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Humulin R (Insulin Human Subcutaneous) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Humulin R (Insulin Human Subcutaneous) 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 (339)
Death (19)
Life Threatening Events (12)
Disability (45)

Reports by Reaction Type

Blood Glucose Increased (109)Drug Ineffective (58)Blood Glucose Decreased (45)Hypoglycaemia (33)Chronic Obstructive Pulmonary Disease (25)Hospitalisation (24)Emphysema (23)Amnesia (22)Bedridden (20)Fall (20)Incorrect Dose Administered (18)Weight Decreased (17)

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

Possible Humulin R side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 48 year old male

Reactions: Blood Glucose Decreased, Drug Ineffective, Incorrect Dose Administered, Biopsy Lung, Blood Glucose Increased, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin 70 / 30
    Dosage: unk unk, prn
    Indication: Diabetes Mellitus

Humulin N
    Dosage: unk, prn
    Indication: Diabetes Mellitus

Humulin R
    Dosage: unk, prn
    Indication: Diabetes Mellitus



Possible Humulin R side effects in 65 year old male

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient: 65 year old male

Reactions: Intentional Overdose, Hypoglycaemic Encephalopathy, Hypoglycaemic Coma, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin R

Humulin R
    Indication: Diabetes Mellitus



Possible Humulin R side effects in male

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

Patient: male

Reactions: Neoplasm Malignant, Scab, Urticaria, Skin Haemorrhage, Expired Drug Administered, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin R

Other drugs received by patient: Lipid Modifying Agents; Cardiac Therapy; Antihypertensives



Possible Humulin R side effects in 41 year old female

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

Patient: 41 year old female, weighing 90.0 kg (198.0 pounds)

Reactions: Gastrectomy, Drug Dispensing Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin N
    Dosage: 50 u, unknown
    Indication: Diabetes Mellitus
    Start date: 2008-01-01

Humulin R
    Dosage: unk, unknown



Possible Humulin R side effects in female

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

Patient: female

Reactions: Dysphagia, Hiatus Hernia, Wrong Drug Administered, Visual Acuity Reduced, Cerebrovascular Accident, Herpes Zoster, Convulsion, Speech Disorder, Hypoaesthesia Oral, Neuropathy Peripheral, Choking, Memory Impairment, Hemiplegia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Humulin N
    Dosage: unk, unknown
    Indication: Diabetes Mellitus

Humulin R
    Dosage: unk unk, prn
    Indication: Diabetes Mellitus



Possible Humulin R side effects in male

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

Patient: male

Reactions: Arterial Thrombosis, Fatigue, Stent Placement, Chest Pain, Pulmonary Thrombosis, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin N
    Dosage: unk, unknown
    Indication: Diabetes Mellitus
    Start date: 2002-03-16

Humulin N
    Dosage: 60 u, unk

Humulin R
    Dosage: 35 u, prn

Humulin R
    Dosage: unk, unknown
    Indication: Diabetes Mellitus
    Start date: 2002-03-16



Possible Humulin R 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 Humulin R side effects in female

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

Patient: female

Reactions: Blood Pressure Increased, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin R

Other drugs received by patient: Glipizide



Possible Humulin R side effects in 56 year old male

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

Patient: 56 year old male

Reactions: Renal Disorder, Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin R



Possible Humulin R side effects in male

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

Patient: male

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Humulin N
    Dosage: unk, unknown
    Indication: Diabetes Mellitus

Humulin R
    Dosage: unk, unknown
    Indication: Diabetes Mellitus



Possible Humulin R side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Hospitalisation, Drug Ineffective, Incorrect Dose Administered, Blindness, Cardiac Disorder, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Indication: Diabetes Mellitus

Humulin R
    Dosage: unk unk, tid
    Indication: Diabetes Mellitus
    Start date: 2009-01-01

Humulin R

Other drugs received by patient: Glyburide



Possible Humulin R side effects in 45 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 45 year old male

Reactions: Impaired Healing, Hypoglycaemia, Ulcer, Blood Glucose Increased

Drug(s) suspected as cause:
Humulin R



Possible Humulin R side effects in 64 year old female

Reported by a consumer/non-health professional from Colombia on 2012-08-22

Patient: 64 year old female

Reactions: Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Humulin N
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-01

Humulin R
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-01



Possible Humulin R side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Bedridden, Emphysema, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin

Atenolol
    Administration route: Oral

Ativan
    Administration route: Oral

Depakote
    Administration route: Oral

Dilantin
    Administration route: Oral

Furosemide
    Administration route: Oral

Generlac

Humulin R

Isosorbide Mononitrate

Lantus
    Dosage: 80 iu, qam

Lantus
    Dosage: 90 df, qpm

Lomotil
    Administration route: Oral

Methocarbamol
    Administration route: Oral

Nitrostat

Norvasc
    Administration route: Oral

Potassium Chloride

Remeron
    Administration route: Oral

Tylenol W / Codeine NO. 3

Zantac

Zocor
    Administration route: Oral



Possible Humulin R side effects in 17 year old female

Reported by a consumer/non-health professional from South Africa on 2012-08-20

Patient: 17 year old female

Reactions: White Blood Cells Urine, Diabetic Ketoacidosis, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin N
    Dosage: 14 u, each evening
    Indication: Diabetes Mellitus
    Start date: 2012-06-14

Humulin R
    Dosage: 12 u, tid
    Indication: Diabetes Mellitus
    Start date: 2012-06-14

Other drugs received by patient: Antihypertensives



Possible Humulin R side effects in 74 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 74 year old male

Reactions: Drug Effect Decreased, General Physical Health Deterioration, Weight Abnormal, Blood Glucose Abnormal

