This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Soliris (Eculizumab) 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 (1854)
Death (181)
Life Threatening Events (24)
Disability (5)
Reports by Reaction Type
Haemoglobin Decreased (203),
Fatigue (160),
Headache (145),
Pyrexia (113),
Nausea (102),
Platelet Count Decreased (78),
Haemolysis (77),
Condition Aggravated (76),
Nasopharyngitis (73),
Vomiting (72),
Abdominal Pain (69),
Chromaturia (66)
Below are a few examples of reports where side effects / adverse reactions may be related to Soliris (Eculizumab). For a complete list or a specific selection of reports, please use the links above.
Possible Soliris side effects in male
Reported by a individual with unspecified qualification from United States on 2012-08-27
Patient: male
Reactions: Urine Output Decreased, Platelet Count Decreased, Blood Creatinine Increased, Influenza Like Illness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Death, Muscular Weakness, Mental Status Changes, Fall
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 600 mg, qw
Start date: 2012-05-02
End date: 2012-05-23
Soliris
Dosage: 900 mg, single
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2012-05-30
End date: 2012-05-30
Other drugs received by patient: Compazine; Coumadin; Zofran; Neurontin; Prednisone TAB; Prednisone TAB; Revlimid; Revlimid
Possible Soliris side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Atrial Flutter, Troponin Increased, Myocardial Infarction, Haemolysis, Leukopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 600 mg, qw x 4
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2011-08-02
Soliris
Dosage: 900 mg, q2w
Start date: 2011-09-01
Possible Soliris side effects in female
Reported by a physician from Brazil on 2012-08-27
Patient: female
Reactions: Myalgia, Arthralgia, Meningococcal Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Dosage: 900 mg, q2w
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2011-04-19
End date: 2012-04-04
Soliris
Dosage: 900 mg, q2w
Start date: 2011-09-08
End date: 2012-04-13
Other drugs received by patient: Warfarin Sodium
Possible Soliris side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Intra-Abdominal Haemorrhage, Syncope, Splenic Rupture
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Other drugs received by patient: Calcium Carbonate; Coreg; Aranesp; Valcyte; Ascorbic Acid; Iron; Amlodipine; Vitamin D; Cyclosporine; Lasix; Magnesium Oxide; Myfortic; Pentamidine; Folic Acid; Prednisone TAB; Valcyte
Possible Soliris side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female, weighing 73.1 kg (160.8 pounds)
Reactions: Fatigue, Pneumonia, Nausea, Headache
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in male
Reported by a physician from Germany on 2012-08-24
Patient: male
Reactions: Inappropriate Schedule of Drug Administration, Pneumonia, Urinary Tract Infection, Urosepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 900 mg, q2w
Start date: 2012-03-07
End date: 2012-06-20
Soliris
Dosage: 600 mg, q2w
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2012-02-08
End date: 2012-02-29
Other drugs received by patient: Emestar Mono; Bisoprolol Fumarate; Folsan; Marcumar; Furosemide
Possible Soliris side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female, weighing 72.1 kg (158.6 pounds)
Reactions: Back Pain, White Blood Cell Count Decreased, Haemoglobin Decreased, Cellulitis, Chest Pain, Blood Pressure Decreased, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 600 mg, qw x 4
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2012-04-23
Soliris
Dosage: 900 mg, q2w
Start date: 2012-05-31
End date: 2012-06-14
Other drugs received by patient: Isosorbide Mononitrate CR; Synthroid; Prilosec; Amlodipine Besylate; Ranexa; Nitroglycerin; Lopressor; Aspirin; Crestor; Cymbalta
Possible Soliris side effects in 40 year old female
Reported by a physician from United States on 2012-08-23
Patient: 40 year old female
Reactions: Renal Failure, Breast Cancer Metastatic, Hepatic Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male
Reactions: Retinal Detachment
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-23
Patient: female
Reactions: Thrombosis, Auricular Swelling, Joint Swelling, Oedema Peripheral, Ear Pain
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in female
Reported by a physician from United Kingdom on 2012-08-22
Patient: female
Reactions: Cerebral Infarction, Condition Aggravated, Pupil Fixed, Bradycardia, Haemolytic Uraemic Syndrome, Intracranial Pressure Increased, Escherichia Infection
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Other drugs received by patient: Antibiotics
Possible Soliris side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: female
Reactions: Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Dosage: 600 mg, qw
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2008-03-11
End date: 2008-04-01
Soliris
Dosage: 900 mg, q2w
Start date: 2008-04-08
End date: 2009-10-13
Possible Soliris side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-22
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in 41 year old female
Reported by a physician from United States on 2012-08-21
Patient: 41 year old female
Reactions: Posterior Reversible Encephalopathy Syndrome
Drug(s) suspected as cause:
Soliris
Other drugs received by patient: Antibiotics; Chemotherapy
Possible Soliris side effects in female
Reported by a physician from United States on 2012-08-21
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in male
Reported by a physician from United States on 2012-08-21
Patient: male, weighing 70.3 kg (154.7 pounds)
Reactions: Haemoglobin Decreased, Syncope
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 900 mg, q2w
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2011-12-01
Soliris
Dosage: 600 mg, qw
Start date: 2011-11-29
