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INCIVO

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Incivo Adverse Events Reported to the FDA Over Time

How are Incivo adverse event reports trending over time?

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

Most Common Incivo Adverse Events Reported to the FDA

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

Rash
123 (6.04%)
Anaemia
103 (5.06%)
Nausea
53 (2.6%)
Pruritus
49 (2.41%)
Pancytopenia
47 (2.31%)
Drug Rash With Eosinophilia And Sys...
40 (1.96%)
Pyrexia
40 (1.96%)
Asthenia
39 (1.91%)
General Physical Health Deteriorati...
36 (1.77%)
Thrombocytopenia
36 (1.77%)
Off Label Use
35 (1.72%)
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Fatigue
29 (1.42%)
Vomiting
27 (1.33%)
Rash Generalised
25 (1.23%)
Toxic Skin Eruption
25 (1.23%)
Dyspnoea
24 (1.18%)
Diarrhoea
21 (1.03%)
Headache
21 (1.03%)
Blood Creatinine Increased
20 (.98%)
Drug Interaction
20 (.98%)
Neutropenia
17 (.83%)
Depression
16 (.79%)
Inappropriate Schedule Of Drug Admi...
16 (.79%)
Leukopenia
16 (.79%)
Proctalgia
16 (.79%)
Rash Maculo-papular
16 (.79%)
Confusional State
13 (.64%)
Haemoglobin Decreased
13 (.64%)
Pancreatitis
13 (.64%)
Bronchopneumonia
12 (.59%)
Death
12 (.59%)
Fall
12 (.59%)
Rectal Haemorrhage
11 (.54%)
Sepsis
11 (.54%)
Syncope
11 (.54%)
Urinary Tract Infection
11 (.54%)
Decreased Appetite
10 (.49%)
Dizziness
10 (.49%)
Drug Eruption
10 (.49%)
Haemorrhoids
10 (.49%)
Insomnia
10 (.49%)
Renal Failure Acute
10 (.49%)
Cardiac Arrest
9 (.44%)
Dermatitis Exfoliative
9 (.44%)
Eczema
9 (.44%)
Eosinophilia
9 (.44%)
Hyperuricaemia
9 (.44%)
Oedema
9 (.44%)
Face Oedema
8 (.39%)
Herpes Zoster
8 (.39%)
Malaise
8 (.39%)
Pain
8 (.39%)
Pancreatitis Acute
8 (.39%)
Rhabdomyolysis
8 (.39%)
Tremor
8 (.39%)
Vertigo
8 (.39%)
Alanine Aminotransferase Increased
7 (.34%)
Anal Pruritus
7 (.34%)
Dehydration
7 (.34%)
Disorientation
7 (.34%)
Dry Skin
7 (.34%)
Encephalopathy
7 (.34%)
Erythema
7 (.34%)
Haemolytic Anaemia
7 (.34%)
Hypokalaemia
7 (.34%)
Pollakiuria
7 (.34%)
Renal Failure
7 (.34%)
Ascites
6 (.29%)
Blister
6 (.29%)
Drug Intolerance
6 (.29%)
Drug Prescribing Error
6 (.29%)
Dysgeusia
6 (.29%)
Hepatic Cirrhosis
6 (.29%)
Hyperglycaemia
6 (.29%)
Memory Impairment
6 (.29%)
Rash Erythematous
6 (.29%)
Viith Nerve Paralysis
6 (.29%)
Visual Impairment
6 (.29%)
Acute Generalised Exanthematous Pus...
5 (.25%)
Alopecia
5 (.25%)
Anal Fissure
5 (.25%)
Atrial Fibrillation
5 (.25%)
Balance Disorder
5 (.25%)
Cerebellar Syndrome
5 (.25%)
Drug Level Increased
5 (.25%)
Dysphagia
5 (.25%)
Lower Respiratory Tract Infection
5 (.25%)
Lymphadenopathy Mediastinal
5 (.25%)
Medication Error
5 (.25%)
Oedema Peripheral
5 (.25%)
Pain In Extremity
5 (.25%)
Pneumonia
5 (.25%)
Rash Pustular
5 (.25%)
Renal Impairment
5 (.25%)
Skin Lesion
5 (.25%)
Vasculitis
5 (.25%)
Weight Decreased
5 (.25%)
Acute Respiratory Distress Syndrome
4 (.2%)
Anuria
4 (.2%)
Aphthous Stomatitis
4 (.2%)
Aversion
4 (.2%)

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

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

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

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

Hepatitis C
526
Product Used For Unknown Indication
141
Hepatic Cirrhosis
2
Chronic Hepatitis
1
Hepatitis C Rna Positive
1
Hepatitis Viral
1
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Incivo Case Reports

What Incivo 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 Incivo. 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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