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LOPINAVIR AND RITONAVIR

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Lopinavir And Ritonavir Adverse Events Reported to the FDA Over Time

How are Lopinavir And Ritonavir adverse event reports trending over time?

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

Most Common Lopinavir And Ritonavir Adverse Events Reported to the FDA

What are the most common Lopinavir And Ritonavir adverse events reported to the FDA?

Immune Reconstitution Syndrome
105 (2.51%)
Drug Exposure During Pregnancy
94 (2.25%)
Drug Interaction
79 (1.89%)
Diarrhoea
52 (1.24%)
Premature Baby
51 (1.22%)
Vomiting
51 (1.22%)
Atrioventricular Block Complete
46 (1.1%)
Pyrexia
44 (1.05%)
Lipodystrophy Acquired
41 (.98%)
Anaemia
34 (.81%)
Renal Failure Acute
32 (.76%)
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Abortion Spontaneous
31 (.74%)
Headache
27 (.64%)
Pregnancy
27 (.64%)
Eyelid Ptosis
26 (.62%)
Nausea
25 (.6%)
Sepsis
25 (.6%)
Death
24 (.57%)
Alanine Aminotransferase Increased
23 (.55%)
Congestive Cardiomyopathy
23 (.55%)
Dehydration
23 (.55%)
Weight Decreased
23 (.55%)
Asthenia
21 (.5%)
Cardiomyopathy
21 (.5%)
Diplopia
21 (.5%)
Fatigue
21 (.5%)
Mitochondrial Toxicity
21 (.5%)
Abdominal Pain
20 (.48%)
Hepatotoxicity
20 (.48%)
Thrombocytopenia
20 (.48%)
Blood Creatinine Increased
19 (.45%)
Gastroenteritis
19 (.45%)
Maternal Drugs Affecting Foetus
19 (.45%)
Pancytopenia
19 (.45%)
Stillbirth
19 (.45%)
Aspartate Aminotransferase Increase...
18 (.43%)
Blood Alkaline Phosphatase Increase...
18 (.43%)
Pneumonia
18 (.43%)
Premature Rupture Of Membranes
18 (.43%)
Progressive External Ophthalmoplegi...
18 (.43%)
Drug Toxicity
17 (.41%)
Gamma-glutamyltransferase Increased
17 (.41%)
Neutropenia
17 (.41%)
Premature Labour
17 (.41%)
Renal Failure
17 (.41%)
Abdominal Distension
16 (.38%)
Condition Aggravated
16 (.38%)
Haemoglobin Decreased
16 (.38%)
Hypotension
16 (.38%)
Neuropathy Peripheral
16 (.38%)
Cardiac Murmur
15 (.36%)
Hepatic Failure
15 (.36%)
Intra-uterine Death
15 (.36%)
Pallor
15 (.36%)
Dyspnoea
14 (.33%)
Osteonecrosis
14 (.33%)
Platelet Count Decreased
14 (.33%)
Tachycardia
14 (.33%)
Congenital Anomaly
13 (.31%)
Decreased Appetite
13 (.31%)
Hepatomegaly
13 (.31%)
Jaundice
13 (.31%)
Lymphadenopathy
13 (.31%)
Nephropathy Toxic
13 (.31%)
Confusional State
12 (.29%)
Cough
12 (.29%)
Dizziness
12 (.29%)
Hepatitis
12 (.29%)
Myocardial Infarction
12 (.29%)
Oedema Peripheral
12 (.29%)
Pulmonary Tuberculosis
12 (.29%)
Ascites
11 (.26%)
Lactic Acidosis
11 (.26%)
Lymphadenitis
11 (.26%)
Meningitis Cryptococcal
11 (.26%)
Palpitations
11 (.26%)
Respiratory Failure
11 (.26%)
Adrenal Insufficiency
10 (.24%)
Chest Pain
10 (.24%)
Depression
10 (.24%)
General Physical Health Deteriorati...
10 (.24%)
Hepatic Encephalopathy
10 (.24%)
Hepatitis B
10 (.24%)
Hypersensitivity
10 (.24%)
Hypertension
10 (.24%)
Myalgia
10 (.24%)
Oral Candidiasis
10 (.24%)
Pancreatitis
10 (.24%)
Patent Ductus Arteriosus
10 (.24%)
Upper Respiratory Tract Infection
10 (.24%)
Abortion Induced
9 (.21%)
Aids Encephalopathy
9 (.21%)
Blood Hiv Rna Increased
9 (.21%)
Blood Sodium Decreased
9 (.21%)
Caesarean Section
9 (.21%)
Drug Resistance
9 (.21%)
Electrocardiogram Qt Prolonged
9 (.21%)
Malaise
9 (.21%)
Malaria
9 (.21%)
Oedema
9 (.21%)
Rash Maculo-papular
9 (.21%)

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This graph shows the top adverse events submitted to the FDA for Lopinavir And Ritonavir, 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 Lopinavir And Ritonavir 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 Lopinavir And Ritonavir

What are the most common Lopinavir And Ritonavir adverse events reported to the FDA?

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

Why are people taking Lopinavir And Ritonavir, according to those reporting adverse events to the FDA?

Hiv Infection
873
Antiretroviral Therapy
47
Drug Use For Unknown Indication
45
Prophylaxis Against Hiv Infection
41
Drug Exposure During Pregnancy
30
Product Used For Unknown Indication
23
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Acquired Immunodeficiency Syndrome
21
Antiviral Prophylaxis
17
Maternal Exposure Timing Unspecifie...
13
Systemic Antiviral Treatment
10
Maternal Exposure During Pregnancy
9
Hiv Test Positive
8
Viral Infection
6
Antiviral Treatment
6
Human Immunodeficiency Virus Transm...
4
Exposure During Breast Feeding
4
Malaria Prophylaxis
3
Hiv Infection Cdc Category A1
3
Pregnancy
3
Retroviral Infection
3
Foetal Exposure During Pregnancy
2
Cd4 Lymphocytes Decreased
2
Prophylaxis
2
Hiv Infection Cdc Category B3
1
Acute Hiv Infection
1
Kaposis Sarcoma
1
Drug Level
1
Mycobacterium Avium Complex Infecti...
1
Hepatitis B
1
Congenital Hiv Infection
1
Hiv Infection Cdc Category B2
1
Antifungal Prophylaxis
1
Progressive Multifocal Leukoencepha...
1

Drug Labels

LabelLabelerEffective
KaletraState of Florida DOH Central Pharmacy13-APR-10
KaletraREMEDYREPACK INC. 27-SEP-10
KaletraRebel Distributors Corp28-DEC-10
KaletraPD-Rx Pharmaceuticals, Inc.03-MAR-11
KaletraHHS/Program Support Center/Supply Service Center06-MAR-12
KaletraPhysicians Total Care, Inc.06-APR-12
KaletraDispensing Solutions, Inc.10-OCT-12
KaletraDispensing Solutions, Inc.10-OCT-12
KaletraAbbVie Inc.28-JAN-13
KaletraCardinal Health14-MAR-13

Lopinavir And Ritonavir Case Reports

What Lopinavir And Ritonavir 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 Lopinavir And Ritonavir. 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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