This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Apidra (Insulin Glulisine) 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 (354)
Death (7)
Life Threatening Events (15)
Disability (9)
Reports by Reaction Type
Blood Glucose Increased (77),
Product Quality Issue (36),
Hypoglycaemia (34),
Hyperglycaemia (26),
Blood Glucose Decreased (22),
Visual Impairment (22),
Diabetic Ketoacidosis (21),
Malaise (17),
Confusional State (16),
Drug Ineffective (16),
Weight Decreased (14),
Dizziness (14)
Below are a few examples of reports where side effects / adverse reactions may be related to Apidra (Insulin Glulisine). For a complete list or a specific selection of reports, please use the links above.
Possible Apidra side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 63 year old female, weighing 57.2 kg (125.7 pounds)
Reactions: Drug Effect Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Apidra
Dosage: 0-8 units per injection am, lunch, pm epidural
Indication: Type 1 Diabetes Mellitus
Start date: 2012-04-03
End date: 2012-08-23
Apidra
Dosage: 0-8 units per injection am, lunch, pm epidural
Indication: Type 1 Diabetes Mellitus
Start date: 2012-08-01
End date: 2012-08-23
Possible Apidra 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 Apidra side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 65 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Apidra
Dosage: dose:42 unit(s)
Start date: 2011-04-01
Lantus
Dosage: dose:80 unit(s)
Start date: 2011-04-01
Possible Apidra side effects in 58 year old female
Reported by a physician from Japan on 2012-08-21
Patient: 58 year old female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: female
Reactions: Hypersensitivity, Dyspnoea, Drug Ineffective, Urinary Tract Infection, Hyperglycaemia, Rash, Ketosis, Hyperglycaemic Seizure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in 61 year old female
Reported by a consumer/non-health professional from Argentina on 2012-08-13
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
Lantus
Dosage: bid 40 units in the morning and 15units in the afternoon
Indication: Type 2 Diabetes Mellitus
Possible Apidra side effects in 34 year old female
Reported by a physician from Czech Republic on 2012-08-13
Patient: 34 year old female
Reactions: Maternal Exposure During Pregnancy, Polyhydramnios
Drug(s) suspected as cause:
Apidra
Lantus
Possible Apidra side effects in 31 year old male
Reported by a physician from Germany on 2012-08-09
Patient: 31 year old male, weighing 130.0 kg (286.0 pounds)
Reactions: Diabetic Neuropathy, Diabetic Nephropathy
Drug(s) suspected as cause:
Apidra
Dosage: initial dose 20-8-12 iu, increased to 28-12-20 iu during the following 12 weeks
Start date: 2011-09-08
Lantus
Dosage: initial dose 30 iu, increased to 34 iu during the following 12 weeks
Start date: 2011-09-08
Other drugs received by patient: Other Lipid Modifying Agents
Possible Apidra side effects in 90 year old female
Reported by a consumer/non-health professional from Greece on 2012-08-07
Patient: 90 year old female
Reactions: Chills, Intentional Drug Misuse, Hyperhidrosis
Drug(s) suspected as cause:
Apidra
Apidra
Lantus Solostar
Solostar
Possible Apidra side effects in 17 year old male
Reported by a physician from India on 2012-08-07
Patient: 17 year old male, weighing 65.0 kg (143.0 pounds)
Reactions: Drug Ineffective, Diabetic Ketoacidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 67 year old female, weighing 84.5 kg (186.0 pounds)
Reactions: Pulmonary Embolism, Blood Glucose Fluctuation, Lower Limb Fracture, Urethritis, Coagulation Time Prolonged, Pyelonephritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Dosage: 6 units with breakfast in am, 6 units with lunch and 6 units with dinner
Lantus
Dosage: 24 u in am and 28 u in pmi
Start date: 2009-01-01
Solostar
Other drugs received by patient: Warfarin; Levothyroxine Sodium; Ramipril; Crestor; Lorazepam
Possible Apidra side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 31 year old female
Reactions: Diabetic Ketoacidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in
Reported by a physician from Czech Republic on 2012-07-31
Patient:
Reactions: Macrosomia, Premature Baby, Congenital Anomaly, Hypotonia, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Apidra
