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Benlysta (Belimumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Benlysta (Belimumab) 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 (650)
Death (26)
Life Threatening Events (8)
Disability (2)

Reports by Reaction Type

Nausea (128)Headache (88)Fatigue (78)Diarrhoea (63)Arthralgia (48)Pruritus (45)Pain (45)Pain in Extremity (44)Pyrexia (43)Vomiting (42)Dyspnoea (41)Dizziness (35)

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

Possible Benlysta side effects in 50 year old female

Reported by a physician from United States on 2012-08-15

Patient: 50 year old female, weighing 67.6 kg (148.7 pounds)

Reactions: Diverticular Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta
    Dosage: 720 montly iv drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-03-01
    End date: 2012-03-25

Benlysta
    Dosage: 720 montly iv drip
    Indication: Panniculitis
    Start date: 2012-03-01
    End date: 2012-03-25



Possible Benlysta side effects in 29 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-10

Patient: 29 year old female, weighing 73.5 kg (161.7 pounds)

Reactions: Abdominal Pain, Pleuritic Pain, Wheezing, Aphasia, Tricuspid Valve Incompetence, Pyrexia, Cardiomegaly, Loss of Consciousness, Pericardial Effusion, Multi-Organ Failure, Chest Pain, Dizziness, Cardiac Failure Congestive, Dyspnoea, Cardiogenic Shock, Respiratory Distress, Mitral Valve Incompetence, Butterfly Rash

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Benlysta
    Dosage: 10 mg/kg, 1 in 4 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-02-24

Benlysta
    Dosage: 10 mg/kg, 1 in 4 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-01-27

Benlysta
    Dosage: 10 mg/kg, 1 in 4 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-02-10

Benlysta
    Dosage: 10 mg/kg, 1 in 4 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-04-20
    End date: 2012-04-20

Benlysta

Other drugs received by patient: Albuterol; Glucosamine (Glucosamine Sulfate); Lyrica; Calcium Carbonate; Oxycodone HCL; Cellcept; Tramadol HCL; Prednisone; Patanol; Acetaminophen; Savella; Multivitan (Vigran) (Ergocalciferol, Ascorbic Acid, Pyridoxine Hydroch; Methotrexate; Imitrex; Flovent; Docusate Sodium; Cyclophosphamide



Possible Benlysta side effects in 40 year old female

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

Patient: 40 year old female, weighing 145.2 kg (319.3 pounds)

Reactions: Weight Decreased, Stomatitis, Diarrhoea, Chills, Dehydration, Pyrexia, Hyperhidrosis, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta
    Dosage: 1 in 1 28 d, intrvenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-05-17

Benlysta
    Dosage: 1 in 1 28 d, intrvenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-04-19

Benlysta
    Dosage: 1 in 1 28 d, intrvenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-05-03

Other drugs received by patient: Pravastatin; Compazine; MS Contin; Plavix; Aldactone; Zofran; Cellcept; Ascorbic Acid; Plaquenil; Ranitidine (Prednisone); Calcium; Propranolol; Reclast; Baclofen; Aciphex; Gabapentin; Metformin Hydrochloride; Prednisolone (Prednisone); Dulcolax; Depo-Provera; Fentora



Possible Benlysta side effects in 48 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-09

Patient: 48 year old female, weighing 113.4 kg (249.5 pounds)

Reactions: Latent Tuberculosis

Drug(s) suspected as cause:
Benlysta
    Dosage: 1 in 28 d, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2011-08-01

Benlysta
    Dosage: 1 in 28 d, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-07-18

Other drugs received by patient: Topamax; Restasis; Potassium; Fentanyl; Forteo; Amitriptyline Hydrochloride; Prednisone; Flexeril; Cardizem; Voltaren; Lasix; Protonix; Tramadol HCL; Plaquenil; Norco (Vicodin) (Paracetamol, Hydrocodone Bitartrate)



Possible Benlysta side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 58 year old female

Reactions: Malaise, Headache

Drug(s) suspected as cause:
Benlysta



Possible Benlysta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female, weighing 79.8 kg (175.6 pounds)

Reactions: Pancreatic Neoplasm, Hypoglycaemia, Diverticulitis, Pancreatic Cyst, Appendix Disorder, Diarrhoea, Blood Glucose Fluctuation, Muscle Spasms

