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Pegasys Adverse Events Reported to the FDA Over Time

How are Pegasys adverse event reports trending over time?

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

Most Common Pegasys Adverse Events Reported to the FDA

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

Fatigue
1967 (2.71%)
Anaemia
1690 (2.33%)
White Blood Cell Count Decreased
1650 (2.27%)
Nausea
1330 (1.83%)
Depression
1149 (1.58%)
Platelet Count Decreased
1107 (1.53%)
Weight Decreased
1019 (1.4%)
Pyrexia
963 (1.33%)
Dyspnoea
950 (1.31%)
Asthenia
946 (1.3%)
Insomnia
946 (1.3%)
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Headache
910 (1.25%)
Diarrhoea
759 (1.05%)
Rash
748 (1.03%)
Vomiting
735 (1.01%)
Haemoglobin Decreased
726 (1%)
Dizziness
724 (1%)
Red Blood Cell Count Decreased
641 (.88%)
Pain
603 (.83%)
Arthralgia
570 (.79%)
Alopecia
517 (.71%)
Pruritus
483 (.67%)
Cough
454 (.63%)
Dehydration
444 (.61%)
Anxiety
422 (.58%)
Myalgia
417 (.57%)
Decreased Appetite
404 (.56%)
Neutropenia
404 (.56%)
Death
402 (.55%)
Thrombocytopenia
395 (.54%)
Pneumonia
389 (.54%)
Chest Pain
377 (.52%)
Chills
367 (.51%)
Back Pain
365 (.5%)
Influenza Like Illness
351 (.48%)
Irritability
348 (.48%)
Loss Of Consciousness
348 (.48%)
Malaise
348 (.48%)
Abdominal Pain
330 (.45%)
Anorexia
316 (.44%)
Fall
315 (.43%)
Vision Blurred
311 (.43%)
Convulsion
299 (.41%)
Suicidal Ideation
295 (.41%)
Confusional State
284 (.39%)
Neutrophil Count Decreased
272 (.38%)
Epistaxis
268 (.37%)
Pancytopenia
267 (.37%)
Drug Ineffective
261 (.36%)
Dry Skin
261 (.36%)
Dysgeusia
250 (.34%)
Feeling Abnormal
249 (.34%)
Leukopenia
249 (.34%)
Oedema Peripheral
247 (.34%)
Tremor
247 (.34%)
Amnesia
242 (.33%)
Syncope
242 (.33%)
Weight Increased
235 (.32%)
Memory Impairment
231 (.32%)
Contusion
230 (.32%)
Hepatitis C
229 (.32%)
Abdominal Pain Upper
227 (.31%)
Hyperhidrosis
224 (.31%)
Muscle Spasms
213 (.29%)
Hypoaesthesia
211 (.29%)
Ascites
209 (.29%)
Renal Failure
206 (.28%)
Pain In Extremity
202 (.28%)
Alanine Aminotransferase Increased
194 (.27%)
Stomatitis
187 (.26%)
Hepatic Cirrhosis
185 (.26%)
Dry Mouth
181 (.25%)
Hypertension
180 (.25%)
Paraesthesia
178 (.25%)
Condition Aggravated
177 (.24%)
Hypothyroidism
176 (.24%)
Blood Glucose Increased
172 (.24%)
Abdominal Distension
171 (.24%)
Anger
168 (.23%)
Tinnitus
168 (.23%)
Aspartate Aminotransferase Increase...
161 (.22%)
Urinary Tract Infection
154 (.21%)
Blood Pressure Increased
150 (.21%)
Viral Load Increased
148 (.2%)
Rash Pruritic
146 (.2%)
Constipation
145 (.2%)
Sepsis
145 (.2%)
Nervousness
140 (.19%)
Thrombosis
140 (.19%)
Heart Rate Increased
138 (.19%)
Crying
137 (.19%)
Haemolytic Anaemia
137 (.19%)
Haemorrhage
136 (.19%)
Sinusitis
136 (.19%)
Dyspnoea Exertional
134 (.18%)
Disturbance In Attention
131 (.18%)
Mood Swings
131 (.18%)
Hypotension
129 (.18%)
Ill-defined Disorder
124 (.17%)
Grand Mal Convulsion
120 (.17%)
Haematocrit Decreased
119 (.16%)

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

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

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

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

Hepatitis C
10028
Drug Use For Unknown Indication
1041
Product Used For Unknown Indication
637
Hepatitis C Virus
364
Hepatitis B
206
Hepatitis
75
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Hepatitis C Virus Test
45
Chronic Hepatitis
43
Hepatic Cirrhosis
30
Hiv Infection
21
Hepatitis Viral
12
Chronic Myeloid Leukaemia
11
Hepatitis Chronic Active
9
Cryoglobulinaemia
9
Hepatitis C Positive
8
Hepatitis C Virus Test Positive
7
Myeloproliferative Disorder
7
Liver Disorder
7
Hepatitis D
6
Ill-defined Disorder
6
Hepatitis B Virus Test
6
Myelofibrosis
6
Hepatitis B Virus
5
Polycythaemia Vera
5
Prophylaxis
4
Hepatitis Infectious
4
Coma
4
Anti-infective Therapy
3
Coma Hepatic
3
Malignant Melanoma
3
Drug Exposure During Pregnancy
2
Hepatic Neoplasm Malignant
2
Antiviral Treatment
2
Disease Recurrence
2
Hepatitis C Rna Positive
2
Unevaluable Event
2
Vasculitis
2
Renal Cancer Metastatic
2
Hepatitis C Antibody Positive
2
Systemic Mastocytosis
2
Hepatitis Cholestatic
2
Antiviral Prophylaxis
2
Pregnancy
1
Fibromatosis
1
Viraemia
1
Platelet Count Decreased
1
Organ Transplant
1
Arthropathy
1
Essential Thrombocythaemia
1
Multiple Myeloma
1
Rectal Cancer
1

Drug Labels

LabelLabelerEffective
PegasysGenentech, Inc.11-OCT-11

Pegasys Case Reports

What Pegasys 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 Pegasys. 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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