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Viracept Adverse Events Reported to the FDA Over Time

How are Viracept adverse event reports trending over time?

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

Most Common Viracept Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
415 (8.98%)
Maternal Drugs Affecting Foetus
83 (1.8%)
Pregnancy
75 (1.62%)
Premature Baby
75 (1.62%)
Cardiac Murmur
70 (1.51%)
Abdominal Distension
68 (1.47%)
Lipodystrophy Acquired
67 (1.45%)
Cryptorchism
64 (1.38%)
Congenital Anomaly
60 (1.3%)
Abdominal Hernia
52 (1.13%)
Eyelid Ptosis
51 (1.1%)
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Caesarean Section
49 (1.06%)
Mitochondrial Toxicity
48 (1.04%)
Diplopia
44 (.95%)
Progressive External Ophthalmoplegi...
43 (.93%)
Abortion Spontaneous
42 (.91%)
Diarrhoea
36 (.78%)
Atrial Septal Defect
33 (.71%)
Aspartate Aminotransferase Increase...
31 (.67%)
Intra-uterine Death
30 (.65%)
Polydactyly
30 (.65%)
Drug Toxicity
29 (.63%)
Lymphadenopathy
29 (.63%)
Stillbirth
29 (.63%)
Alanine Aminotransferase Increased
28 (.61%)
Hypertension
27 (.58%)
Anaemia
26 (.56%)
Nausea
25 (.54%)
Trisomy 21
25 (.54%)
Rash
24 (.52%)
Hyperlipidaemia
23 (.5%)
Pyrexia
23 (.5%)
Immune Reconstitution Syndrome
22 (.48%)
Ascites
21 (.45%)
Cachexia
21 (.45%)
Cholestasis
21 (.45%)
Renal Impairment
21 (.45%)
Blood Lactate Dehydrogenase Increas...
20 (.43%)
Acute Hepatic Failure
19 (.41%)
Asthenia
19 (.41%)
Hepatic Function Abnormal
19 (.41%)
Myopathy
19 (.41%)
Premature Labour
19 (.41%)
Splenomegaly
19 (.41%)
Osteonecrosis
18 (.39%)
Graft Dysfunction
17 (.37%)
Hepatic Encephalopathy
17 (.37%)
Osteoporosis
17 (.37%)
Pleural Effusion
17 (.37%)
Portal Hypertension
17 (.37%)
Varices Oesophageal
17 (.37%)
Drug Ineffective
16 (.35%)
Drug Interaction
16 (.35%)
Fatigue
16 (.35%)
Pharyngitis
16 (.35%)
Transplant Rejection
16 (.35%)
Vomiting
16 (.35%)
Cleft Lip And Palate
15 (.32%)
Hepatic Enzyme Increased
15 (.32%)
Hepatotoxicity
15 (.32%)
Liver Disorder
15 (.32%)
Neonatal Disorder
15 (.32%)
Ventricular Septal Defect
15 (.32%)
Abdominal Pain
14 (.3%)
Abortion Induced
14 (.3%)
Disease Recurrence
14 (.3%)
Jaundice
14 (.3%)
Liver Function Test Abnormal
14 (.3%)
Patent Ductus Arteriosus
14 (.3%)
Premature Rupture Of Membranes
14 (.3%)
Weight Decreased
14 (.3%)
Liver Transplant
13 (.28%)
Portal Hypertensive Gastropathy
13 (.28%)
Abdominal Pain Upper
12 (.26%)
Haemoglobin Decreased
12 (.26%)
Hiv Infection
12 (.26%)
Lactic Acidosis
12 (.26%)
Neonatal Respiratory Distress Syndr...
12 (.26%)
Respiratory Distress
12 (.26%)
Sickle Cell Anaemia
12 (.26%)
Congenital Hydronephrosis
11 (.24%)
Convulsion
11 (.24%)
Drug Resistance
11 (.24%)
Hydronephrosis
11 (.24%)
Hypospadias
11 (.24%)
Pulmonary Artery Stenosis Congenita...
11 (.24%)
Renal Disorder
11 (.24%)
Foetal Disorder
10 (.22%)
Gastrooesophageal Reflux Disease
10 (.22%)
Hepatitis
10 (.22%)
Mitral Valve Incompetence
10 (.22%)
Neutropenia
10 (.22%)
Placental Disorder
10 (.22%)
Prothrombin Level Decreased
10 (.22%)
Pulmonary Hypertension
10 (.22%)
Trisomy 18
10 (.22%)
Ventricular Hypertrophy
10 (.22%)
Blood Lactic Acid Increased
9 (.19%)
Congenital Abdominal Hernia
9 (.19%)
Congestive Cardiomyopathy
9 (.19%)
Foetal Distress Syndrome
9 (.19%)

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

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

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

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

Hiv Infection
1125
Hiv Test Positive
137
Antiretroviral Therapy
66
Acquired Immunodeficiency Syndrome
59
Drug Exposure During Pregnancy
43
Drug Use For Unknown Indication
21
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Antiviral Prophylaxis
19
Ill-defined Disorder
18
Prophylaxis Against Hiv Infection
16
Antiviral Treatment
14
Prophylaxis
13
Product Used For Unknown Indication
9
Asymptomatic Hiv Infection
7
Systemic Antiviral Treatment
5
Viral Infection
5
Infection Prophylaxis
3
Headache
3
Pathogen Resistance
2
Accidental Exposure
2
Lentivirus Test Positive
2
Vertical Infection Transmission
2
Acute Hiv Infection
2
Accidental Needle Stick
2
Hiv Infection Cdc Group Iv Subgroup...
1
Retroviral Infection
1
Rectal Cancer
1
Mantle Cell Lymphoma
1
Pregnancy
1
Mental Status Changes
1
Maternal Exposure During Pregnancy
1
Maternal Exposure Timing Unspecifie...
1
Retroperitoneal Cancer
1

Drug Labels

LabelLabelerEffective
ViraceptState of Florida DOH Central Pharmacy13-APR-10
ViraceptPD-Rx Pharmaceuticals, Inc.21-APR-11
Viracept H.J. Harkins Company, Inc.18-APR-12
ViraceptAGOURON PHARMACEUTICALS INC31-OCT-12
ViraceptREMEDYREPACK INC. 27-MAR-13
ViraceptAGOURON PHARMACEUTICALS INC08-APR-13

Viracept Case Reports

What Viracept 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 Viracept. 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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