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Index of reports
> Cases with Product Quality Issue (272)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lantus (Insulin Glargine) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 272 Next >>
Possible Lantus side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: male
Reactions: Product Quality Issue, LEG Amputation
Drug(s) suspected as cause:
Lantus
Dosage: 18-21 units daily according to what he is planning on doing that day
Solostar
Possible Lantus side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient:
Reactions: Product Quality Issue, Bedridden, Emphysema, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Atenolol
Dosage: 25 mg, qd
Administration route: Oral
Nitrostat
Dosage: 0.4 mg, prn
Lantus
Dosage: 170 df, qd
Tylenol W / Codeine NO. 3
Dosage: unk, qd
Methocarbamol
Dosage: 750 mg, prn
Administration route: Oral
Dilantin
Dosage: 300 mg, bid
Administration route: Oral
Zocor
Dosage: 40 mg, qd
Administration route: Oral
Norvasc
Administration route: Oral
Depakote
Dosage: 500 mg, bid
Administration route: Oral
Humulin R
Dosage: 24 df, tid
Ativan
Dosage: 1 mg, tid
Administration route: Oral
Potassium Chloride
Dosage: 8 meq, unk
Aspirin
Dosage: 81 mg, prn
Administration route: Oral
Lomotil
Dosage: 2.5 mg, qid
Administration route: Oral
Isosorbide Mononitrate
Dosage: 30 mg, tid
Administration route: Oral
Zantac
Dosage: 300 mg, tid
Furosemide
Dosage: 40 mg, bid
Administration route: Oral
Lactulose
Dosage: 30 mg, prn
Remeron
Dosage: 30 mg, qd
Administration route: Oral
Possible Lantus side effects in
Reported by a pharmacist from United States on 2012-07-23
Patient:
Reactions: Product Quality Issue, Device Malfunction
Drug(s) suspected as cause:
Lantus
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: female
Reactions: Product Quality Issue, Blood Glucose Decreased, Product Substitution Issue, Injection Site Haemorrhage, Blood Glucose Increased
Drug(s) suspected as cause:
Lantus
Dosage: 40 iu, 1x/day
Indication: Type 2 Diabetes Mellitus
Glipizide
Dosage: 10 mg, unk
Glipizide
Dosage: 20 mg,2x/day (in the morning and evening)
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: female
Reactions: Product Quality Issue, Ketosis, Hypoglycaemia, Blood Glucose Increased
Drug(s) suspected as cause:
Solostar
Lantus
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female
Reactions: Ketosis, Product Quality Issue, Hypoglycaemia, Blood Glucose Increased
Drug(s) suspected as cause:
Lantus
Solostar
Possible Lantus side effects in
Reported by a physician from United Kingdom on 2012-05-16
Patient:
Reactions: Product Quality Issue, Wrong Drug Administered, Drug Administration Error, Diabetic Ketoacidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: strength: 300iu/3ml
Lantus
Dosage: strength: 300iu/3ml
Possible Lantus side effects in 60 year old male
Reported by a pharmacist from United States on 2012-05-15
Patient: 60 year old male
Reactions: Product Quality Issue, Visual Impairment, Eye Swelling, Product Contamination Physical
Drug(s) suspected as cause:
Lantus
Dosage: dose:60 unit(s)
Start date: 2011-12-01
Solostar
Start date: 2011-12-01
Possible Lantus side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-05-07
Patient: 56 year old female
Reactions: Product Quality Issue, Pain in Extremity, Nodule, Asthenia
Drug(s) suspected as cause:
Lantus
Dosage: dose:60 unit(s)
Start date: 2011-01-01
End date: 2012-03-01
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Other drugs received by patient: Apidra
Possible Lantus side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-05-02
Patient: 56 year old female
Reactions: Product Quality Issue, Pain in Extremity, Limb Injury, Device Difficult To Use, Nodule, Muscular Weakness, Asthenia
Drug(s) suspected as cause:
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Lantus
Dosage: dose:60 unit(s)
Start date: 2011-01-01
End date: 2012-03-01
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Other drugs received by patient: Apidra
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-01
Patient: female
Reactions: Product Quality Issue, Dizziness, Blood Glucose Increased
Drug(s) suspected as cause:
Solostar
Apidra
Solostar
Lantus
Dosage: dose:40 unit(s)
Other drugs received by patient: Metformin HCL
Possible Lantus side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-04-19
Patient: 56 year old female
Reactions: Product Quality Issue, Pain in Extremity, Nodule, Asthenia
Drug(s) suspected as cause:
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Lantus
Dosage: dose:60 unit(s)
Start date: 2011-01-01
