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NORVIR

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Norvir Adverse Events Reported to the FDA Over Time

How are Norvir adverse event reports trending over time?

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

Most Common Norvir Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
727 (3.49%)
Pyrexia
284 (1.36%)
Abortion Spontaneous
269 (1.29%)
Premature Baby
232 (1.11%)
Renal Failure Acute
216 (1.04%)
Diarrhoea
191 (.92%)
Nausea
185 (.89%)
Pregnancy
176 (.84%)
Vomiting
169 (.81%)
Drug Interaction
144 (.69%)
Blood Bilirubin Increased
139 (.67%)
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Cytolytic Hepatitis
135 (.65%)
Anaemia
130 (.62%)
Immune Reconstitution Syndrome
126 (.6%)
Rash
126 (.6%)
Jaundice
117 (.56%)
Abdominal Pain
110 (.53%)
Aspartate Aminotransferase Increase...
110 (.53%)
Dyspnoea
109 (.52%)
Asthenia
106 (.51%)
Alanine Aminotransferase Increased
104 (.5%)
Lipodystrophy Acquired
104 (.5%)
Renal Failure
100 (.48%)
Renal Impairment
94 (.45%)
Hypertension
93 (.45%)
Abortion Induced
91 (.44%)
Myocardial Infarction
91 (.44%)
Nephrolithiasis
91 (.44%)
Weight Decreased
89 (.43%)
Hyperbilirubinaemia
88 (.42%)
Gamma-glutamyltransferase Increased
81 (.39%)
Headache
81 (.39%)
Renal Colic
81 (.39%)
Congenital Anomaly
80 (.38%)
Stillbirth
80 (.38%)
Osteonecrosis
77 (.37%)
Fatigue
76 (.36%)
Hepatic Cirrhosis
76 (.36%)
Pruritus
74 (.35%)
Thrombocytopenia
74 (.35%)
Exomphalos
72 (.35%)
Anal Atresia
70 (.34%)
Dehydration
70 (.34%)
Maternal Drugs Affecting Foetus
69 (.33%)
Death
68 (.33%)
Drug Rash With Eosinophilia And Sys...
68 (.33%)
Malaise
68 (.33%)
Blood Alkaline Phosphatase Increase...
66 (.32%)
Caesarean Section
66 (.32%)
Cholestasis
66 (.32%)
Lactic Acidosis
64 (.31%)
Congenital Genital Malformation
63 (.3%)
Diabetes Mellitus
63 (.3%)
Pancreatitis
63 (.3%)
Hepatic Failure
62 (.3%)
Myalgia
62 (.3%)
Pneumonia
62 (.3%)
Umbilical Cord Abnormality
62 (.3%)
Convulsion
61 (.29%)
Normal Newborn
61 (.29%)
Hypokalaemia
60 (.29%)
General Physical Health Deteriorati...
59 (.28%)
Hepatitis
59 (.28%)
Liver Function Test Abnormal
59 (.28%)
Hepatic Enzyme Increased
58 (.28%)
Hepatic Function Abnormal
58 (.28%)
Arthralgia
57 (.27%)
Chest Pain
56 (.27%)
Liver Disorder
56 (.27%)
Ventricular Septal Defect
55 (.26%)
Ascites
53 (.25%)
Hyponatraemia
53 (.25%)
Live Birth
53 (.25%)
Patent Ductus Arteriosus
52 (.25%)
Urticaria
52 (.25%)
Bladder Agenesis
51 (.24%)
Chills
51 (.24%)
Respiratory Distress
51 (.24%)
Lymphoma
50 (.24%)
Pancytopenia
50 (.24%)
Gastrointestinal Malformation
49 (.23%)
Platelet Count Decreased
49 (.23%)
Premature Labour
49 (.23%)
Rash Maculo-papular
49 (.23%)
Hepatotoxicity
48 (.23%)
Respiratory Failure
48 (.23%)
Weight Increased
48 (.23%)
Cholelithiasis
47 (.23%)
Metabolic Acidosis
47 (.23%)
Rhabdomyolysis
47 (.23%)
Staphylococcal Infection
47 (.23%)
Cerebral Haemorrhage
46 (.22%)
Condition Aggravated
46 (.22%)
Abdominal Pain Upper
45 (.22%)
Erythema
45 (.22%)
Dizziness
44 (.21%)
Hypotension
44 (.21%)
Lymphadenopathy
44 (.21%)
Varices Oesophageal
44 (.21%)
Gastrointestinal Disorder
43 (.21%)
Hepatitis C
43 (.21%)

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

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

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

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

Hiv Infection
4731
Drug Exposure During Pregnancy
464
Drug Use For Unknown Indication
302
Antiretroviral Therapy
268
Product Used For Unknown Indication
184
Acquired Immunodeficiency Syndrome
181
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Maternal Exposure Timing Unspecifie...
115
Antiviral Treatment
106
Hiv Test Positive
91
Systemic Antiviral Treatment
36
Maternal Exposure During Pregnancy
36
Retroviral Infection
23
Prophylaxis Against Hiv Infection
20
Acute Hiv Infection
18
Human Immunodeficiency Virus Transm...
8
Hiv Test
8
Antiviral Prophylaxis
7
Asymptomatic Hiv Infection
6
Foetal Exposure During Pregnancy
6
Viral Infection
5
Prophylaxis
5
Hiv Infection Cdc Category B2
5
Pathogen Resistance
5
Infection
5
Hiv Infection Cdc Category A3
3
Ill-defined Disorder
3
Intentional Drug Misuse
3
Hypertension
2
Self Injurious Behaviour
2
Herpes Simplex
2
Hepatitis C Virus Test
2
Exposure To Communicable Disease
2
Hiv Infection Cdc Category A2
2
Kaposis Sarcoma Aids Related
2
Hiv Infection Cdc Category B3
2
Hiv Infection Cdc Category A1
2
Asthma
1
Kaposis Sarcoma
1
Accidental Exposure
1
Autoimmune Disorder
1
Supplementation Therapy
1
Hiv Infection Cdc Group Iv Subgroup...
1
Drug Interaction
1
Paternal Drugs Affecting Foetus
1
Hiv Infection Cdc Category C2
1
Drug Therapy
1
Enzyme Abnormality
1
Urticaria
1
Hiv Infection Cdc Category C3
1
Systemic Antifungal Treatment
1
Antifungal Prophylaxis
1

Drug Labels

LabelLabelerEffective
NorvirAbbott Laboratories28-NOV-12
NorvirAbbott Laboratories30-NOV-12
NorvirAbbVie Inc.23-APR-13

Norvir Case Reports

What Norvir 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 Norvir. 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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