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COPEGUS

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Copegus Adverse Events Reported to the FDA Over Time

How are Copegus adverse event reports trending over time?

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

Most Common Copegus Adverse Events Reported to the FDA

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

Fatigue
896 (2.7%)
Anaemia
820 (2.47%)
White Blood Cell Count Decreased
774 (2.33%)
Nausea
610 (1.84%)
Depression
550 (1.65%)
Pyrexia
509 (1.53%)
Platelet Count Decreased
449 (1.35%)
Insomnia
448 (1.35%)
Weight Decreased
446 (1.34%)
Headache
421 (1.27%)
Dyspnoea
419 (1.26%)
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Asthenia
416 (1.25%)
Rash
381 (1.15%)
Haemoglobin Decreased
361 (1.09%)
Vomiting
346 (1.04%)
Dizziness
340 (1.02%)
Diarrhoea
313 (.94%)
Red Blood Cell Count Decreased
282 (.85%)
Pain
269 (.81%)
Alopecia
252 (.76%)
Arthralgia
244 (.73%)
Pruritus
243 (.73%)
Dehydration
220 (.66%)
Myalgia
219 (.66%)
Thrombocytopenia
217 (.65%)
Cough
216 (.65%)
Irritability
202 (.61%)
Neutropenia
199 (.6%)
Pneumonia
198 (.6%)
Chest Pain
189 (.57%)
Chills
186 (.56%)
Influenza Like Illness
184 (.55%)
Abdominal Pain
183 (.55%)
Back Pain
181 (.54%)
Anxiety
180 (.54%)
Decreased Appetite
162 (.49%)
Pancytopenia
159 (.48%)
Anorexia
158 (.48%)
Death
153 (.46%)
Loss Of Consciousness
150 (.45%)
Vision Blurred
146 (.44%)
Suicidal Ideation
131 (.39%)
Confusional State
127 (.38%)
Tremor
125 (.38%)
Syncope
122 (.37%)
Epistaxis
120 (.36%)
Fall
118 (.36%)
Dry Skin
117 (.35%)
Convulsion
116 (.35%)
Contusion
115 (.35%)
Memory Impairment
112 (.34%)
Oedema Peripheral
112 (.34%)
Drug Ineffective
109 (.33%)
Leukopenia
106 (.32%)
Weight Increased
106 (.32%)
Amnesia
105 (.32%)
Anger
105 (.32%)
Neutrophil Count Decreased
105 (.32%)
Feeling Abnormal
100 (.3%)
Malaise
100 (.3%)
Hyperhidrosis
96 (.29%)
Tinnitus
96 (.29%)
Muscle Spasms
91 (.27%)
Dysgeusia
90 (.27%)
Ascites
89 (.27%)
Urinary Tract Infection
89 (.27%)
Abdominal Pain Upper
88 (.26%)
Alanine Aminotransferase Increased
87 (.26%)
Dry Mouth
86 (.26%)
Renal Failure
86 (.26%)
Dyspnoea Exertional
82 (.25%)
Nervousness
82 (.25%)
Blood Glucose Increased
81 (.24%)
Haemolytic Anaemia
81 (.24%)
Hypothyroidism
81 (.24%)
Stomatitis
80 (.24%)
Pain In Extremity
77 (.23%)
Blood Pressure Increased
76 (.23%)
Hepatitis C
76 (.23%)
Abdominal Distension
75 (.23%)
Hypoaesthesia
74 (.22%)
Aspartate Aminotransferase Increase...
73 (.22%)
Heart Rate Increased
73 (.22%)
Hepatic Cirrhosis
73 (.22%)
Cholelithiasis
70 (.21%)
Sepsis
70 (.21%)
Condition Aggravated
67 (.2%)
Haemoptysis
66 (.2%)
Viral Load Increased
65 (.2%)
Hypertension
64 (.19%)
Sinusitis
63 (.19%)
Haemorrhage
62 (.19%)
Abortion Spontaneous
61 (.18%)
Bronchitis
61 (.18%)
Crying
61 (.18%)
General Physical Health Deteriorati...
61 (.18%)
Infection
60 (.18%)
Migraine
60 (.18%)
Mood Swings
60 (.18%)
Drug Exposure During Pregnancy
59 (.18%)
Grand Mal Convulsion
59 (.18%)

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

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

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

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

Hepatitis C
4258
Drug Use For Unknown Indication
609
Hepatitis C Virus
259
Product Used For Unknown Indication
145
Hepatitis
43
Hepatic Cirrhosis
18
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Chronic Hepatitis
13
Hiv Infection
10
Hepatitis C Positive
8
Cryoglobulinaemia
7
Hepatitis Viral
5
Hepatitis C Virus Test Positive
4
Chronic Myeloid Leukaemia
4
Hepatitis B
4
Hepatitis C Virus Test
4
Ill-defined Disorder
3
Neutropenia
3
Prophylaxis
2
Thrombocytopenia
2
Viraemia
2
Lymphoma
2
Hepatitis C Antibody Positive
2
Encephalitis
2
Death
1
Renal Failure
1
Unevaluable Event
1
Drug Exposure During Pregnancy
1
Renal Cell Carcinoma
1
Dehydration
1
Antiviral Prophylaxis
1
Pneumonia
1
Sepsis
1
Drug Therapy
1
Dyspepsia
1
Disease Recurrence
1
Viral Infection
1
Pregnancy
1

Drug Labels

LabelLabelerEffective
CopegusGenentech, Inc.19-FEB-13

Copegus Case Reports

What Copegus 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 Copegus. 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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