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Soliris (Eculizumab) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 2012-08-22

Patient: female

Reactions: Death

Adverse event resulted in: death

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 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 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 2012-08-20

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 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 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



Possible Soliris side effects in male

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

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Cholelithiasis, Haemoglobin Decreased, Abdominal Pain, Jaundice, Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soliris
    Dosage: 600 mg, qw
    Start date: 2011-08-05
    End date: 2011-08-26

Soliris
    Dosage: 900 mg, q2w
    Indication: Paroxysmal Nocturnal Haemoglobinuria
    Start date: 2011-09-02

Other drugs received by patient: Folic Acid; Iron



Possible Soliris side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Myocardial Infarction, Leukopenia, Haemolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Soliris

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