This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lantus (Insulin Glargine) 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 (2929)
Death (339)
Life Threatening Events (123)
Disability (142)
Reports by Reaction Type
Device Malfunction (462),
Blood Glucose Increased (396),
Product Quality Issue (272),
Hyperglycaemia (254),
Hypoglycaemia (240),
Cerebrovascular Accident (109),
Death (103),
Blood Glucose Decreased (101),
Fall (90),
Renal Failure (90),
Myocardial Infarction (88),
Weight Decreased (86)
Below are a few examples of reports where side effects / adverse reactions may be related to Lantus (Insulin Glargine). For a complete list or a specific selection of reports, please use the links above.
Possible Lantus side effects in male
Reported by a physician from South Africa on 2012-08-27
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lantus
Possible Lantus side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-27
Patient: 70 year old male, weighing 65.0 kg (143.0 pounds)
Reactions: Agitation, Hypoglycaemia, Schizophrenia, Somnolence, BED Rest, Hyperhidrosis, Dementia Alzheimer's Type, Depression, Hyperglycaemia, Micturition Urgency, Eating Disorder, Tremor, Hypopnoea, Impaired Healing, Respiratory Arrest, Diabetic Retinopathy, Feeling Abnormal, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: started about 8 years ago
Lantus
Solostar
Dosage: started about 8 years ago
Possible Lantus side effects in 73 year old male
Reported by a consumer/non-health professional from Mexico on 2012-08-27
Patient: 73 year old male
Reactions: Unevaluable Event
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lantus
Other drugs received by patient: Levothyroxine Sodium
Possible Lantus side effects in 49 year old female
Reported by a physician from United States on 2012-08-27
Patient: 49 year old female, weighing 69.9 kg (153.8 pounds)
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Insulin Lispro
Dosage: dose:37 unit(s)
Start date: 2011-10-11
Lantus
Dosage: dose:25 unit(s)
Start date: 2011-10-11
Other drugs received by patient: Coreg; Lipitor; Furosemide
Possible Lantus side effects in 62 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: 62 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Blood Glucose Decreased, Dizziness, Vision Blurred, Osteopenia, Cardiac Disorder, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Autopen 24
Indication: Device Therapy
Start date: 2002-01-01
Lantus
Dosage: dose: 40 iu in the morning and 10 iu at night.
Indication: Type 1 Diabetes Mellitus
Start date: 2002-01-01
Other drugs received by patient: Atorvastatin; Diovan; Novorapid; Metformin; Aspirin; Atenolol; Omeprazole; Amlodipine
Possible Lantus side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 61 year old male
Reactions: Cardiac Disorder
Drug(s) suspected as cause:
Lantus
Dosage: dose increased to 70 units after the heart surgery.
Start date: 2012-01-01
Lantus
Dosage: dose increased to 70 units after the heart surgery.
Start date: 2012-01-01
Solostar
Start date: 2012-01-01
Solostar
Start date: 2012-01-01
Possible Lantus side effects in 65 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-24
Patient: 65 year old female, weighing 76.0 kg (167.2 pounds)
Reactions: Injection Site Haematoma, Injection Site Haemorrhage, Hyperglycaemia, Injection Site Pain, Cerebrovascular Accident, Injection Site Reaction, Dizziness, Arterial Occlusive Disease, Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Other drugs received by patient: Olanzapine; Enalapril Maleate; Aspirin; Bisoprolol Fumarate; Rosuvastatin; Folic Acid; Clonazepam; Fluoxetine HCL; Bisoprolol Fumarate; Isosorbide Mononitrate
Possible Lantus side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 60 year old female
Reactions: Cerebrovascular Accident, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: 15 - 18 units twice daily.
