2.5 units;bid;sc
    Indication: Type 1 Diabetes Mellitus
    End date: 2011-11-03

Symlin
    Dosage: 30 mcg;bid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2011-11-04

Other drugs received by patient: Simvastatin; Lantus; Humalog



Possible Symlin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-02-15

Patient: female

Reactions: Loss of Consciousness

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Novolog



Possible Symlin side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: female

Reactions: Nausea, Cardiac Operation

Drug(s) suspected as cause:
Symlin



Possible Symlin side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-02-14

Patient: 67 year old male

Reactions: Pain, Rotator Cuff Repair, Respiratory Distress, Resuscitation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Humalog; Levemir



Possible Symlin side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: 49 year old female, weighing 179.2 kg (394.2 pounds)

Reactions: Perfume Sensitivity, Abdominal Pain, Agitation, Asthma, Wrong Technique in Drug Usage Process, Drug Ineffective, Unresponsive To Stimuli, Pain, Weight Increased, Overdose, Glycosylated Haemoglobin Increased, Dizziness, Depression, Pneumonia, Vomiting, Hyperglycaemia, Hypotension, Hernia Repair, Drug Prescribing Error, Respiratory Distress, Blood Glucose Decreased, Dysstasia, Urine Ketone Body Present, Suicide Attempt, Abscess, Sluggishness, Cardiac Arrest, Needle Issue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin
    Dosage: 120 mcg;tid;sc ; 60 mcg;tid;sc ; 45 mcg;tid;sc ; 30 mcg;tid;sc ; 120 mcg;tid;sc
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-12-21

Symlin
    Dosage: 120 mcg;tid;sc ; 60 mcg;tid;sc ; 45 mcg;tid;sc ; 30 mcg;tid;sc ; 120 mcg;tid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2011-12-21

Symlin
    Dosage: 120 mcg;tid;sc ; 60 mcg;tid;sc ; 45 mcg;tid;sc ; 30 mcg;tid;sc ; 120 mcg;tid;sc
    Indication: Type 2 Diabetes Mellitus
    Start date: 2005-12-01
    End date: 2005-12-01

Symlin
    Dosage: 120 mcg;tid;sc ; 60 mcg;tid;sc ; 45 mcg;tid;sc ; 30 mcg;tid;sc ; 120 mcg;tid;sc
    Indication: Type 1 Diabetes Mellitus
    Start date: 2005-12-01
    End date: 2005-12-01

Symlin
    Dosage: 120 mcg;tid;sc ; 60 mcg;tid;sc ; 45 mcg;tid;sc ; 30 mcg;tid;sc ; 120 mcg;tid;sc
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-09-01

Symlin
    Dosage: 120 mcg;tid;sc ; 60 mcg;tid;sc ; 45 mcg;tid;sc ; 30 mcg;tid;sc ; 120 mcg;tid;sc
    Indication: Type 1 Diabetes Mellitus
    End date: 2011-09-01

Symlin
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-09-01
    End date: 2011-12-20

Symlin
    Indication: Type 1 Diabetes Mellitus
    Start date: 2011-09-01
    End date: 2011-12-20

Other drugs received by patient: Insulin; Novolog; Mucinex; Synthroid; Prozac; Humulin U; Advair Diskus 100 / 50; Valium; Veramist Nasal Spray; Percocet; Phenergan; Exforge; Clonidine; Meclizine; Ventolin; Prozac; Neurontin; Spironolactone; Zoloft; Lisinopril; Cardovil; Reglan; Restoril; Lasix; Nexium; Skelaxin; Ondansetron HCL; Xanax



Possible Symlin side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: 67 year old male

Reactions: Pain, Rotator Cuff Repair, Respiratory Distress

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Levemir; Humalog



Possible Symlin side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-01

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Blood Pressure Increased, Amnesia, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Insulin



Possible Symlin side effects in female

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

Patient: female

Reactions: Nausea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin



Possible Symlin side effects in 72 year old female

Reported by a physician from United States on 2011-11-04

Patient: 72 year old female

Reactions: Breast Cancer, Vomiting, Osteonecrosis, Arthralgia, Sinus Disorder, Hepatic Neoplasm, Renal Neoplasm

Drug(s) suspected as cause:
Symlin
    Dosage: 180 mcg;tid;sc 60 mcg;tid;sc 120 mcg;tid;sc
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-06-01

Symlin
    Dosage: 180 mcg;tid;sc 60 mcg;tid;sc 120 mcg;tid;sc
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-06-01

Symlin
    Dosage: sc
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Antibiotics; Humalog



Possible Symlin side effects in 49 year old female

Reported by a physician from United States on 2011-11-02

Patient: 49 year old female

Reactions: Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Lantus; Novolog



Possible Symlin side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: female

Reactions: Suicidal Ideation

Drug(s) suspected as cause:
Symlin

Other drugs received by patient: Insulin



Possible Symlin side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: male

Reactions: Aphagia, Blood Glucose Decreased, Nausea, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Symlin



Possible Symlin side effects in

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient:

Reactions: Cataract Operation

Drug(s) suspected as cause:
Symlin
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 70 u, qd
    Indication: Type 2 Diabetes Mellitus

Novolog
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 100 u, unk

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