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Lexiva Adverse Events Reported to the FDA Over Time

How are Lexiva adverse event reports trending over time?

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

Most Common Lexiva Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
111 (3.45%)
Pyrexia
76 (2.36%)
Rash
65 (2.02%)
Diarrhoea
54 (1.68%)
Nausea
50 (1.55%)
Immune Reconstitution Syndrome
43 (1.34%)
Vomiting
42 (1.31%)
Abortion Spontaneous
37 (1.15%)
Malaise
34 (1.06%)
Dyspnoea
33 (1.03%)
Headache
29 (.9%)
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Fatigue
26 (.81%)
Drug Interaction
25 (.78%)
Abdominal Pain
24 (.75%)
Alanine Aminotransferase Increased
21 (.65%)
Pruritus
21 (.65%)
Anaemia
19 (.59%)
Asthenia
19 (.59%)
Cough
19 (.59%)
Lymphoma
19 (.59%)
Renal Failure Acute
19 (.59%)
Multi-organ Failure
17 (.53%)
Nephrolithiasis
17 (.53%)
Rash Maculo-papular
17 (.53%)
Renal Failure
17 (.53%)
Dizziness
16 (.5%)
Lymphadenopathy
16 (.5%)
Premature Baby
16 (.5%)
Aspartate Aminotransferase Increase...
15 (.47%)
Blood Alkaline Phosphatase Increase...
15 (.47%)
Drug Hypersensitivity
15 (.47%)
Insomnia
15 (.47%)
Myalgia
15 (.47%)
Portal Hypertension
15 (.47%)
Rash Generalised
15 (.47%)
Somnolence
15 (.47%)
Spastic Paraplegia
15 (.47%)
Spinal Cord Disorder
15 (.47%)
Vitamin B12 Deficiency
15 (.47%)
Blighted Ovum
14 (.44%)
Cd4 Lymphocytes Decreased
14 (.44%)
Confusional State
14 (.44%)
Liver Disorder
14 (.44%)
Thrombocytopenia
14 (.44%)
Depression
13 (.4%)
Gamma-glutamyltransferase Increased
13 (.4%)
Hepatic Failure
13 (.4%)
Lactic Acidosis
13 (.4%)
Pain In Extremity
13 (.4%)
Subacute Combined Cord Degeneration
13 (.4%)
Convulsion
12 (.37%)
Hypertension
12 (.37%)
Hypoxia
12 (.37%)
Jaundice
12 (.37%)
Pneumonia
12 (.37%)
Pregnancy
12 (.37%)
Weight Decreased
12 (.37%)
Abortion Missed
11 (.34%)
Drug Ineffective
11 (.34%)
Drug Toxicity
11 (.34%)
Hepatic Enzyme Increased
11 (.34%)
Hyperlactacidaemia
11 (.34%)
Trisomy 21
11 (.34%)
Back Pain
10 (.31%)
Blood Bilirubin Increased
10 (.31%)
Blood Triglycerides Increased
10 (.31%)
Cardiac Arrest
10 (.31%)
Chest Pain
10 (.31%)
Depressed Level Of Consciousness
10 (.31%)
Herpes Zoster
10 (.31%)
Hypersensitivity
10 (.31%)
Metabolic Acidosis
10 (.31%)
Nightmare
10 (.31%)
Urticaria
10 (.31%)
Blood Glucose Increased
9 (.28%)
Erythema
9 (.28%)
Hepatic Encephalopathy
9 (.28%)
Hyperbilirubinaemia
9 (.28%)
Hypertriglyceridaemia
9 (.28%)
Hypokalaemia
9 (.28%)
Lymphocyte Count Decreased
9 (.28%)
Neutropenia
9 (.28%)
Oedema Peripheral
9 (.28%)
Pneumocystis Jiroveci Pneumonia
9 (.28%)
Adrenogenital Syndrome
8 (.25%)
Aids Encephalopathy
8 (.25%)
Amnesia
8 (.25%)
Anaemia Macrocytic
8 (.25%)
Angina Unstable
8 (.25%)
Bone Marrow Failure
8 (.25%)
Condition Aggravated
8 (.25%)
Cytolytic Hepatitis
8 (.25%)
Paraesthesia Oral
8 (.25%)
Rash Erythematous
8 (.25%)
Rhabdomyolysis
8 (.25%)
Talipes
8 (.25%)
Viral Load Increased
8 (.25%)
Acidosis
7 (.22%)
Anorexia
7 (.22%)
Arthralgia
7 (.22%)
Calculus Urethral
7 (.22%)

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

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

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

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

Hiv Infection
856
Drug Use For Unknown Indication
89
Drug Exposure During Pregnancy
47
Acquired Immunodeficiency Syndrome
38
Antiretroviral Therapy
25
Hiv Test Positive
15
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Product Used For Unknown Indication
9
Systemic Antiviral Treatment
7
Antiviral Treatment
6
Prophylaxis Against Hiv Infection
5
Human Immunodeficiency Virus Transm...
5
Antiviral Prophylaxis
4
Ill-defined Disorder
3
Pneumocystis Jiroveci Infection
3
Paternal Drugs Affecting Foetus
2
Hypertension
2
Retroviral Infection
1
Medical Observation
1
Prophylaxis
1
Viral Infection
1

Drug Labels

LabelLabelerEffective
LexivaState of Florida DOH Central Pharmacy14-APR-10
LexivaGlaxoSmithKline LLC13-JUL-11
LexivaViiV Healthcare Company02-APR-13

Lexiva Case Reports

What Lexiva 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 Lexiva. 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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