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Soliris Adverse Events Reported to the FDA Over Time

How are Soliris adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Soliris, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Soliris is flagged as the suspect drug causing the adverse event.

Most Common Soliris Adverse Events Reported to the FDA

What are the most common Soliris adverse events reported to the FDA?

Haemoglobin Decreased
1601 (4%)
Fatigue
1251 (3.13%)
Headache
1247 (3.12%)
Pyrexia
848 (2.12%)
Haemolysis
729 (1.82%)
Nausea
636 (1.59%)
Back Pain
542 (1.36%)
Blood Lactate Dehydrogenase Increas...
537 (1.34%)
Abdominal Pain
496 (1.24%)
Platelet Count Decreased
493 (1.23%)
Nasopharyngitis
488 (1.22%)
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Dyspnoea
456 (1.14%)
Anaemia
437 (1.09%)
Asthenia
435 (1.09%)
Vomiting
421 (1.05%)
Condition Aggravated
401 (1%)
Chromaturia
388 (.97%)
Pneumonia
384 (.96%)
Pain
382 (.96%)
Diarrhoea
372 (.93%)
Dizziness
342 (.86%)
Arthralgia
324 (.81%)
Cough
289 (.72%)
Death
283 (.71%)
Pain In Extremity
262 (.66%)
Urinary Tract Infection
258 (.65%)
Sepsis
252 (.63%)
Oedema Peripheral
251 (.63%)
Malaise
250 (.63%)
Drug Ineffective
245 (.61%)
Haemoglobinuria
242 (.61%)
White Blood Cell Count Decreased
242 (.61%)
Haematocrit Decreased
235 (.59%)
Chest Pain
223 (.56%)
Chills
211 (.53%)
Fall
201 (.5%)
Dehydration
184 (.46%)
Abdominal Pain Upper
177 (.44%)
Infection
176 (.44%)
Influenza
176 (.44%)
Sinusitis
167 (.42%)
Viral Infection
165 (.41%)
Blood Bilirubin Increased
163 (.41%)
Pancytopenia
159 (.4%)
Oropharyngeal Pain
153 (.38%)
Hypotension
148 (.37%)
Myalgia
143 (.36%)
Neutropenia
139 (.35%)
Renal Failure Acute
136 (.34%)
Feeling Abnormal
135 (.34%)
Upper Respiratory Tract Infection
135 (.34%)
Rash
133 (.33%)
Cellulitis
130 (.33%)
Jaundice
130 (.33%)
Pruritus
130 (.33%)
Dysphagia
128 (.32%)
Weight Decreased
127 (.32%)
Decreased Appetite
123 (.31%)
Paroxysmal Nocturnal Haemoglobinuri...
123 (.31%)
Rhinorrhoea
121 (.3%)
Myelodysplastic Syndrome
118 (.3%)
Renal Failure
118 (.3%)
Septic Shock
116 (.29%)
Cholelithiasis
115 (.29%)
Transfusion
115 (.29%)
Thrombocytopenia
114 (.29%)
Atrial Fibrillation
113 (.28%)
Muscle Spasms
112 (.28%)
Unevaluable Event
111 (.28%)
Febrile Neutropenia
110 (.28%)
Aplastic Anaemia
108 (.27%)
Insomnia
106 (.27%)
Cardiac Failure Congestive
105 (.26%)
Contusion
103 (.26%)
Chest Discomfort
102 (.26%)
Influenza Like Illness
102 (.26%)
Hypertension
101 (.25%)
Epistaxis
100 (.25%)
Depression
99 (.25%)
Haematuria
98 (.25%)
Thrombosis
97 (.24%)
Palpitations
96 (.24%)
Pregnancy
93 (.23%)
Respiratory Failure
92 (.23%)
Staphylococcal Infection
92 (.23%)
Erythema
91 (.23%)
Blood Count Abnormal
89 (.22%)
Nasal Congestion
86 (.22%)
Blood Product Transfusion Dependent
84 (.21%)
Confusional State
84 (.21%)
Arthritis
83 (.21%)
Blood Creatinine Increased
82 (.21%)
Blood Iron Increased
80 (.2%)
Migraine
80 (.2%)
Hypersensitivity
78 (.2%)
Neck Pain
76 (.19%)
Blood Glucose Increased
75 (.19%)
Bronchitis
73 (.18%)
Multi-organ Failure
73 (.18%)
Cerebrovascular Accident
72 (.18%)
Drug Dose Omission
72 (.18%)

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This graph shows the top adverse events submitted to the FDA for Soliris, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Soliris is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Soliris

What are the most common Soliris adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Soliris, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Soliris is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Soliris According to Those Reporting Adverse Events

Why are people taking Soliris, according to those reporting adverse events to the FDA?

Paroxysmal Nocturnal Haemoglobinuri...
6422
Haemolytic Uraemic Syndrome
418
Prophylaxis Against Transplant Reje...
48
Product Used For Unknown Indication
21
Thrombotic Microangiopathy
15
Malignant Atrophic Papulosis
13
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Transplant Rejection
12
Drug Use For Unknown Indication
10
Cold Type Haemolytic Anaemia
10
Antiphospholipid Syndrome
10
Aplastic Anaemia
9
Off Label Use
9
Anaemia Haemolytic Autoimmune
8
Haemolysis
8
Familial Risk Factor
5
Haemoglobinuria
4
Thrombotic Thrombocytopenic Purpura
3
Renal Transplant
3
Glomerulonephritis Membranoprolifer...
3
Thrombosis
3
Blood Product Transfusion Dependent
3
Dowling-degos Disease
2
Multifocal Motor Neuropathy
2
Hellp Syndrome
2
Thrombosis Prophylaxis
2
Pre-eclampsia
2
Accidental Exposure
2
Prophylaxis
2
Maternal Exposure During Pregnancy
2
Lung Transplant
1
Coagulopathy
1
Glomerulonephritis
1
Drug Exposure During Pregnancy
1
Neuromyelitis Optica
1
Haemoglobinaemia
1
Platelet Count Decreased
1
Peripheral Motor Neuropathy
1
Haemolytic Anaemia
1
Lymphoma
1
Heart Transplant
1
Idiopathic Thrombocytopenic Purpura
1

Drug Labels

LabelLabelerEffective
SolirisAlexion Pharmaceuticals, Inc.15-DEC-12

Soliris Case Reports

What Soliris safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Soliris. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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