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Methotrexate Sodium; Folic Acid; Ambien; Combigan (Combigan) (Timolol Maleate, Brimonidine Tartrate); Probiotics (Probiotics; Pamine (Hyoscine Methobromide) (Hyoscine Methobromide); Diovan; Antivert (Ancovert) (Nicotinic Acid, Meclozine Hydrochloride); Amlodipine Besilate (Amlodipine Besilate) (Amlodipine Besilate); Toprol (Metoprolol Succinate) (Metoprolol Succinate); Prednisone; Synthroid (Levothyroxine Sodium) (Levothyroxine Sodium); Zoloft; Deilant (Dexalansoprazole (Dexlansoprazole)



Possible Benlysta side effects in female

Reported by a physician from Germany on 2012-08-01

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Benlysta
    Dosage: 1 in 1 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-03-15

Benlysta
    Dosage: 1 in 1 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-05-09

Benlysta
    Dosage: 1 in 1 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-06-07
    End date: 2012-06-07

Benlysta
    Dosage: 1 in 1 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-04-12

Benlysta
    Dosage: 1 in 1 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-01-26

Benlysta
    Dosage: 1 in 1 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-02-16

Other drugs received by patient: Metoprolol Succinate; Prednisolone; Dapsone; Ranitidine Hydrochloride (Ranitidine Hydrochloride) (Ranitidine Hydroc; Omeprazole; Celecoxib; Clemastine Fumarate (Clemastine Fumarate) (Clemastine Fumarate); Hydroxychloroquine Sulphate (Hydroxychloroquine Sulfate) Hydroxychloro



Possible Benlysta side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 53 year old female, weighing 103.9 kg (228.5 pounds)

Reactions: Endometrial Cancer Stage I

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Aspirin; Tramadol Hcl(tramadol Hydrochloride)(tramadol Hydrochloride); Calcium with Vitamin D(calcium + VIT D)(calcium Carbonate, Vitamin D N; Toprol-XL; Paroxetine Hcl(paroxetine Hydrochloride)(paroxetine Hydrochloride); Prednisone; Flexeril(cyclobenzaprine Hydrochloride)(cyclobenzaprine Hydrochloride); Lisinopril; Nexium; Minipress(prazosin Hydrochloride)(prazosin Hydrochloride); Fish OIL (Fish Oil)(fish Oil); Magnesium Oxide(magnesium Oxide)(magnesium Oxide); Allopurinol; Ocuvite(ocuvite / 01053801 / )(ascorbic Acid, Tocopherol, Retinol); Vitamin D3(colecalciferol)(colecalciferol); Neulasta



Possible Benlysta side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-30

Patient: 42 year old female, weighing 77.4 kg (170.3 pounds)

Reactions: Nasopharyngitis, Lymphadenopathy, Pneumonia, Nausea, Alanine Aminotransferase Increased, Pleurisy, Neoplasm Progression, Pyrexia, Abdominal Pain Upper, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Abdominal Distension, Morbid Thoughts, Thyroid Neoplasm, Hallucination

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Oxycontin (Oxycodone Hydrochloride) (Oxycodone Hydrochloride); Nexium; Fluconazole; Modafinil (Modafinil) (Modafinil); Ibuprofen Tablets; Meloxicam



Possible Benlysta side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: female

Reactions: Euphoric Mood, Mood Altered, Therapeutic Response Unexpected, Depression

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Benlysta



Possible Benlysta side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 44 year old female, weighing 69.9 kg (153.7 pounds)

Reactions: Blood Potassium Decreased, Pain in Extremity, Urinary Tract Infection, Skin Mass, Blood Cholesterol Increased, Muscular Weakness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Keppra; Prednisone; Plaquinil (Hydroxychloroquine Phosphate) (Hydroxychloroquine Phosphate; Clobetasol (Clobetasol) (Clobetasol)



Possible Benlysta side effects in 59 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 59 year old female

Reactions: Nightmare, Vomiting, Nausea, non-Cardiac Chest Pain, Gastritis, Suicidal Ideation, Anxiety, Dehydration, Bradycardia, Depressed Mood

