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Invirase Adverse Events Reported to the FDA Over Time

How are Invirase adverse event reports trending over time?

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

Most Common Invirase Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
90 (5.13%)
Alpha 1 Foetoprotein Increased
34 (1.94%)
Normal Newborn
31 (1.77%)
Renal Failure Acute
29 (1.65%)
Laboratory Test Abnormal
25 (1.42%)
Hypokalaemia
22 (1.25%)
Drug Interaction
20 (1.14%)
Thrombocytopenia
20 (1.14%)
Trisomy 21
20 (1.14%)
Pruritus
19 (1.08%)
Dyspnoea
17 (.97%)
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Pregnancy
16 (.91%)
Spastic Paraplegia
15 (.85%)
Spinal Cord Disorder
15 (.85%)
Vitamin B12 Deficiency
15 (.85%)
Convulsion
13 (.74%)
Renal Failure
13 (.74%)
Subacute Combined Cord Degeneration
13 (.74%)
Alpha 1 Foetoprotein Abnormal
12 (.68%)
Premature Baby
12 (.68%)
Stevens-johnson Syndrome
12 (.68%)
Congenital Anomaly
11 (.63%)
Dysphagia
11 (.63%)
Glycosuria
11 (.63%)
Hypophosphataemia
11 (.63%)
Nephrocalcinosis
11 (.63%)
Proteinuria
11 (.63%)
Renal Failure Chronic
11 (.63%)
Dehydration
10 (.57%)
General Physical Health Deteriorati...
10 (.57%)
Nausea
10 (.57%)
Pyrexia
10 (.57%)
Vomiting
10 (.57%)
Anaemia
9 (.51%)
Asthenia
9 (.51%)
Fanconi Syndrome
9 (.51%)
Keratitis
9 (.51%)
Myocardial Infarction
9 (.51%)
Oesophageal Atresia
9 (.51%)
Urticaria
9 (.51%)
Weight Decreased
9 (.51%)
Abortion Spontaneous
8 (.46%)
Arthralgia
8 (.46%)
Cerebrovascular Accident
8 (.46%)
Congenital Hydronephrosis
8 (.46%)
Diarrhoea
8 (.46%)
Headache
8 (.46%)
Hydronephrosis
8 (.46%)
Hyponatraemia
8 (.46%)
Hypospadias
8 (.46%)
Neutropenia
8 (.46%)
Respiratory Distress
8 (.46%)
Spine Malformation
8 (.46%)
Atrial Fibrillation
7 (.4%)
Cholestasis Of Pregnancy
7 (.4%)
Conjunctivitis
7 (.4%)
Corneal Abscess
7 (.4%)
Death
7 (.4%)
Pancytopenia
7 (.4%)
Stomatitis
7 (.4%)
Agitation
6 (.34%)
Anorexia
6 (.34%)
Coronary Artery Disease
6 (.34%)
Depression
6 (.34%)
Diaphragmatic Hernia
6 (.34%)
Dyspepsia
6 (.34%)
Eosinophilia
6 (.34%)
Fatigue
6 (.34%)
Hepatomegaly
6 (.34%)
Histiocytosis Haematophagic
6 (.34%)
Hypersensitivity
6 (.34%)
Hypertriglyceridaemia
6 (.34%)
Neuropathy Peripheral
6 (.34%)
Patent Ductus Arteriosus
6 (.34%)
Agranulocytosis
5 (.28%)
Angina Unstable
5 (.28%)
Caesarean Section
5 (.28%)
Hepatotoxicity
5 (.28%)
Hypercholesterolaemia
5 (.28%)
Immune Reconstitution Syndrome
5 (.28%)
Intra-uterine Death
5 (.28%)
Lactic Acidosis
5 (.28%)
Mucosal Inflammation
5 (.28%)
Multiple Congenital Abnormalities
5 (.28%)
Myalgia
5 (.28%)
Platelet Count Decreased
5 (.28%)
Unevaluable Event
5 (.28%)
Abdominal Distension
4 (.23%)
Aids Encephalopathy
4 (.23%)
Aplastic Anaemia
4 (.23%)
Arteriovenous Malformation
4 (.23%)
Back Pain
4 (.23%)
Blood Pressure Systolic Decreased
4 (.23%)
Bone Pain
4 (.23%)
Cardiac Failure
4 (.23%)
Cephalhaematoma
4 (.23%)
Cerebral Haemorrhage
4 (.23%)
Coma
4 (.23%)
Congenital Nail Disorder
4 (.23%)
Diabetes Mellitus
4 (.23%)
Drug Hypersensitivity
4 (.23%)

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

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

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

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

Hiv Infection
404
Drug Use For Unknown Indication
60
Drug Exposure During Pregnancy
29
Acquired Immunodeficiency Syndrome
28
Product Used For Unknown Indication
21
Systemic Antiviral Treatment
15
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Antiretroviral Therapy
12
Hiv Test Positive
9
Antiviral Treatment
5
Cd4 Lymphocytes Decreased
5
Infection
4
Maternal Exposure During Pregnancy
3
Prophylaxis Against Hiv Infection
2
Acute Hiv Infection
2
Drug Intolerance
1
Anti-infective Therapy
1
Hiv Infection Cdc Group Iv Subgroup...
1
Maternal Exposure Timing Unspecifie...
1

Drug Labels

LabelLabelerEffective
InviraseState of Florida DOH Central Pharmacy20-SEP-10
InviraseGenentech, Inc.30-NOV-12
InviraseREMEDYREPACK INC. 01-MAY-13

Invirase Case Reports

What Invirase 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 Invirase. 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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