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Lantus (Insulin Glargine) - Side Effects & Adverse Reactions Reported to FDA

 



This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Lantus (Insulin Glargine). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.

Our database includes reports primarily from April 2009 to March 2010. The information is not vetted and should not be cosidered as verified clinical evidence.

All cases (2527)
     Device Malfunction (458)Blood Glucose Increased (368)Hypoglycaemia (187)more >>

Cases resulting in a serious event (2442)
     Device Malfunction (456)Blood Glucose Increased (340)Hypoglycaemia (184)more >>

Cases resulting in death (195)
     Fall (18)Cold Sweat (17)Haemorrhagic Stroke (16)more >>

Cases resulting in life threatening events (64)
     Hypoglycaemia (21)Unresponsive TO Stimuli (9)Drug Interaction (9)more >>

Cases resulting in hospitalization (832)
     Blood Glucose Increased (151)Hypoglycaemia (83)Hyperglycaemia (72)more >>

Cases resulting in disability (62)
     Oedema Peripheral (12)Pain in Extremity (11)Hypoglycaemia (7)more >>

Cases resulting in other serious reactions (1606)
     Device Malfunction (455)Blood Glucose Increased (228)Cataract (123)more >>

Below is a sample of reports where side effects / adverse reactions may be related to Lantus (Insulin Glargine). For a complete list and/or a specific selection of reports, please use the links in the index above.

Possible Lantus side effects / adverse reactions in 17 year old male

Reported by a physician from United Kingdom on 2010-03-31

Patient: 17 year old male

Reactions: Cerebral Venous Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Novorapid
    Dosage: unk
    Indication: Type 1 Diabetes Mellitus

Lantus
    Indication: Type 1 Diabetes Mellitus



Possible Lantus side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-03-31

Patient: female

Reactions: Device Malfunction

Suspect drug(s):
Solostar
    Indication: Insulin-Requiring Type 2 Diabetes Mellitus

Lantus
    Dosage: dose:80 unit(s)
    Indication: Insulin-Requiring Type 2 Diabetes Mellitus



Possible Lantus side effects / adverse reactions in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2010-03-31

Patient: 64 year old female

Reactions: Hypoglycaemia, Hyperhidrosis

Suspect drug(s):
Opticlick
    Indication: Diabetes Mellitus
    Start date: 2006-01-01

Lantus
    Dosage: dose:60 unit(s)
    Indication: Diabetes Mellitus
    Start date: 2006-01-01



Possible Lantus side effects / adverse reactions in

Reported by a pharmacist from United States on 2010-03-31

Patient:

Reactions: Device Malfunction

Suspect drug(s):
Solostar

Lantus



Possible Lantus side effects / adverse reactions in male

Reported by a consumer/non-health professional from United States on 2010-03-31

Patient: male

Reactions: Device Malfunction

Suspect drug(s):
Solostar

Lantus
    Dosage: dose:50 unit(s)
    Start date: 2005-05-01



Possible Lantus side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-03-31

Patient: female

Reactions: Device Malfunction

Suspect drug(s):
Solostar

Lantus



Possible Lantus side effects / adverse reactions in female

Reported by a physician from Italy on 2010-03-31

Patient: female

Reactions: Hypoglycaemia, Asthenia, Hypokalaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Novorapid Flexpen
    Dosage: 23 u, qd
    Indication: Diabetes Mellitus
    Start date: 2009-02-13

Lantus
    Dosage: 14 u, qd
    Indication: Diabetes Mellitus
    Start date: 2009-02-13

Metforal
    Dosage: 1500 mg, qd
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2009-02-13

Other drugs received by patient: Losazid



Possible Lantus side effects / adverse reactions in male

Reported by a consumer/non-health professional from United States on 2010-03-31

Patient: male

Reactions: Device Malfunction

Suspect drug(s):
Solostar

Lantus



Possible Lantus side effects / adverse reactions in 86 year old male

Reported by a consumer/non-health professional from Brazil on 2010-03-30

Patient: 86 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Bowel Movement Irregularity, Jaundice, Dyspnoea, Vomiting, Pancreatic Neoplasm, Diarrhoea, Dysuria, Septic Shock, Blood Glucose Increased, Infection, Infarction

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Lantus
    Indication: Type 2 Diabetes Mellitus
    End date: 2010-02-18

