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Novolog (Insulin Aspart Injection) - Dehydration - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Dehydration (16)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Novolog (Insulin Aspart Injection) where reactions include dehydration. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Novolog side effects in female

Reported by a physician from United States on 2012-07-06

Patient: female, weighing 79.3 kg (174.5 pounds)

Reactions: Vomiting, Nausea, Urinary Tract Infection, Concomitant Disease Progression, Syncope, Dehydration, Vertigo, Fibula Fracture, Electrolyte Imbalance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-19
    End date: 2011-07-09

Lantus
    Dosage: 45 iu, qd
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-08-01

Novolog
    Dosage: 46 iu, bid
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-08-01

Diltiazem Hydrocholoride
    Dosage: 180 mg, unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-02-19

Hydrochlorothiazide
    Dosage: 25 mg, qd
    Administration route: Oral
    End date: 2011-08-01

Irbesartan
    Dosage: 75 mg, q5w
    End date: 2011-08-01

Cyclobenzaprine
    Dosage: 20 mg, qhs
    Administration route: Oral
    End date: 2011-08-01

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-19
    End date: 2011-07-09

Cyclobenzaprine
    Dosage: 05 mg, qhs
    Administration route: Oral
    Start date: 2011-08-04

Blinded Aliskiren
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-19
    End date: 2011-07-09

Other drugs received by patient: Wellbutrin; Alka-Seltzer; Mevacor; Colace; Fluticasone Propionate; Levothyroxine Sodium; Avapro; Niacin; Synthroid; Multi-Vitamins; Lovastatin; Casanthranol W / Docusate Sodium; Prilosec; Glucosamine W / Chondroitin; Naproxen; Polyethylene Glycol; Omeprazole



Possible Novolog side effects in female

Reported by a physician from United States on 2012-07-02

Patient: female, weighing 79.3 kg (174.5 pounds)

Reactions: Vomiting, Nausea, Urinary Tract Infection, Concomitant Disease Progression, Syncope, Dehydration, Vertigo, Fibula Fracture, Electrolyte Imbalance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrochlorothiazide
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-08-01

Diltiazem Hydrocholoride
    Dosage: 180 mg, unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-02-19

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-19
    End date: 2011-07-09

Irbesartan
    Dosage: 75 mg, q5w
    Indication: Hypertension
    End date: 2011-08-01

Novolog
    Dosage: 46 iu, bid
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-08-01

Blinded Aliskiren
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-19
    End date: 2011-07-09

Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-19
    End date: 2011-07-09

Cyclobenzaprine
    Dosage: 20 mg, qhs
    Administration route: Oral
    Indication: Muscle Spasms
    End date: 2011-08-01

Cyclobenzaprine
    Dosage: 05 mg, qhs
    Administration route: Oral
    Start date: 2011-08-04

Lantus
    Dosage: 45 iu, qd
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-08-01

Other drugs received by patient: Levothyroxine Sodium; Naproxen; Mevacor; Alka-Seltzer; Polyethylene Glycol; Colace; Niacin; Synthroid; Prilosec; Multi-Vitamins; Avapro; Wellbutrin; Fluticasone Propionate; Glucosamine W / Chondroitin; Lovastatin; Casanthranol W / Docusate Sodium; Omeprazole



Possible Novolog side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: 86 year old female, weighing 54.0 kg (118.7 pounds)

Reactions: Dyspnoea, Oedema Peripheral, Dehydration, Abdominal Distension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levemir
    Dosage: unknown
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-04-01

Novolog
    Dosage: unknown
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Aranesp; Digoxin



Possible Novolog side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: 86 year old female, weighing 54.0 kg (118.7 pounds)

Reactions: Dehydration, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog
    Dosage: unknown
    Indication: Type 2 Diabetes Mellitus

Levemir
    Dosage: unknown
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Digoxin; Aranesp



Possible Novolog side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) on 2012-04-25

Patient: 60 year old male

Reactions: Portal Hypertension, Pancreatitis Acute, Sudden Cardiac Death, Pulmonary Embolism, Gastric Varices, Constipation, Chest Pain, Hepatic Cirrhosis, Cough, Right Ventricular Failure, Dyspnoea, Nausea, Portal Vein Thrombosis, Haematuria, Ascites, Arrhythmia, Dehydration, Pancreatitis, Inguinal Hernia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Metformin HCL
    Dosage: 1.5 gm
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-07-11

Lactulose
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-20
    End date: 2011-07-25

Cilaxoral (Sodium Picosulfate)
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-12
    End date: 2011-07-25

Blinded Therapy
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-14

Isophane Insulin
    Dosage: 8 iu
    Indication: Diabetes Mellitus
    Start date: 2011-07-18