End date: 2012-03-01
Other drugs received by patient: Apidra
Possible Lantus side effects in 48 year old female
Reported by a individual with unspecified qualification from United States on 2012-04-13
Patient: 48 year old female, weighing 90.0 kg (198.0 pounds)
Reactions: Bedridden, Emphysema, Product Quality Issue, Amnesia, Chronic Obstructive Pulmonary Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lomotil
Dosage: 10 mg (2.5 mg,4 in 1 d),oral
Administration route: Oral
Indication: Crohn's Disease
Potassium Chloride
Dosage: (8 milliequivalents-
Indication: Blood Potassium Normal
Methocarbamol
Dosage: (750 mg,as required),oral
Administration route: Oral
Indication: Muscle Spasms
Aspirin
Dosage: (81 mg,as required)
Indication: Chest Pain
Furosemide
Dosage: 80 mg (40 mg,2 in 1 d),oral
Administration route: Oral
Indication: Diuretic Therapy
Isosorbide Mononitrate
Dosage: 90 mg (30 mg,3 in 1 d)
Indication: Cardiac Disorder
Remeron
Dosage: (30 mg,1 d),oral
Administration route: Oral
Indication: Insomnia
Atenolol
Dosage: (25 mg,1 d),oral
Administration route: Oral
Indication: Hypertension
Humulin R
Dosage: 72 iu (24 iu,3 in 1 d)
Indication: Diabetes Mellitus
Lantus
Dosage: (170, 80 units morning and 90 units night)
Indication: Diabetes Mellitus
Ativan
Dosage: 3 mg (1 mg,3 in 1 d),oral
Administration route: Oral
Indication: Anxiety
Depakote
Dosage: 1000 mg (500 mg,2 in 1 d),oral
Administration route: Oral
Indication: Convulsion
Norvasc
Dosage: oral
Administration route: Oral
Indication: Cardiac Disorder
Dilantin
Dosage: 600 mg (300 mg,2 in 1 d),oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Tylenol W / Codeine NO. 3
Dosage: (1 d)
Indication: Migraine
Simvastatin
Dosage: (40 mg,1 d),oral
Administration route: Oral
Indication: Blood Cholesterol Increased
Nitrostat
Dosage: (0.4 mg,as required)
Indication: Chest Pain
Lactulose
Dosage: (30 mg,as required)
Indication: Crohn's Disease
Zantac
Dosage: 900 mg (300 mg,3 in 1 d)
Indication: Gastrooesophageal Reflux Disease
Possible Lantus side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-04-05
Patient: 56 year old female
Reactions: Product Quality Issue, Pain in Extremity, Device Difficult To Use, Muscular Weakness, Joint Dislocation, Joint Crepitation, Limb Injury, Nodule, Asthenia
Drug(s) suspected as cause:
Solostar
Start date: 2011-01-01
End date: 2012-03-01
Lantus
Dosage: dose:60 unit(s)
Start date: 2011-01-01
End date: 2012-03-01
Other drugs received by patient: Apidra
Possible Lantus side effects in 74 year old male
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: 74 year old male, weighing 62.0 kg (136.4 pounds)
Reactions: Product Quality Issue, Fatigue, Syncope, Hyperglycaemia, Dizziness, Thirst
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Solostar
Indication: Type 2 Diabetes Mellitus
Start date: 2012-01-17
Lantus
Dosage: dose:15 unit(s)
Start date: 2012-02-01
Lantus
Dosage: dose:10 unit(s)
Indication: Type 2 Diabetes Mellitus
Start date: 2012-01-17
Other drugs received by patient: Crestor; Quinapril
Possible Lantus side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-03-14
Patient: 55 year old female
Reactions: Product Quality Issue, Bronchitis, Blood Glucose Increased, Loss of Consciousness, Influenza
Drug(s) suspected as cause:
Lantus
Dosage: dose:17 unit(s)
Indication: Type 2 Diabetes Mellitus
Start date: 2011-01-01
Solostar
Indication: Type 2 Diabetes Mellitus
Start date: 2011-01-01
Possible Lantus side effects in 46 year old male
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: 46 year old male
Reactions: Product Quality Issue, Hospitalisation, Expired Drug Administered, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:80 unit(s)
Start date: 2007-01-01
Apidra
Dosage: 60-70 units
Start date: 2007-01-01
Solostar
Start date: 2007-01-01
Apidra
Dosage: 60-70 units
Start date: 2007-01-01
Solostar
Start date: 2007-01-01
Possible Lantus side effects in 74 year old male
Reported by a consumer/non-health professional from United States on 2012-03-05
Patient: 74 year old male, weighing 62.0 kg (136.4 pounds)
Reactions: Product Quality Issue, Syncope, Fatigue, Hyperglycaemia, Dizziness, Thirst
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:10 unit(s)
Indication: Type 2 Diabetes Mellitus
Start date: 2012-01-17
Solostar
Indication: Type 2 Diabetes Mellitus
Start date: 2012-01-17
Lantus
Dosage: dose:15 unit(s)
Start date: 2012-02-01
Other drugs received by patient: Crestor; Quinapril
Possible Lantus side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2012-03-01
Patient: 71 year old female
