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BOCEPREVIR

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Boceprevir Adverse Events Reported to the FDA Over Time

How are Boceprevir adverse event reports trending over time?

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

Most Common Boceprevir Adverse Events Reported to the FDA

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

Anaemia
112 (5%)
Fatigue
46 (2.05%)
Neutropenia
45 (2.01%)
Pyrexia
41 (1.83%)
Asthenia
37 (1.65%)
White Blood Cell Count Decreased
35 (1.56%)
Nausea
31 (1.38%)
Vomiting
30 (1.34%)
Diarrhoea
29 (1.29%)
Weight Decreased
29 (1.29%)
Dyspnoea
28 (1.25%)
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Haemoglobin Decreased
27 (1.2%)
Platelet Count Decreased
22 (.98%)
Pain
21 (.94%)
General Physical Health Deteriorati...
19 (.85%)
Pancytopenia
19 (.85%)
Syncope
19 (.85%)
Decreased Appetite
18 (.8%)
Depression
18 (.8%)
Dysgeusia
17 (.76%)
Sepsis
17 (.76%)
Thrombocytopenia
17 (.76%)
Back Pain
16 (.71%)
Urinary Tract Infection
16 (.71%)
Confusional State
15 (.67%)
Leukopenia
15 (.67%)
Fall
14 (.62%)
Hyponatraemia
14 (.62%)
Insomnia
14 (.62%)
Rash
14 (.62%)
Oropharyngeal Pain
13 (.58%)
Renal Failure Acute
13 (.58%)
Ascites
12 (.54%)
Hypotension
12 (.54%)
Red Blood Cell Count Decreased
12 (.54%)
Renal Failure
12 (.54%)
Septic Shock
12 (.54%)
Urticaria
12 (.54%)
Dehydration
11 (.49%)
Dysphagia
11 (.49%)
Malaise
11 (.49%)
Mood Swings
11 (.49%)
Multi-organ Failure
11 (.49%)
Abdominal Pain
10 (.45%)
Atrial Fibrillation
10 (.45%)
Headache
10 (.45%)
Aggression
9 (.4%)
Chills
9 (.4%)
Condition Aggravated
9 (.4%)
Dizziness
9 (.4%)
Dyspnoea Exertional
9 (.4%)
Hepatic Cirrhosis
9 (.4%)
Hypokalaemia
9 (.4%)
Irritability
9 (.4%)
Lung Disorder
9 (.4%)
Oedema Peripheral
9 (.4%)
Pneumonia
9 (.4%)
Erysipelas
8 (.36%)
Hepatic Neoplasm Malignant
8 (.36%)
Abdominal Distension
7 (.31%)
Anaemia Macrocytic
7 (.31%)
Bacteraemia
7 (.31%)
Blood Creatinine Increased
7 (.31%)
Cardiac Murmur
7 (.31%)
Cellulitis
7 (.31%)
Chest Pain
7 (.31%)
Cough
7 (.31%)
Death
7 (.31%)
Dysuria
7 (.31%)
Feeling Abnormal
7 (.31%)
Full Blood Count Decreased
7 (.31%)
Haemolytic Anaemia
7 (.31%)
Pneumonia Staphylococcal
7 (.31%)
Pruritus
7 (.31%)
Pulmonary Embolism
7 (.31%)
Stomatitis
7 (.31%)
Agitation
6 (.27%)
Angioedema
6 (.27%)
Drug Ineffective
6 (.27%)
Dysphonia
6 (.27%)
Escherichia Infection
6 (.27%)
Mucosal Inflammation
6 (.27%)
No Therapeutic Response
6 (.27%)
Oedema
6 (.27%)
Respiratory Failure
6 (.27%)
Somnolence
6 (.27%)
Vertigo
6 (.27%)
Anger
5 (.22%)
Anxiety
5 (.22%)
Arthralgia
5 (.22%)
Blood Potassium Decreased
5 (.22%)
Bronchitis
5 (.22%)
Constipation
5 (.22%)
Depressed Mood
5 (.22%)
Emotional Disorder
5 (.22%)
Escherichia Sepsis
5 (.22%)
Febrile Neutropenia
5 (.22%)
Fluid Retention
5 (.22%)
Gait Disturbance
5 (.22%)
Hepatitis C
5 (.22%)
Hypersomnia
5 (.22%)

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This graph shows the top adverse events submitted to the FDA for Boceprevir, 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 Boceprevir 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 Boceprevir

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

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This graph shows the top categories of adverse events submitted to the FDA for Boceprevir, 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 Boceprevir 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 Boceprevir According to Those Reporting Adverse Events

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

Hepatitis C
427
Product Used For Unknown Indication
30
Chronic Hepatitis
8
Hepatic Cirrhosis
8
Liver Disorder
2
Fibrosis
2
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Hepatitis Chronic Active
1
Arthritis
1

Drug Labels

LabelLabelerEffective
VictrelisMerck Sharp & Dohme Corp.27-FEB-13

Boceprevir Case Reports

What Boceprevir 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 Boceprevir. 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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