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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