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Humalog
    Dosage: unk unk, tid
    Indication: Diabetes Mellitus

Humalog
    Dosage: unk, tid

Humulin R
    Indication: Diabetes Mellitus



Possible Humulin R side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Cardio-Respiratory Arrest, Pneumonia, Hypoglycaemic Unconsciousness, Blood Glucose Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: 12 u, single
    Start date: 2012-06-05
    End date: 2012-06-05

Humulin R
    Dosage: 20 u, single
    Start date: 2012-06-05

Humulin R
    Dosage: 5 u, single
    Indication: Blood Glucose Increased
    Start date: 2012-06-05

Other drugs received by patient: Ipratropium Bromide; Januvia; Glipizide; Prednisone



Possible Humulin R side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Abasia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Humulin R
    Dosage: unk unk, unknown
    Indication: Type 1 Diabetes Mellitus

Humulin R
    Dosage: unk unk, unknown



Possible Humulin R side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Blood Glucose Decreased, Convulsion

Drug(s) suspected as cause:
Humulin N
    Dosage: unk unk, prn
    Indication: Diabetes Mellitus
    Start date: 1985-01-01

Humulin R
    Dosage: unk unk, prn
    Indication: Diabetes Mellitus
    Start date: 1985-01-01

Other drugs received by patient: Lantus



Possible Humulin R side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Fungal Infection, Drug Hypersensitivity, Hyperglycaemia, Coronary Artery Disease, Hypertension, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: unk unk, unknown
    Indication: Diabetes Mellitus
    End date: 2002-01-01

Humulin N
    Dosage: 25 u, prn
    Indication: Diabetes Mellitus
    Start date: 1987-01-01
    End date: 2012-07-10

Humulin R
    Dosage: unk, unknown
    Indication: Diabetes Mellitus
    Start date: 1987-01-01
    End date: 2012-07-10

Iletin
    Dosage: unk, unknown
    Indication: Diabetes Mellitus

Other drugs received by patient: Lantus



Possible Humulin R side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 49 year old female

Reactions: Drug Dose Omission, Drug Ineffective, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin N
    Dosage: unk unk, bid
    Indication: Type 1 Diabetes Mellitus

Humulin R
    Dosage: unk unk, unknown
    Indication: Type 1 Diabetes Mellitus



Possible Humulin R side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Hypersensitivity, Hypoglycaemia, Musculoskeletal Pain, Urticaria, Autoimmune Thyroiditis, Arthralgia, Adverse Event, Intervertebral Disc Degeneration, Immune System Disorder, Infection

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Humulin N
    Dosage: unk, unknown
    Indication: Type 1 Diabetes Mellitus
    Start date: 1993-10-01

Humulin N
    Dosage: 70 u, unknown

Humulin R
    Dosage: unk, prn
    Indication: Type 1 Diabetes Mellitus
    Start date: 1993-10-01



Possible Humulin R side effects in female

Reported by a consumer/non-health professional from China on 2012-08-13

Patient: female

Reactions: Ketoacidosis, Blood Glucose Increased

Drug(s) suspected as cause:
Humulin R
    Dosage: dose increased

Humulin R
    Indication: Diabetes Mellitus

Lantus Solostar
    Indication: Diabetes Mellitus
    Start date: 2011-12-01

Lantus Solostar
    Dosage: increased dose
    End date: 2011-12-09

Solostar
    Indication: Device Therapy
    Start date: 2011-12-01
    End date: 2011-12-09



Possible Humulin R side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-10

Patient: female, weighing 63.0 kg (138.6 pounds)

Reactions: Dyspnoea, Injection Site Pain, Arrhythmia, Blood Glucose Abnormal, Fatigue, Malaise, Blood Pressure Decreased, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus

Humulin N
    Dosage: 20 iu, each evening
    Start date: 2012-01-01

Humulin N
    Dosage: 26 iu, each morning
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-01-01

Humulin N
    Dosage: 24 iu, other
    Start date: 2012-01-01

Humulin R
    Dosage: unk, unknown
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Amlodipine Besylate; Rosuvastatin; Amlodipine Besylate; Hydrochlorothiazide



Possible Humulin R side effects in 19 year old female

Reported by a physician from Turkey on 2012-08-10

Patient: 19 year old female

Reactions: Hospitalisation, Drug Ineffective, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin R
    Dosage: unk, unknown
    Indication: Type 1 Diabetes Mellitus

Humulin R
    Dosage: 180 u, unknown



Possible Humulin R side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: male

Reactions: Hospitalisation, Visual Impairment, Incorrect Dose Administered

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humalog
    Dosage: 14 u, bid
    Indication: Diabetes Mellitus
    Start date: 2011-01-01

Humulin N

Humulin R
    Indication: Diabetes Mellitus

Other drugs received by patient: Lantus



Possible Humulin R side effects in female

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

Patient: female

Reactions: Wrong Drug Administered, Myocardial Infarction

Adverse event resulted in: hospitalization

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

Humulin R
    Dosage: unk, unknown



Possible Humulin R side effects in male

Reported by a consumer/non-health professional from India on 2012-08-07

Patient: male

Reactions: Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humulin R



Possible Humulin R side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male

Reactions: Convulsion

Adverse event resulted in: hospitalization

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

Humulin R
    Dosage: unk, unknown



Possible Humulin R side effects in 95 year old male

Reported by a physician from France on 2012-08-07

Patient: 95 year old male

Reactions: Gastrointestinal Haemorrhage, Urticaria, Anaphylactic Shock, Gastric Ulcer

Adverse event resulted in: death

Drug(s) suspected as cause:
Humulin R

Other drugs received by patient: Nexium

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