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Index of reports
> Cases with Hypoglycaemia (21)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Levemir (Insulin Detemir Subcutaneous) where reactions include hypoglycaemia. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Levemir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09
Patient: male
Reactions: Hypoglycaemia, Renal Failure Chronic
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 53 year old female
Reported by a physician from Japan on 2012-08-07
Patient: 53 year old female
Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Novorapid CHU Flexpen
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Levemir
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Start date: 2011-09-01
Other drugs received by patient: Lantus; Magmitt; Trazodone Hydrochloride; Ubretid; Benzalin / 00036201 /
Possible Levemir side effects in 53 year old female
Reported by a physician from Japan on 2012-07-26
Patient: 53 year old female
Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Novorapid CHU Flexpen
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Levemir
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Other drugs received by patient: Lantus
Possible Levemir side effects in female
Reported by a consumer/non-health professional from Australia on 2012-07-20
Patient: female
Reactions: Drug Dose Omission, Malaise, Device Misuse, Wrong Drug Administered, Hypoglycaemia, Bronchitis, Accidental Overdose, Lower Respiratory Tract Infection
Drug(s) suspected as cause:
Humalog
Indication: Product Used FOR Unknown Indication
Rebif
Indication: Product Used FOR Unknown Indication
Start date: 2010-05-17
Levemir
Indication: Product Used FOR Unknown Indication
Possible Levemir side effects in 53 year old female
Reported by a physician from Japan on 2012-07-20
Patient: 53 year old female
Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia, Dementia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-05-11
Patient: 72 year old male
Reactions: Dyspnoea, Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Saxagliptin
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-02-06
Metformin HCL
Dosage: 1700 mg, qd
Indication: Type 2 Diabetes Mellitus
Levemir
Dosage: 60 iu, qd
Indication: Type 2 Diabetes Mellitus
Glibetic / 00145301 /
Dosage: 10 mg, qd
Indication: Type 2 Diabetes Mellitus
End date: 2011-11-01
Possible Levemir side effects in 53 year old male
Reported by a physician from United States on 2012-05-11
Patient: 53 year old male, weighing 91.8 kg (202.0 pounds)
Reactions: Metabolic Acidosis, Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: unk
Indication: Product Used FOR Unknown Indication
Gliclazide
Dosage: unk
Indication: Product Used FOR Unknown Indication
Metoprolol Tartrate
Dosage: unk
Sorafenib
Dosage: 400 mg, bid, total dose 33600 mg
Administration route: Oral
Indication: Renal Cell Carcinoma
End date: 2010-08-24
Sorafenib
Dosage: unk
Avandamet
Dosage: unk
Indication: Product Used FOR Unknown Indication
Sunitinib Malate
Dosage: unk
Januvia
Dosage: unk
Indication: Product Used FOR Unknown Indication
Sunitinib Malate
Dosage: 50 mg, qd (weeks 1-4)
Indication: Renal Cell Carcinoma
Start date: 2009-12-16
Sunitinib Malate
Dosage: total dose 1400 mg
End date: 2010-08-10
Other drugs received by patient: Aspirin; Avalide; Caduet; Lisinopril
Possible Levemir side effects in 53 year old male
Reported by a physician from United States on 2012-05-03
Patient: 53 year old male, weighing 91.8 kg (202.0 pounds)
Reactions: Metabolic Acidosis, Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Avandamet
Gliclazide MR
Nexavar
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2009-12-16
Levemir
Metoprolol Tartrate
Administration route: Oral
Placebo
Sutent
Administration route: Oral
Indication: Renal Cell Carcinoma
Start date: 2009-12-16
Januvia
Other drugs received by patient: Caduet; Lisinopril; Aspirin; Avalide
Possible Levemir side effects in 53 year old male
Reported by a physician from Canada on 2012-04-27
Patient: 53 year old male
Reactions: Alcohol Use, Metabolic Acidosis, Anion GAP Increased, Vomiting Projectile, Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoprolol Tartrate
Indication: Product Used FOR Unknown Indication
Levemir
Indication: Product Used FOR Unknown Indication
Blinded Therapy
Indication: Renal Cell Carcinoma
Start date: 2009-12-16
Blinded Therapy
Dosage: unk;unk
Indication: Renal Cell Carcinoma
Start date: 2009-12-16
Avandamet
Indication: Product Used FOR Unknown Indication
Sitagliptin Phosphate
Dosage: po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Gliclazide
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Aspirin; Diamicron; Caduet; Avalide; Lisinopril
