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Humalog (Insulin Lispro) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Humalog (Insulin Lispro) 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 (1211)
Death (72)
Life Threatening Events (57)
Disability (62)

Reports by Reaction Type

Blood Glucose Increased (353)Hypoglycaemia (128)Drug Ineffective (122)Blood Glucose Decreased (99)Hospitalisation (97)Incorrect Dose Administered (74)Drug Dose Omission (67)Hyperglycaemia (62)Malaise (61)Blindness (60)Fall (55)Cerebrovascular Accident (50)

Below are a few examples of reports where side effects / adverse reactions may be related to Humalog (Insulin Lispro). For a complete list or a specific selection of reports, please use the links above.

Possible Humalog side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Lantus



Possible Humalog side effects in female

Reported by a physician from Mexico on 2012-08-27

Patient: female, weighing 73.9 kg (162.6 pounds)

Reactions: Chorea, Hypoglycaemia, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Telmisartan; Verapamilo; Clortalidona; Aspirin; Omeprazole; Metformin; Dulaglutide



Possible Humalog side effects in female

Reported by a physician from Brazil on 2012-08-27

Patient: female, weighing 91.0 kg (200.2 pounds)

Reactions: Hypoglycaemia, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: unk, unknown

Humalog
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-05-25

Other drugs received by patient: Aspirin; Drug Used IN Diabetes; Metformin



Possible Humalog side effects in male

Reported by a physician from Brazil on 2012-08-27

Patient: male, weighing 96.0 kg (211.2 pounds)

Reactions: Hypoglycaemia, Fall, Loss of Consciousness

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Lantus; Captopril; Ciprofloxacin HCL



Possible Humalog side effects in male

Reported by a physician from Brazil on 2012-08-27

Patient: male, weighing 80.7 kg (177.5 pounds)

Reactions: Back Pain, Pneumonia, Sternal Fracture, Hypoglycaemia, Lung Neoplasm, Renal Cyst, Fall, Neck Pain, Pleural Effusion, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: 30 iu, unknown

Humalog
    Dosage: unk, unknown
    Indication: Diabetes Mellitus
    Start date: 2011-04-19

Humalog
    Dosage: 18 iu, unknown

Humalog
    Dosage: 27 iu, unknown

Other drugs received by patient: Captopril; Simvastatin; Propranolol; Hydrochlorothiazide



Possible Humalog side effects in 22 year old male

Reported by a consumer/non-health professional from Mexico on 2012-08-24

Patient: 22 year old male

Reactions: Gastrointestinal Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: unk
    Start date: 2008-01-01

Humulin N
    Dosage: unk
    Start date: 2008-01-01



Possible Humalog side effects in female

Reported by a physician from Germany on 2012-08-24

Patient: female

Reactions: Hyperglycaemia, Incorrect Dose Administered

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in 84 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 84 year old male

Reactions: Hospitalisation, Choking, Depressed Level of Consciousness, Bladder Catheterisation, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Insulin; Lantus



Possible Humalog side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Confusional State, Delirium

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Glipizde; Lantus



Possible Humalog side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 57 year old female, weighing 109.8 kg (241.5 pounds)

Reactions: Blood Glucose Increased, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: 30 u, qd
    Indication: Diabetes Mellitus
    Start date: 2012-01-01

Levemir
    Dosage: 30 u, qd
    Indication: Diabetes Mellitus
    Start date: 2012-01-01

Other drugs received by patient: Diovan; Amlodipine Besylate; Lipitor



Possible Humalog side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Pneumonia, Dyspnoea, Anaemia, Parkinson's Disease, Renal Failure, Neuropathy Peripheral, Oedema Peripheral, Blood Cholesterol Increased, Depression, Myocardial Infarction, Hypertension, Muscle Spasms, Fluid Retention

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Humalog
    Dosage: unk unk, prn
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-01-01

Humulin N
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-01-01
    End date: 2012-04-01

Other drugs received by patient: Potassium; Lantus



Possible Humalog side effects in 45 year old female

Reported by a consumer/non-health professional from South Africa on 2012-08-24

Patient: 45 year old female

Reactions: Uterine Mass

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: 10 u, tid
    Indication: Diabetes Mellitus
    Start date: 2012-03-21

