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Lantus (Insulin Glargine) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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



Possible Lantus side effects in 61 year old female

Reported by a consumer/non-health professional from Mexico on 2012-08-23

Patient: 61 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Hyperglycaemia, Hypertension, Hepatic Cirrhosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus

Other drugs received by patient: Levothyroxine Sodium



Possible Lantus side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Weight Increased, Lung Disorder, Sciatica, Blood Glucose Increased

Drug(s) suspected as cause:
Lantus
    Dosage: dose:72 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: Macular Degeneration

Drug(s) suspected as cause:
Lantus
    Dosage: dose:30 unit(s)
    Start date: 2010-01-01

Solostar
    Start date: 2010-01-01



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

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