Indication: Type 2 Diabetes Mellitus
Start date: 2012-07-01
Novolog
End date: 2012-01-01
Solostar
Start date: 2012-07-01
Possible Lantus side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 62 year old female
Reactions: Haemoptysis, Visual Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:6 unit(s)
Solostar
Possible Lantus side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Aspirin
Dosage: 81 mg, prn
Indication: Chest Pain
Atenolol
Dosage: 25 mg, qd
Administration route: Oral
Indication: Hypertension
Ativan
Dosage: 1 mg, tid
Administration route: Oral
Indication: Nervousness
Atropine Sulfate
Dosage: 2.5 mg, qid
Administration route: Oral
Indication: Crohn's Disease
Depakote
Dosage: 500 mg, bid
Administration route: Oral
Indication: Convulsion
Dilantin
Dosage: 300 mg, bid
Administration route: Oral
Indication: Convulsion
Furosemide
Dosage: 40 mg, bid
Administration route: Oral
Indication: Diuretic Therapy
Generlac
Dosage: 30 mg, prn
Indication: Crohn's Disease
Humulin R
Dosage: 24 units
Indication: Diabetes Mellitus
Imdur
Dosage: 30 mg, tid
Indication: Cardiac Disorder
Lantus
Dosage: 80 units in the moring and 90 units at night
Indication: Diabetes Mellitus
Lantus
Dosage: unk
Methocarbamol
Indication: Neuropathy Peripheral
Methocarbamol
Dosage: 750 mg, prn
Administration route: Oral
Indication: Muscle Spasms
Nitrostat
Dosage: 0.4 mg, prn
Indication: Chest Pain
Norvasc
Administration route: Oral
Indication: Palpitations
Potassium Chloride
Potassium Chloride (KV / 24)
Dosage: 8 meq, qd
Indication: Blood Potassium
Remeron
Dosage: 30 mg, qd
Administration route: Oral
Indication: Insomnia
Tylenol
Dosage: unk unk, qd
Indication: Migraine
Zantac
Dosage: 30 mg, tid
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Zocor
Dosage: 40 mg, qd
Administration route: Oral
Possible Lantus side effects in 60 year old male
Reported by a consumer/non-health professional from Egypt on 2012-08-23
Patient: 60 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lantus
Possible Lantus side effects in 66 year old female
Reported by a pharmacist from United States on 2012-08-23
Patient: 66 year old female
Reactions: Fluid Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:70 unit(s)
Lantus
Dosage: 10 units in am 5 units in pm
Indication: Type 2 Diabetes Mellitus
Solostar
Indication: Type 2 Diabetes Mellitus
Possible Lantus side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lantus
Solostar
Possible Lantus side effects in 59 year old male
Reported by a consumer/non-health professional from Egypt on 2012-08-23
Patient: 59 year old male
Reactions: Pancreatic Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Lantus
Possible Lantus side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 68 year old female
Reactions: Atrial Flutter, Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:25 unit(s)
Indication: Type 2 Diabetes Mellitus
Solostar
Indication: Type 2 Diabetes Mellitus
Possible Lantus side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male
Reactions: Coronary Artery Bypass
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Solostar
Possible Lantus side effects in
Reported by a physician from France on 2012-08-23
Patient:
Reactions: Death, Neoplasm
Adverse event resulted in: death
Drug(s) suspected as cause:
Diamicron
Dosage: 30 mg, qd
Administration route: Oral
Start date: 2011-09-23
End date: 2012-01-16
Januvia
Dosage: 100 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-09-23
End date: 2012-01-16
Lantus
Lantus
Dosage: 32 iu, qd
Indication: Type 2 Diabetes Mellitus
Start date: 2011-09-23
End date: 2012-01-16
Metformin HCL
Dosage: 700 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-09-23
End date: 2012-01-16
Metformin HCL
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2010-02-01
End date: 2011-09-23
Metformin Hydrochloride
Dosage: 2 df, qd
Administration route: Oral
Start date: 2011-01-16
Metformin Hydrochloride
Dosage: 2 df, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2010-09-29
End date: 2011-09-23
Repaglinide
Dosage: 6 mg, qd
Administration route: Oral
Start date: 2012-01-16
Repaglinide
Dosage: 12 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2010-05-28
End date: 2011-09-23
Sitagliptin Phosphate / Metformin Hydrochloride
Dosage: 2 df, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2010-02-01
End date: 2010-09-29
Possible Lantus side effects in 61 year old female