Optipen
    End date: 2010-02-18

Other drugs received by patient: Glucovance; Simvastatin; Cilostazol; NPH Insulin; Novorapid



Possible Lantus side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: female

Reactions: Confusional State, Somnolence, Convulsion, Speech Disorder, Blood Glucose Decreased, Tongue Biting, Altered State of Consciousness, Shock Hypoglycaemic

Suspect drug(s):
Novolog
    Dosage: 1 unit per 15 grams of carbohydrates
    Indication: Type 1 Diabetes Mellitus

Lantus
    Dosage: 25 iu, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-01-01



Possible Lantus side effects / adverse reactions in 62 year old male

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: 62 year old male

Reactions: Renal Function Test Abnormal, Dehydration, Blood Potassium Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Lantus
    Dosage: dose:20 unit(s)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-03-18

Solostar
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-03-18

Other drugs received by patient: Glucophage; Diuretics; Niaspan; Fenofibrate



Possible Lantus side effects / adverse reactions in male

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: male

Reactions: Drug Ineffective, Device Malfunction

Suspect drug(s):
Solostar

Lantus



Possible Lantus side effects / adverse reactions in 87 year old female

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: 87 year old female

Reactions: Cataract, Neuropathy Peripheral, Pneumonia, Retinal Disorder, Macular Degeneration

Suspect drug(s):
Lantus
    Dosage: dose:46 unit(s)
    Indication: Insulin-Requiring Type 2 Diabetes Mellitus

Opticlick
    Indication: Insulin-Requiring Type 2 Diabetes Mellitus



Possible Lantus side effects / adverse reactions in 78 year old female

Reported by a individual with unspecified qualification from France on 2010-03-30

Patient: 78 year old female

Reactions: Insulin-Requiring Type 2 Diabetes Mellitus, Anaemia, Atrial Fibrillation, Clostridium Difficile Colitis, Hyponatraemia, Cardiac Disorder, Gastritis, Hypokalaemia, Anxiety, Cardiac Failure, Dehydration, Oedema, Hypertension, Erysipelas, Renal Failure Acute

Adverse event resulted in: death

Suspect drug(s):
Levothyroxine Sodium
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d)
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 1993-01-01
    End date: 2009-10-27

Augmentin (Amoxicilline, Clavulanic Acid)
    Dosage: 1 g/day for 10 days per month
    Administration route: Oral
    Indication: Erysipelas
    Start date: 2009-08-04
    End date: 2009-10-07

Inexium (40 MG, Gastro-Resistant Tablet) (Esomeprazole Magnesium)
    Dosage: 1 dosgage forms (1 dosage forms, 1 in 1 d)
    Administration route: Oral
    Indication: Gastritis
    Start date: 2008-08-01
    End date: 2009-10-27

Previscan (20 MG, Tablet) (Pentoxifylline)
    Dosage: 5 mg (5 mg, 1 in 1 d)
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 1993-01-01
    End date: 2009-10-27

Ramipril
    Dosage: 7.5 mg (7.5 mg,1 in 1 d)
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-04-03
    End date: 2009-10-07

Cordarone
    Dosage: 200 mg 5/7 days
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 1994-11-01
    End date: 2009-10-27

Lasix
    Dosage: 80 mg (40 mg, 2 in 1 d)
    Indication: Oedema DUE TO Cardiac Disease
    Start date: 2008-01-01
    End date: 2009-10-07

Kaleorid LP (600 MG, Modified-Release Tablet) (Potassium Chloride)
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d)
    Administration route: Oral
    Indication: Hypokalaemia
    Start date: 2008-01-01
    End date: 2009-10-07

Folic Acid
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d)
    Administration route: Oral
    Indication: Anaemia
    End date: 2009-10-07

Dafalgan (500 MG, Capsule) (Paracetamol)
    Dosage: on request
    Administration route: Oral
    Indication: Analgesic Intervention Supportive Therapy
    Start date: 1990-01-01
    End date: 2009-10-07

Lorazepam
    Dosage: 1 dosage forms (1 dosage forms, 1 in 1 d)
    Administration route: Oral
    Indication: Anxiety
    Start date: 1991-01-01
    End date: 2009-10-07

Lantus
    Dosage: 22 iu (22 iu, 1 in 1 d)
    Indication: Insulin-Requiring Type 2 Diabetes Mellitus
    Start date: 2004-01-01
    End date: 2009-10-24