Reactions: Product Quality Issue, Hypoglycaemia, Osteomyelitis, General Physical Health Deterioration, LEG Amputation, Bladder Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:35 unit(s)
Start date: 2002-01-01
Lantus
Dosage: dose:35 unit(s)
Start date: 2002-01-01
Other drugs received by patient: Humalog
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Product Quality Issue, Neuropathy Peripheral, Drug Ineffective, Abasia, Diabetic Coma, Transient Ischaemic Attack, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:14 unit(s)
Start date: 2011-10-12
Lantus
Dosage: dose:14 unit(s)
End date: 2011-10-11
Other drugs received by patient: Humalog
Possible Lantus side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2012-02-10
Patient: 77 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Product Quality Issue, Hypoglycaemia, Transient Ischaemic Attack, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin HCL
Solostar
Start date: 2011-08-01
Lantus
Dosage: dose:20 unit(s)
Glipizide
Possible Lantus side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-01-31
Patient: 63 year old female
Reactions: Product Quality Issue, Drug Dose Omission, Wrong Technique in Drug Usage Process, Pneumonia, Injection Site Haematoma, Device Difficult To Use, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Opticlick
Start date: 2010-01-01
Lantus
Dosage: 22-25units
Start date: 2010-01-01
Other drugs received by patient: Novolog
Possible Lantus side effects in 77 year old female
Reported by a consumer/non-health professional from United States on 2012-01-30
Patient: 77 year old female
Reactions: Product Quality Issue, Chest Pain, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Other drugs received by patient: Novolog
Possible Lantus side effects in 64 year old female
Reported by a consumer/non-health professional from United States on 2012-01-25
Patient: 64 year old female, weighing 73.0 kg (160.6 pounds)
Reactions: Vaginal Polyp, Product Quality Issue, Bladder Neoplasm, Hypoglycaemia, Sciatica, Hyperglycaemia, Cerebrovascular Accident, Blood Glucose Increased
Drug(s) suspected as cause:
Lantus
Other drugs received by patient: Calcitriol; Humalog; ALL Other Therapeutic Products; Timolol Maleate; Methenamine TAB; Loperamide; Allegra-D 12 Hour; ALL Other Therapeutic Products; Nitroglycerin
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-19
Patient: female
Reactions: Product Quality Issue, Atrial Fibrillation, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:24 unit(s)
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Solostar
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Possible Lantus side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-13
Patient: male
Reactions: Blood Glucose Decreased, Product Quality Issue, Wrong Drug Administered, Hypoglycaemia, Peripheral Arterial Occlusive Disease, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Insulin Detemir
Dosage: dose:50 unit(s)
Solostar
Start date: 2005-01-01
Lantus
Dosage: dose:50 unit(s)
Start date: 2005-01-01
Possible Lantus side effects in 55 year old male
Reported by a consumer/non-health professional from United States on 2012-01-13
Patient: 55 year old male, weighing 113.0 kg (248.6 pounds)
Reactions: Product Quality Issue, Drug Ineffective, Hypertension, Renal Mass, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Start date: 2010-03-14
Solostar
Start date: 2010-03-14
Other drugs received by patient: Metformin HCL; Vytorin
Possible Lantus side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-12
Patient: male, weighing 77.0 kg (169.4 pounds)
Reactions: Histoplasmosis, Product Quality Issue, Drug Ineffective, Blood Glucose Increased
Drug(s) suspected as cause:
Lantus
Dosage: dose:23 unit(s)
Start date: 2010-12-01
Lantus
Dosage: dose:22 unit(s)
Lantus
Dosage: dose:25 unit(s)
Solostar
Start date: 2010-01-01
Other drugs received by patient: Furosemide; Metoprolol; Accupril
Possible Lantus side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-04
Patient: male
Reactions: Pancreatic Disorder, Product Quality Issue, Injection Site Injury
Drug(s) suspected as cause:
Lantus
Dosage: dose:45 unit(s)
Start date: 2007-01-01
Solostar
Start date: 2007-01-01
Possible Lantus side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-01-04
Patient: 61 year old female
Reactions: Product Quality Issue, Renal Transplant, Medication Error, Tremor
Drug(s) suspected as cause:
Lantus
Dosage: dose:32 unit(s)
Indication: Type 2 Diabetes Mellitus
Start date: 2006-01-01
Solostar
Indication: Type 2 Diabetes Mellitus
Start date: 2006-01-01
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