Reported by a physician from Argentina on 2012-08-23
Patient: 61 year old female
Reactions: Uterine Cancer, Haemorrhage, Drug Administration Error, Ovarian Cancer
Drug(s) suspected as cause:
Apidra
Dosage: dose:4 unit(s)
Indication: Type 2 Diabetes Mellitus
Start date: 2012-07-01
Lantus
Dosage: dose: 40 units in the morning and 15 units in the afternoon
Indication: Type 2 Diabetes Mellitus
Start date: 2012-07-01
Other drugs received by patient: Novolog MIX 70 / 30
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: Limb Injury, Rotator Cuff Syndrome, Blood Glucose Increased
Drug(s) suspected as cause:
Humalog
Lantus
Dosage: dose:24 unit(s)
Start date: 2007-01-01
Solostar
Start date: 2007-01-01
Possible Lantus side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lantus
Possible Lantus side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Injection Site Pain, Blood Glucose Increased
Drug(s) suspected as cause:
Januvia
Dosage: 100 mg, qam
Lantus
Dosage: 40 iu, qam
Possible Lantus side effects in 57 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-23
Patient: 57 year old female, weighing 57.0 kg (125.4 pounds)
Reactions: Thrombosis, Nausea, Pain, Hyperglycaemia, Headache, Angiopathy
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lantus
Other drugs received by patient: Metformin; Bromazepam; Glyburide; Insulins and Analogues,fast-Acting; Captopril
Possible Lantus side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 65 year old female
Reactions: Colon Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Dosage: dose:52 unit(s)
Solostar
Possible Lantus side effects in 76 year old female
Reported by a consumer/non-health professional from South Africa on 2012-08-23
Patient: 76 year old female
Reactions: Respiratory Tract Infection, Blood Glucose Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Glamaryl
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Glucophage
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Lantus
Indication: Type 2 Diabetes Mellitus
End date: 2012-07-16
Possible Lantus side effects in 69 year old female
Reported by a consumer/non-health professional from NEW Zealand on 2012-08-23
Patient: 69 year old female
Reactions: Vomiting, Chest Discomfort, Haemoptysis, Nausea, Atrial Fibrillation, Abdominal Tenderness, Abdominal Pain Upper, Palpitations, Diarrhoea, Heart Rate Increased, Gastrointestinal Disorder, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Start date: 2011-11-30
Lantus
Dosage: dose:60 unit(s)
Lantus
Dosage: dose:12 unit(s)
Start date: 2012-06-24
Other drugs received by patient: Novorapid; Gabapentin; Furosemide; Acetaminophen; Metformin; Warfarin Sodium; Cilazapril; Levothyroxine Sodium; Simvastatin; Spironolactone; Digoxin; Metoprolol Tartrate; Aspirin
Possible Lantus side effects in 42 year old female
Reported by a consumer/non-health professional from South Africa on 2012-08-23
Patient: 42 year old female
Reactions: Localised Infection, TOE Amputation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lantus
Start date: 2012-01-27
End date: 2012-05-22
Solostar
Indication: Device Therapy
Start date: 2012-01-27
Possible Lantus side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: Retinal Detachment
Drug(s) suspected as cause:
Lantus
Dosage: dose:30 unit(s)
Indication: Diabetes Mellitus
Solostar
Indication: Diabetes Mellitus
Possible Lantus side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 61 year old male
Reactions: Cardiac Disorder
Drug(s) suspected as cause:
Lantus
Dosage: dose increased to 70 units after the heart surgery.
Start date: 2012-01-01
Lantus
Dosage: dose increased to 70 units after the heart surgery.
Start date: 2012-01-01
Solostar
Start date: 2012-01-01
Solostar
Start date: 2012-01-01
Possible Lantus side effects in 78 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 78 year old male
Reactions: Death, Cardiac Failure Congestive, Fluid Retention
Adverse event resulted in: death
Drug(s) suspected as cause:
Humulin 70 / 30
Lantus
Dosage: dose:20 unit(s)
End date: 2012-08-09
Possible Lantus side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 67 year old female
Reactions: Limb Operation, Headache, Tooth Disorder
Drug(s) suspected as cause:
Lantus
Dosage: dose:40 unit(s)
Start date: 2000-01-01
Novolog
Solostar
Start date: 2000-01-01
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