Possible Lantus side effects / adverse reactions in female

Reported by a consumer/non-health professional from South Africa on 2010-03-30

Patient: female

Reactions: Product Quality Issue, Device Malfunction

Suspect drug(s):
Solostar

Lantus



Possible Lantus side effects / adverse reactions in 84 year old male

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: 84 year old male

Reactions: Abdominal Pain, Rhabdomyolysis, Pneumonia, International Normalised Ratio Increased, Blood Pressure Decreased, Blood Glucose Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Lantus

Other drugs received by patient: Omeprazole; Metoprolol Tartrate



Possible Lantus side effects / adverse reactions in 81 year old male

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: 81 year old male

Reactions: Cataract

Suspect drug(s):
Lantus
    Dosage: dose:55 unit(s)
    Indication: Diabetes Mellitus

Apidra
    Dosage: per sliding scale 2-3 times per day

Opticlick
    Indication: Diabetes Mellitus

Opticlick



Possible Lantus side effects / adverse reactions in female

Reported by a consumer/non-health professional from Brazil on 2010-03-29

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Hyperglycaemia, Ketoacidosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Lantus
    Start date: 2009-05-01

Solostar
    Start date: 2009-05-01

Other drugs received by patient: Humalog; Puran T4



Possible Lantus side effects / adverse reactions in 56 year old female

Reported by a physician from Japan on 2010-03-29

Patient: 56 year old female, weighing 64.3 kg (141.5 pounds)

Reactions: Hepatic Function Abnormal

Adverse event resulted in: hospitalization

Suspect drug(s):
Lantus
    Dosage: dose:8 unit(s)
    Indication: Diabetes Mellitus
    End date: 2010-03-02

Solostar
    Indication: Hyperglycaemia
    End date: 2010-03-02

Other drugs received by patient: Mevalotin; Pioglitazone HCL; Miglitol; Flomox; Lorcam



Possible Lantus side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2010-03-29

Patient: 45 year old female

Reactions: Breast Cancer

Suspect drug(s):
Lantus
    Dosage: dose:20 unit(s)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-01-01

Opticlick
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-01-01



Possible Lantus side effects / adverse reactions in 42 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2010-03-29

Patient: 42 year old female

Reactions: Hyperglycaemia, Device Malfunction

Suspect drug(s):
Solostar
    Indication: Type 1 Diabetes Mellitus

Lantus
    Dosage: dose:26 unit(s)
    Indication: Type 1 Diabetes Mellitus

Other drugs received by patient: Humalog; ALL Other Therapeutic Products



Possible Lantus side effects / adverse reactions in 60 year old male

Reported by a consumer/non-health professional from United States on 2010-03-29

Patient: 60 year old male

Reactions: Blindness, Corrective Lens User

Suspect drug(s):
Lantus
    Dosage: dose:70 unit(s)
    Indication: Type 1 Diabetes Mellitus
    Start date: 2006-01-01

Solostar



Possible Lantus side effects / adverse reactions in 42 year old male

Reported by a consumer/non-health professional from United States on 2010-03-29

Patient: 42 year old male

Reactions: Heart Transplant

Suspect drug(s):
Lantus
    Dosage: dose:50 unit(s)
    Start date: 2005-05-01

Solostar



Possible Lantus side effects / adverse reactions in 13 year old female

Reported by a consumer/non-health professional from United States on 2010-03-29

Patient: 13 year old female

Reactions: Hyperglycaemia, Device Malfunction

Suspect drug(s):
Solostar
    Indication: Type 1 Diabetes Mellitus
    Start date: 2010-02-01

Lantus
    Dosage: dose:34 unit(s)
    Indication: Type 1 Diabetes Mellitus
    Start date: 2010-02-01



Possible Lantus side effects / adverse reactions in 72 year old male

Reported by a consumer/non-health professional from Brazil on 2010-03-29

Patient: 72 year old male, weighing 62.0 kg (136.4 pounds)

Reactions: Weight Decreased, Intestinal Polyp, Hyperglycaemia, Gastrointestinal Carcinoma

Suspect drug(s):
Lantus
    Indication: Type 2 Diabetes Mellitus
    Start date: 2006-04-01
    End date: 2007-01-01

Lantus
    Start date: 2007-01-01

Optipen
    Start date: 2006-04-01

Autopen 24

Puran T4
    Administration route: Oral
    Indication: Thyroid Disorder

Other drugs received by patient: Benerva

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