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Naproxen; Folate (Folic Acid)(folic Acid); Endocet (Oxyoocet)(paracetamol, Oxycodone Hydrochloride); Aspirin; Topamax (Topiramate)(topiramate); Ambien; Zofran; Colace (Docusate Sodium)(docusate Sodium); Cellcept (Mycophenolate Mofetil)(mycophenolate Mofetil); Lasix; Phenergan (Promethazine)(promethazine); Prempro (Provella-14)(medroxyprogesterone Acetate, Estrogens Conjugate; Cymbalta (Duloxetine Hydrochloride) (Duloxetine Hydrochloride); Neurontin; Potassium (Potassium)(potassium); Prednisone; Vitamin D (Ergocalciferol)(ergocalciferol)



Possible Benlysta side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-24

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Drug Dose Omission, Chest Discomfort, Dyspnoea, Drug Ineffective, Depression, Crying, White Blood Cell Count Increased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Cortisone (Cortisone) (Cortisone)



Possible Benlysta side effects in 44 year old female

Reported by a physician from Germany on 2012-07-23

Patient: 44 year old female

Reactions: Thrombophlebitis, Condition Aggravated, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta
    Dosage: 640 mg, 1 in, intravenous drip 640 mg, 1 in, intravenous drip 640 mg, 1 in, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-03-13

Benlysta
    Dosage: 640 mg, 1 in, intravenous drip 640 mg, 1 in, intravenous drip 640 mg, 1 in, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-03-27

Benlysta
    Dosage: 640 mg, 1 in, intravenous drip 640 mg, 1 in, intravenous drip 640 mg, 1 in, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-04-12
    End date: 2012-04-12

Other drugs received by patient: Paracetamol (Paracetamol) (Paracetamol); Quensyl (Hydroxychloroquine Sulfate) (Hydroxychloroquine Sulfate); Fenistil (Dimetindene Maleate) (Dimetindene Maleate); Prednisolon (Prednisolone) (Prednisolone)



Possible Benlysta side effects in 32 year old female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 32 year old female

Reactions: Dystonia, Contrast Media Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Barium (Barium)

Benlysta
    Dosage: intravenous drip

Other drugs received by patient: Prednisone; Methotrexate; Pentasa (Mesalazine) (Mesalazine)



Possible Benlysta side effects in 64 year old female

Reported by a physician from United States on 2012-07-19

Patient: 64 year old female, weighing 69.9 kg (153.7 pounds)

Reactions: Breast Cancer

Drug(s) suspected as cause:
Benlysta



Possible Benlysta side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-13

Patient: 42 year old female, weighing 77.4 kg (170.3 pounds)

Reactions: Lymphadenopathy, Goitre, Haemorrhagic Cyst, Pyrexia, Abdominal Pain Upper, Blood Acid Phosphatase Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Morbid Thoughts, Hallucination

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Nexium; Oxycontin (Oxycodone Hydrochloride) (Oxycodone Hydrochloride); Meloxicam; Fluconazole; Ibuprofen Tablets; Modafinil (Modafinil) (Modafinil)



Possible Benlysta side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 59 year old female

Reactions: Anxiety Disorder, Nightmare, Vomiting, Nausea, Musculoskeletal Chest Pain, non-Cardiac Chest Pain, Gastritis, Suicidal Ideation, Dehydration, Bradycardia, Depressed Mood

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Cellcept; Colace (Docusate Sodium); Cymbalta; Folate (Folic Acid); Naproxen; Vitamin D; Promethazine; Topamax; Prempro (Provella-14) (Medroxyprogesterone Acetate, Estrogens Conjugat; Neurontin; Endocet (Oxycocet) (Paracetamol, Oxycodone Hydrochloride); Aspirin; Pottasium; Lasix; Ambien; Prednisone; Zofran



Possible Benlysta side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 27 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Dystonia, Feeling Jittery, Feeling Hot, Condition Aggravated, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Xanax; Aspirin; Imuran; Ativan; Prozac; Zoloft; Wellbutrin



Possible Benlysta side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12

Patient: 32 year old female

Reactions: Dystonia, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Methotrexate Sodium; Prednisone TAB; Pentasa



Possible Benlysta side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 70 year old male, weighing 68.9 kg (151.7 pounds)