Possible Levemir side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: 70 year old male
Reactions: Wrong Drug Administered, Hypoglycaemia
Drug(s) suspected as cause:
Novolin R
Dosage: sliding scale, qid, subcutaneous
Indication: Type 2 Diabetes Mellitus
Levemir
Dosage: 110 u, qd at bedtime, subcutaneous
Indication: Type 2 Diabetes Mellitus
Possible Levemir side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-15
Patient: male
Reactions: Hypoglycaemia, Hyperhidrosis
Drug(s) suspected as cause:
Glyburide
Administration route: Oral
Levemir
Dosage: dose:5 unit(s)
Levemir
Dosage: dose:10 unit(s)
Metformin HCL
Other drugs received by patient: Januvia
Possible Levemir side effects in female
Reported by a physician from United States on 2011-12-23
Patient: female
Reactions: Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 70 year old male
Reported by a physician from Japan on 2011-12-23
Patient: 70 year old male
Reactions: Anti-Insulin Antibody, Hypoglycaemia, Hyperglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 6 u, qd
Indication: Type 2 Diabetes Mellitus
Start date: 2009-06-10
End date: 2009-06-24
Novolin R
Indication: Type 2 Diabetes Mellitus
Other drugs received by patient: Humalog MIX 50; Humacart N; Humalog
Possible Levemir side effects in female
Reported by a physician from United States on 2011-12-23
Patient: female
Reactions: Hypoglycaemia
Drug(s) suspected as cause:
Humalog
Dosage: sliding scale, subcutaneous
Indication: Diabetes Mellitus
Levemir
Dosage: subcutaneous
Indication: Diabetes Mellitus
Possible Levemir side effects in 67 year old female
Reported by a physician from United States on 2011-12-23
Patient: 67 year old female
Reactions: Hypoglycaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Placebo
Indication: Type 2 Diabetes Mellitus
Insulin Glargine (Insulin Glargine)
Indication: Type 2 Diabetes Mellitus
Levemir
Dosage: 48 iu, qd, subcutaneous
Indication: Type 2 Diabetes Mellitus
Start date: 2011-04-07
Saxagliptin (Saxagliptin)
Indication: Type 2 Diabetes Mellitus
Start date: 2011-02-15
Other drugs received by patient: Aspirin; Lovenox; Labetalol HCL
Possible Levemir side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2011-12-23
Patient: 70 year old male
Reactions: Wrong Drug Administered, Hypoglycaemia
Drug(s) suspected as cause:
Levemir
Dosage: 110 u, qd at bedtime, subcutaneous
Indication: Type 2 Diabetes Mellitus
Novolin R
Dosage: sliding scale, qid, subcutaneous
Indication: Type 2 Diabetes Mellitus
Possible Levemir side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2011-11-30
Patient: 70 year old male, weighing 116.6 kg (256.5 pounds)
Reactions: Hypoglycaemia
Drug(s) suspected as cause:
Novolog
Dosage: 5 u, tid before meals, subcutaneous
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Levemir
Dosage: 25 u, qd every morning, subcutaneous
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Possible Levemir side effects in male
Reported by a physician from United States on 2011-11-30
Patient: male
Reactions: Hypoglycaemia, Diabetic Ketoacidosis, Blood Glucose Increased
Drug(s) suspected as cause:
Levemir
Indication: Diabetes Mellitus
Novolog
Indication: Diabetes Mellitus
Possible Levemir side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-30
Patient: female
Reactions: Hypoglycaemia
Drug(s) suspected as cause:
Novolog
Dosage: unknown
Indication: Type 2 Diabetes Mellitus
Levemir
Dosage: unknown, subcutaneous
Indication: Type 2 Diabetes Mellitus
Cymbalta
Dosage: unk
Indication: Arthralgia
Start date: 2011-08-01
Other drugs received by patient: Synthroid; Toprol-XL; Nitroglycerin
Possible Levemir side effects in
Reported by a consumer/non-health professional from United States on 2011-11-16
Patient:
Reactions: Hypoglycaemia, Atrial Fibrillation, Convulsion, Oesophageal Candidiasis, Overdose, Oral Candidiasis, Diabetic Coma, Dizziness, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 34 u, bid
Indication: Diabetes Mellitus
Novolog
Dosage: scale before breakfast, lunch, dinner and even bedtime
Indication: Diabetes Mellitus
Start date: 2009-06-25
Other drugs received by patient: Metoprolol Succinate; Avapro; Pantoprazole; Amlodipine
Possible Levemir side effects in
Reported by a consumer/non-health professional from Brazil on 2011-10-04
Patient:
Reactions: Abdominal Pain, Pain in Extremity, Hyperglycaemia, Hypoglycaemia, Growth Retardation, Headache, Hypoaesthesia, Cardiac Arrest, Lipodystrophy Acquired, Diabetes Mellitus Inadequate Control, Atrophy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 28 u, qd
Indication: Type 1 Diabetes Mellitus
Start date: 2001-01-01
Novorapid Flexpen
Dosage: ranges according to glycaemia / sc
Indication: Type 1 Diabetes Mellitus
Start date: 2001-01-01
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