Lantus
Possible Apidra side effects in 34 year old female
Reported by a physician from Czech Republic on 2012-07-31
Patient: 34 year old female
Reactions: Maternal Exposure During Pregnancy, Polyhydramnios
Drug(s) suspected as cause:
Apidra
Lantus
Possible Apidra side effects in 58 year old female
Reported by a physician from Japan on 2012-07-26
Patient: 58 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in 66 year old female
Reported by a physician from Germany on 2012-07-25
Patient: 66 year old female, weighing 86.0 kg (189.2 pounds)
Reactions: Wrong Drug Administered, Hypoglycaemia, General Physical Health Deterioration, Hyperhidrosis, Tremor
Drug(s) suspected as cause:
Apidra
Indication: Type 2 Diabetes Mellitus
Start date: 2008-06-01
Lantus
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Solostar
Solostar
Possible Apidra side effects in female
Reported by a physician from Japan on 2012-07-25
Patient: female
Reactions: Renal Impairment
Drug(s) suspected as cause:
Apidra
Other drugs received by patient: Transamine CAP; Crestor; Lasix; Olmesartan Medoxomil; Loxoprofen; Celestamine TAB; Valsartan and Hydrochlorothiazide; Banan; Lantus; Allegra
Possible Apidra side effects in 31 year old male
Reported by a physician from Germany on 2012-07-20
Patient: 31 year old male, weighing 130.0 kg (286.0 pounds)
Reactions: Diabetic Neuropathy, Diabetic Nephropathy
Drug(s) suspected as cause:
Apidra
Dosage: initial dose 20-8-12 iu, increased to 28-12-20 iu during the following 12 weeks
Start date: 2011-09-08
Lantus
Dosage: initial dose 30 iu, increased to 34 iu during the following 12 weeks
Start date: 2011-09-08
Other drugs received by patient: Other Lipid Modifying Agents
Possible Apidra side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: 55 year old female, weighing 127.0 kg (279.4 pounds)
Reactions: Pain, Headache, Fall, Fatigue, Blood Glucose Increased, Dyspnoea, Paraesthesia, Tremor, Affective Disorder, Syncope, Insomnia, Heart Rate Increased, Electrocardiogram Abnormal, Disturbance in Attention, Gait Disturbance, Memory Impairment
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-18
Patient: male
Reactions: Hypotension, Hypoglycaemia, Bradykinesia, Sopor, Bradyphrenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Apidra
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Depakene
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Duloxetine Hydrochloride
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Humalog
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Lyrica
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Tramadol HCL
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Valium
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Other drugs received by patient: Ramipril
Possible Apidra side effects in 66 year old female
Reported by a physician from Germany on 2012-07-17
Patient: 66 year old female, weighing 86.0 kg (189.2 pounds)
Reactions: General Physical Health Deterioration
Drug(s) suspected as cause:
Apidra
Indication: Type 2 Diabetes Mellitus
Start date: 2008-06-01
Lantus
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Possible Apidra side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: 47 year old female
Reactions: Chest Pain, Unevaluable Event, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Lantus
Possible Apidra side effects in female
Reported by a physician from Japan on 2012-07-11
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Apidra
Possible Apidra side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-07-10
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Dyspnoea, Pneumonia, Labyrinthitis, Femur Fracture, Upper Limb Fracture, Bronchopneumonia, Abasia, Fall, Diarrhoea, Dizziness, Asthenia, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Dosage: dose: according to glycemic control
Start date: 2007-01-01
Lantus
Start date: 2007-01-01
Solostar
Indication: Device Therapy
Start date: 2007-01-01
Other drugs received by patient: Indapamide
Possible Apidra side effects in 40 year old male
Reported by a physician from Italy on 2012-07-10
Patient: 40 year old male
Reactions: Hypotension, Hypoglycaemia, Suicide Attempt, Bradykinesia, Bradyphrenia, Somnolence