Reactions: Actinic Keratosis, Rhinorrhoea, Memory Impairment

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Methotrexate; Ascorbic Acid; Multivitamin (Vigran) (Ergocalciferol, Ascorbic Acid, Pyridoxine Hydro; Probiotic (Bifidobacterium Lactis); Lipitor; Metoprolol ER (Metoprolol); Vesicare; Curcumin; Folic Acid; Lovenox; Plaquenil; Levothyroxine Sodium; Vitamin D; Iron; Calcium Carbonate; Plavix



Possible Benlysta side effects in 37 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient: 37 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Protein Urine Present, Swelling Face, Pain, Catatonia, Generalised Oedema, Joint Swelling, Oedema Peripheral, Asthenia, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Prilosec (Omeprazole) (Omeprazole); Omega-3 (Omega-3 Triglycerides) (Omega-3 Triglycerides); Plaquenil; Zantac; Prednisone; Vitamin C (Ascorbic Acid) (Ascorbic Acid); Duragesic (Fentanyl) (Fentanyl)



Possible Benlysta side effects in 29 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-06

Patient: 29 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Multi-Organ Failure, Speech Disorder, Protein Urine Present, RED Blood Cells Urine Positive, Mitral Valve Incompetence, General Physical Health Deterioration, Bacterial Test Positive, Cardiogenic Shock, Cardiac Failure Congestive

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Benlysta
    Dosage: 10 mg/kg, 1 in 4 wk, intravenous drip
    Indication: Systemic Lupus Erythematosus
    Start date: 2012-01-27
    End date: 2012-04-20

Benlysta

Other drugs received by patient: Calcium Carbonate; Flovent; Albuterol; Cyclophosphamide; Prednisone; Oxycodone HCL; Savella; Imitrex; Multivitamin (Vigran) (Ergocalciferol, Ascorbic Acid, Pyridoxine Hydro; Patanol; Cellcept; Tramadol Hydrochloride; Acetaminophen; Lyrica; Methotrexate; Glucosamine (Glucosamine Sulfate); Docusate Sodium



Possible Benlysta side effects in 62 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-05

Patient: 62 year old female, weighing 85.3 kg (187.6 pounds)

Reactions: Confusional State, Pneumonia, Contusion, Feeling Abnormal, Fall, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Acidophilus (Lactobacilus Acidophilus) (Lactobacillus Acidophilus); Lumigan EYE Drops (Bimatoprost) (Bimatoprost); Levothyroxine Sodium; Celebrex; Ambien; Hydrochlorothiazide (Benzylhydrochlorothiazide)(benzylhydrochlorothiaz; Theodur (Theophylline) (Theophylline); Elavil (Amitriptyline Hydrochloride) (Amitriptyline Hydrochloride); Imuran; Plaquenil (Hydroxychloroquine Phosphate) (Hydroxychloroquine Phosphate; Diamox (Acetazolamide) (Acetazolamide); Prednisone; Methadone (Methadone) (Methadone); Fosamax; Neurontin; Omeprazole; Calcium with Vitamin D (OS-CAL / 00188401 / (Ergocalciferol, Calcium)



Possible Benlysta side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-05

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Benlysta



Possible Benlysta side effects in female

Reported by a physician from Germany on 2012-07-05

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Diplopia, Dyspnoea, Nausea, Chills, Vision Blurred

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Prednisolon (Prednisolone)(prednisolone); Quensyl (Hydroxychloroquine Sulfate)(hydroxychloroquine Sulfate); Folsan (Folic Acid)(folic Acid); Methotrexate



Possible Benlysta side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 69 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Pneumocystis Jiroveci Pneumonia, Chromaturia, Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Levoxyl (Levothyroxine Sodium) (Levothyroxine Sodium); Azathioprine (Azathioprine) (Azathioprine)



Possible Benlysta side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-27

Patient: female

Reactions: Malaise, Neutropenia, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta



Possible Benlysta side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: 59 year old female

Reactions: Vomiting, Heart Rate Decreased, Nausea, Chest Pain, Depressed Mood, Suicidal Ideation, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benlysta



Possible Benlysta side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-27

Patient: 34 year old female

Reactions: Malaise, Hypersensitivity, Chills, Peripheral Vascular Disorder, Dizziness, Cardiovascular Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Benlysta

Other drugs received by patient: Methotrexate Sodium; Hydroxychloroquine Sulfate; Prednisolone

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