Humulin N
    Dosage: 18 u, each evening
    Indication: Diabetes Mellitus
    Start date: 2012-03-21

Other drugs received by patient: Glucophage



Possible Humalog side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Oral Fungal Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Antibiotics



Possible Humalog side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Ill-Defined Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Lantus



Possible Humalog side effects in male

Reported by a consumer/non-health professional from Italy on 2012-08-24

Patient: male

Reactions: Cachexia, Haemoglobin Decreased, Vomiting, RED Blood Cell Count Decreased, Hypoglycaemia, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Lansoprazole; Aspirin



Possible Humalog side effects in 66 year old female

Reported by a consumer/non-health professional from France on 2012-08-24

Patient: 66 year old female

Reactions: Pancreatitis Acute, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Methotrexate Sodium; Prednisone TAB; Atorvastatin; Hydrea; Lasix; Nexium; Actonel; Lorazepam; Augmentin '125'; Rifadin; Xyzal; Spironolactone; Lamisil; Cefotaxime Sodium; Calciparine; Amitriptyline Hydrochloride; Clarithromycin



Possible Humalog side effects in female

Reported by a physician from Argentina on 2012-08-24

Patient: female, weighing 83.5 kg (183.7 pounds)

Reactions: Diabetic Ketoacidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dulaglutide
    Dosage: unk, weekly (1/w)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-06-23
    End date: 2011-06-28

Humalog
    Dosage: 6 iu, tid
    Start date: 2011-06-23
    End date: 2011-06-29

Humalog
    Dosage: 7 iu, tid
    Start date: 2011-06-01
    End date: 2011-06-29

Other drugs received by patient: Levothyroxine Sodium; Metformin HCL; Ranitidine; Tofranil; Enalapril Maleate; Clonazepam



Possible Humalog side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-24

Patient: male

Reactions: Renal Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Diuretics; Humulin N; Humulin N



Possible Humalog side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Glycosylated Haemoglobin Increased, Hypoglycaemia, Blood Triglycerides Increased, LOW Density Lipoprotein Increased, Blood Glucose Increased

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in 41 year old female

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

Patient: 41 year old female

Reactions: Glycosylated Haemoglobin Increased, Hypoglycaemia, Blood Glucose Increased

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Skin Ulcer, Hypoglycaemia, Wrong Drug Administered, Intentional Drug Misuse, Infected Skin Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-11-01

Humalog MIX 75 / 25
    Dosage: unk

Other drugs received by patient: Lantus



Possible Humalog side effects in female

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

Patient: female

Reactions: Hypertension, Arthritis, Cardiac Disorder

Drug(s) suspected as cause:
Humalog

Other drugs received by patient: Lisinopril; Celebrex; Lantus



Possible Humalog side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in 58 year old male

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

Patient: 58 year old male

Reactions: Renal Impairment, Hypoglycaemia, Hypertension, Blood Glucose Increased

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Head Injury, Laceration, Fall, Somnolence, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: unk unk, prn
    Indication: Diabetes Mellitus
    Start date: 2012-01-01

Humalog
    Dosage: unk unk, prn
    Start date: 2012-01-01



Possible Humalog 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 Humalog side effects in 27 year old female

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

Patient: 27 year old female

Reactions: Glycosylated Haemoglobin Increased, Hypoglycaemia, Blood Glucose Increased

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in female

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

Patient: female

Reactions: Nonspecific Reaction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Humalog



Possible Humalog side effects in male

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

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Humalog
    Dosage: 15 u, qd
    Indication: Diabetes Mellitus

Regular Iletin 2
    Dosage: unk, unknown



Possible Humalog side effects in 52 year old female

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

Patient: 52 year old female

Reactions: Contusion, Feeling Hot, Wound, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: 30 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-03-01

Humalog
    Dosage: 32 u, qd

Humalog
    Dosage: 5 u, qd

Other drugs received by patient: Acetaminophen; Lantus; Losartan Potassium; Lyrica; Tramadol HCL; Hydrochlorothiazide; Humulin N

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