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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: 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 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 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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