Novolog
    Dosage: 8 iu
    Indication: Diabetes Mellitus
    Start date: 2011-07-11
    End date: 2011-07-19

Dalteparin Sodium
    Dosage: 1500 iu, 1 d
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-11

Acetylsalicylic Acid SRT
    Dosage: 75 mg
    Indication: Product Used FOR Unknown Indication
    End date: 2011-07-22

Clopidogrel
    Dosage: 75 mg
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Spironolactone; Importal (Lactitol); Omeprazole; Oxycontin; Aspirin; Furosemide



Possible Novolog side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: 64 year old male, weighing 73.9 kg (162.6 pounds)

Reactions: Malaise, Drug Ineffective, Hyperglycaemia, Dehydration

Drug(s) suspected as cause:
Novolog
    Dosage: sliding scale tid and prn 2-3u at bedtime
    End date: 2012-03-01

Novolog
    Dosage: increased doses up to 20u tid
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-03-01

Other drugs received by patient: Excedrin / 00110301 /; Lantus



Possible Novolog side effects in 60 year old male

Reported by a physician from United States on 2012-04-03

Patient: 60 year old male

Reactions: Pancreatitis Acute, Sudden Cardiac Death, Nausea, Haematuria, Portal Vein Thrombosis, Pulmonary Embolism, Constipation, Ascites, Arrhythmia, Dehydration, Inguinal Hernia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Metformin HCL
    Dosage: 1.5 g, unk
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-07-11

Aspirin
    Dosage: 75 mg, unk
    End date: 2011-07-22

Dalteparin Sodium
    Dosage: 1 dosage form 1 day
    Start date: 2011-07-11

Insulatard NPH Human
    Dosage: 8 international unit
    Indication: Diabetes Mellitus
    Start date: 2011-07-18

Placebo
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-14
    End date: 2011-07-11

Saxagliptin (Saxagliptin)
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-14
    End date: 2011-07-11

Novolog
    Dosage: 8 international unit
    Indication: Diabetes Mellitus
    Start date: 2011-07-11
    End date: 2011-07-19

Sodium Picosulfate (Sodium Picosulfate)
    Dosage: unk
    Start date: 2011-07-12
    End date: 2011-07-25

Lactulose
    Dosage: unk
    Start date: 2011-07-20
    End date: 2011-07-25

Clopidogrel
    Dosage: 75 mg, unk

Other drugs received by patient: Furosemide; Spironolactone; Oxycontin; Importal (Lactitol); Omeprazole



Possible Novolog side effects in 23 year old female

Reported by a consumer/non-health professional from United States on 2012-04-03

Patient: 23 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Drug Effect Decreased, Palpitations, Dehydration, Pollakiuria, Hypertension, Blood Glucose Increased, Lethargy

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) on 2012-04-02

Patient: 60 year old male

Reactions: Portal Hypertension, Abdominal Pain, Pancreatitis Acute, Sudden Cardiac Death, Dilatation Ventricular, Pulmonary Embolism, Constipation, Cough, Hepatic Cirrhosis, Right Ventricular Failure, Nausea, Portal Vein Thrombosis, Haematuria, Ascites, Dehydration, Inguinal Hernia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novolog
    Dosage: (8 iu), unknown
    Indication: Diabetes Mellitus
    Start date: 2011-07-11
    End date: 2011-07-19

Blinded Therapy
    Dosage: unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-14

Acetylsalicylic Acid SRT
    Dosage: (75 mg), unknown
    Indication: Product Used FOR Unknown Indication
    End date: 2011-07-22

Isophane Insulin
    Dosage: (8 iu), unknown
    Indication: Diabetes Mellitus
    Start date: 2011-07-18

Metformin HCL
    Dosage: (1.5 gm), unknown
    Indication: Type 2 Diabetes Mellitus

Cilaxoral (Sodium Picosulfate)
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-12
    End date: 2011-07-25

Lactulose
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-20
    End date: 2011-07-25

Dalteparin Sodium
    Dosage: (1500 iu, 1 d), unknown
    Indication: Product Used FOR Unknown Indication

Clopidogrel
    Dosage: (75 mg), unknown
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Importal (Lactitol); Aspirin; Omeprazole; Oxycontin; Spironolactone; Furosemide



Possible Novolog side effects in male

Reported by a physician from United States on 2012-03-27

Patient: male

Reactions: Off Label Use, Vomiting, Renal Failure, Dehydration, Blood Potassium Increased, Blood Sodium Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog

Doxycycline
    Start date: 2011-06-06
    End date: 2011-07-06

Sulfamethoxazole and Trimethoprim
    Start date: 2011-06-06
    End date: 2011-07-06