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Apidra
Dosage: 3 ml, total
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Duloxetine Hydrochloride
Dosage: 56 iu, total
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Humalog
Dosage: 3 mg, total
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Lyrica
Dosage: 300 mg, 2x/day
Administration route: Oral
Indication: Diabetic Neuropathy
Lyrica
Dosage: 14 iu total
Administration route: Oral
Start date: 2012-05-23
End date: 2012-05-23
Tramadol HCL
Dosage: 30 ml
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Valium
Dosage: 20 ml, total
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Valproate Sodium
Dosage: 60 iu, total
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Other drugs received by patient: Ramipril
Possible Apidra side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-09
Patient: male
Reactions: Hypokinesia, Intentional Overdose, Hypoglycaemia, Hypotension, Suicide Attempt, Sopor
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Apidra
Dosage: 100 iu/milliltre, 3 milliliters once
Indication: Type 1 Diabetes Mellitus
Start date: 2012-05-23
End date: 2012-05-23
Apidra
Indication: Suicide Attempt
Depakene
Dosage: once
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Duloxetime Hydrochloride
Indication: Suicide Attempt
Duloxetime Hydrochloride
Dosage: once
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-23
End date: 2012-05-23
Humalog
Dosage: once
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Lyrica
Dosage: once
Administration route: Oral
Indication: Diabetic Neuropathy
Start date: 2012-05-23
End date: 2012-05-23
Lyrica
Indication: Suicide Attempt
Optiset
Dosage: 3 times a day, once
Indication: Device Therapy
Start date: 2012-05-23
End date: 2012-05-23
Tramadol HCL
Dosage: once
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Valium
Dosage: once
Administration route: Oral
Indication: Suicide Attempt
Start date: 2012-05-23
End date: 2012-05-23
Other drugs received by patient: Ramipril; Lantus
Possible Apidra side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-07-09
Patient: male, weighing 71.0 kg (156.2 pounds)
Reactions: Injection Site Inflammation, Lipodystrophy Acquired, Injection Site Infection, Injection Site Nodule
Drug(s) suspected as cause:
Apidra
Other drugs received by patient: Device NOS; Device NOS
Possible Apidra side effects in 87 year old female
Reported by a physician from Japan on 2012-07-02
Patient: 87 year old female
Reactions: Aortic Valve Stenosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Apidra
Other drugs received by patient: Olmesartan Medoxomil; Lipitor; Amlodipine; Lantus; Alendronate Sodium; Lantus; Calblock; Aspirin; Warfarin Sodium
Possible Apidra side effects in 79 year old female
Reported by a consumer/non-health professional from Brazil on 2012-06-29
Patient: 79 year old female, weighing 71.0 kg (156.2 pounds)
Reactions: Pain in Extremity, Hypoglycaemia, Osteoarthritis, Anxiety, Renal Failure, Visual Impairment, Hypertension, Feeling Abnormal, Nervousness, Inflammation
Drug(s) suspected as cause:
Apidra
Dosage: dose and frequency-20 iu daily divided in 5 doses, strength- 3ml cartridge
Start date: 2005-01-01
Clikstar
Indication: Device Therapy
Start date: 2005-01-01
Clikstar
Dosage: 5 times a day
Start date: 2005-01-01
Clonazepam
Dosage: 3-4 drops daily before sleep
Administration route: Oral
Indication: Insomnia
Lantus
Dosage: dose-24 to 26 iu daily at morning, strength- 3ml cartridge
Start date: 2005-01-01
Other drugs received by patient: Luftal; Apresoline; Benicar; Diovan; Atenolol; Simvastatin; Folic Acid; Atensine; Omeprazole; OS-CAL D; Levothyroxine Sodium; Epogen; Cilostazol; Lorazepam
Possible Apidra side effects in 10 year old female
Reported by a physician from Chile on 2012-06-27
Patient: 10 year old female, weighing 30.0 kg (66.0 pounds)
Reactions: Conduct Disorder, Psychomotor Hyperactivity, Hypoglycaemic Seizure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apidra
Dosage: dose: 0.76 u/kg
Start date: 2010-01-01
Apidra
Dosage: dose: 0.5-0.7 units not specified
Lantus
Start date: 2010-01-01
Lantus
Other drugs received by patient: Insulin
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