End date: 2011-12-01
Other drugs received by patient: Revlimid; Aricept; Cartia XT; Ferrous Sulfate TAB; Folic Acid; Namenda; Aspirin; Finasteride; Sertraline Hydrochloride; Hydrochlorothiazide; Levaquin; Simvastatin
Possible Soliris side effects in female
Reported by a physician from United States on 2012-08-21
Patient: female, weighing 74.4 kg (163.6 pounds)
Reactions: Acute Hepatic Failure, Toxicity To Various Agents
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bactrim
Dosage: 400 mg / 60, qd
Administration route: Oral
Indication: Antifungal Prophylaxis
Start date: 2012-06-08
End date: 2012-06-10
Soliris
Dosage: 900 mg, qw
Indication: Haemolytic Uraemic Syndrome
Start date: 2012-06-26
End date: 2012-07-18
Soliris
Indication: Transplant Rejection
Other drugs received by patient: Amlodipine; Cyclosporine; Ascorbic Acid; Calcium Carbonate; Aranesp; Myfortic; Folic Acid; Lasix; Iron; Magnesium Oxide; Coreg; Vitamin D; Valcyte; Valcyte; Iron; Prednisone; Pentamidine
Possible Soliris side effects in male
Reported by a physician from United States on 2012-08-21
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female
Reactions: Abdominal Pain, Haptoglobin Abnormal, Menorrhagia, Blood Creatinine Abnormal, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: unk
Indication: Haemolytic Uraemic Syndrome
Start date: 2012-03-04
Soliris
Dosage: 1200 mg, every 10 days
Start date: 2012-05-05
Possible Soliris side effects in male
Reported by a physician from Turkey on 2012-08-21
Patient: male
Reactions: Pulmonary Oedema, Cardiomyopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in
Reported by a individual with unspecified qualification from United States on 2012-08-21
Patient:
Reactions: Platelet Count Decreased, Abdominal Distension, Pyrexia, Depression, Headache
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female, weighing 73.0 kg (160.6 pounds)
Reactions: Cervical Incompetence, Sinusitis, Retained Placenta or Membranes, Abortion Spontaneous
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisone TAB
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Soliris
Start date: 2012-05-24
Soliris
Indication: Haemolytic Uraemic Syndrome
Start date: 2012-04-25
End date: 2012-05-01
Other drugs received by patient: Progesterone
Possible Soliris side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20
Patient: female, weighing 69.2 kg (152.2 pounds)
Reactions: Normal Pressure Hydrocephalus, Pneumonia Primary Atypical, Contusion, Escherichia Urinary Tract Infection, Restless Legs Syndrome, Fall, Balance Disorder, Dementia Alzheimer's Type, Depression, Thrombocytopenia, Gout, International Normalised Ratio Increased, Atrial Fibrillation, Lumbar Vertebral Fracture, Renal Failure Chronic, Hypothyroidism, Asthenia, Hypertension, Mitral Valve Stenosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Dosage: 5 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Soliris
Dosage: 600 mg, qw
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2012-04-11
End date: 2012-05-09
Soliris
Dosage: 900 mg, q2w
Start date: 2012-05-09
Other drugs received by patient: Allopurinol; Calcium with Vitamin D; Dicyclomine; Aricept; Norco; Levothyroxine Sodium; Vitamin B Complex CAP; Tramadol HCL; Reclast; Carvedilol; Sanctura; Ambien; Coreg; Citalopram Hydrobromide; Folic Acid; Lasix; Mega-RED; Colchicine; Dicyclomine; Ferrous Sulfate TAB; Imodium; Donepezil HCL; Acetaminophen; Ascorbic Acid; Requip; Requip; Diltiazem; Multi-Vitamin
Possible Soliris side effects in female
Reported by a physician from Germany on 2012-08-20
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Soliris
Possible Soliris side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Haemoglobin Decreased, Back Pain, Chest Pain, Platelet Count Decreased, Blood Pressure Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 900 mg, q2w
Start date: 2012-05-31
Soliris
Dosage: 600 mg, qw x 4
Indication: Paroxysmal Nocturnal Haemoglobinuria
Start date: 2012-04-23
Other drugs received by patient: Lopressor; Amlodipine Besylate; Isosorbide Mononitrate CR; Ranexa; Prilosec; Synthroid; Nitroglycerin; Crestor; Cymbalta; Aspirin
Possible Soliris side effects in male
Reported by a physician from Australia on 2012-08-20
Patient: male
Reactions: Malignant Hypertension, Retinopathy Hypertensive, Posterior Reversible Encephalopathy Syndrome, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Other drugs received by patient: Lercanidipine
Possible Soliris side effects in 28 year old male
Reported by a physician from United States on 2012-08-16
Patient: 28 year old male
Reactions: Anaemia, Condition Aggravated, Hemiparesis, Thrombotic Microangiopathy, Staphylococcal Sepsis, Cerebral Infarction, Acute Respiratory Distress Syndrome, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Soliris
Dosage: 600 mg, qw
Indication: Antiphospholipid Syndrome
Start date: 2007-11-01
Soliris
Dosage: 900 mg, qw x3 weeks
Soliris
Dosage: 1200 mg, q2w
Soliris
Dosage: 600 mg every month
Other drugs received by patient: Prednisone TAB; Bivalirudin; Lepirudin; Warfarin Sodium; Prednisone TAB; Hydroxychloroquine Sulfate; Ciprofloxacin
Possible Soliris side effects in 41 year old female
Reported by a physician from United States on 2012-08-16
Patient: 41 year old female
Reactions: Posterior Reversible Encephalopathy Syndrome
Drug(s) suspected as cause:
Soliris
Other drugs received by patient: Antibiotics; Chemotherapy
Possible Soliris side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: female, weighing 58.9 kg (129.6 pounds)
Reactions: Back Pain, Intervertebral Disc Protrusion, Fatigue, Osteoporosis, Nuclear Magnetic Resonance Imaging Abnormal, Depression, Device Breakage
Drug(s) suspected as cause:
Soliris
Other drugs received by patient: Vitamin D3 and Magnesium; Tramadol; Vicodin; Cyclosporine; Folic Acid; Actonel
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