Placebo
    Start date: 2010-08-06

Saxagliptin
    Start date: 2010-08-06

Avandia

Insulin Human (Humalin)

Other drugs received by patient: Aspirin; Ezetimibe



Possible Novolog side effects in 27 year old male

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 27 year old male, weighing 76.2 kg (167.6 pounds)

Reactions: Dehydration, Diabetic Ketoacidosis, Gastroenteritis Viral, Blood Glucose Increased

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in 46 year old female

Reported by a physician from Netherlands on 2012-02-15

Patient: 46 year old female

Reactions: Dehydration, Enteritis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Therapy
    Dosage: unk;unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-26

Novolog
    Dosage: 27 iu/unk/unk
    Indication: Type 2 Diabetes Mellitus

Hydrodiuril
    Dosage: unk;unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk;unk
    Indication: Product Used FOR Unknown Indication

Prinivil
    Dosage: unk;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01
    End date: 2011-01-01

Lantus
    Dosage: 20 iu/unk/unk
    Indication: Type 2 Diabetes Mellitus

Metformin HCL
    Dosage: 500 mg/unk/unk
    Indication: Type 2 Diabetes Mellitus

Celebrex
    Dosage: unk;unk

Other drugs received by patient: Aspirin



Possible Novolog side effects in 27 year old male

Reported by a consumer/non-health professional from United States on 2012-02-10

Patient: 27 year old male, weighing 76.2 kg (167.6 pounds)

Reactions: Dehydration, Diabetic Ketoacidosis, Gastroenteritis Viral, Blood Glucose Increased

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in female

Reported by a physician from United States on 2011-11-08

Patient: female, weighing 79.3 kg (174.5 pounds)

Reactions: Syncope, Dehydration, Electrolyte Imbalance, Fibula Fracture, Concomitant Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Irbesartan
    Dosage: 75 mg, q5w
    Indication: Hypertension
    End date: 2011-08-01

Cyclobenzaprine
    Dosage: 20 mg, qhs
    Administration route: Oral
    Indication: Muscle Spasms
    End date: 2011-08-01

Lantus
    Dosage: 45 iu, qd
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-08-01

Diltiazem HCL
    Dosage: 180 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-08-01

Novolog
    Dosage: 46 iu, bid
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-08-01

Cyclobenzaprine
    Dosage: 10 mg, qhs
    Administration route: Oral

Hydrochlorothiazide
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-08-01

Blinded Placebo
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-10
    End date: 2011-07-22

Blinded Aliskiren
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-10
    End date: 2011-07-22

Blinded NO Treatment Received
    Dosage: code not broken
    Administration route: Oral
    Indication: Cardiovascular Disorder
    Start date: 2009-06-10
    End date: 2011-07-22

Other drugs received by patient: Lovastatin; Centrum Silver; Colace; Fluticasone Propionate; Avapro; Niacin; Naproxen; Glucosamine W / Chondroitin; Levothyroxine Sodium; Prilosec



Possible Novolog side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) on 2011-10-24

Patient: 60 year old male

Reactions: Pancreatitis Acute, Dilatation Ventricular, Sudden Cardiac Death, Portal Vein Thrombosis, Haematuria, Pulmonary Embolism, Constipation, Ascites, Arrhythmia, Dehydration, Hepatic Cirrhosis, Inguinal Hernia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isophane Insulin
    Dosage: (8 iu)
    Indication: Diabetes Mellitus
    Start date: 2011-07-18

Metformin HCL
    Dosage: (1.5 gm)
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-07-11

Dalteparin Sodium
    Dosage: (1500 iu, 1 d)
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-11

Acetylsalicylic Acid SRT
    Dosage: (75 mg)
    Indication: Product Used FOR Unknown Indication
    End date: 2011-07-22

Novolog
    Dosage: (8 iu)
    Indication: Diabetes Mellitus
    Start date: 2011-07-11
    End date: 2011-07-19

Clopidogrel
    Dosage: (75 mg)
    Indication: Product Used FOR Unknown Indication

Lactulose
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-20
    End date: 2011-07-25

Blinded Therapy
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-14

Cilaxoral (Sodium Picosulfate)
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-12
    End date: 2011-07-25

Other drugs received by patient: Oxycontin; Omeprazole; Aspirin; Importal (Lactitol); Furosemide; Spironolactone



Possible Novolog side effects in

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient:

Reactions: Dehydration

Drug(s) suspected as cause:
Novolog

Other drugs received by patient: Lantus; Lisinopril; Zocor; Hydrochlorothiazide; Fosamax

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