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PREZISTA

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Prezista Adverse Events Reported to the FDA Over Time

How are Prezista adverse event reports trending over time?

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

Most Common Prezista Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
219 (2.65%)
Pyrexia
144 (1.74%)
Rash
134 (1.62%)
Renal Failure Acute
133 (1.61%)
Immune Reconstitution Syndrome
113 (1.36%)
Premature Baby
102 (1.23%)
Anaemia
97 (1.17%)
Drug Interaction
96 (1.16%)
Diarrhoea
89 (1.08%)
Aspartate Aminotransferase Increase...
85 (1.03%)
Nausea
85 (1.03%)
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Alanine Aminotransferase Increased
83 (1%)
Depression
61 (.74%)
Headache
56 (.68%)
Pneumonia
56 (.68%)
Abortion Spontaneous
54 (.65%)
Hepatic Failure
54 (.65%)
Hypersensitivity
54 (.65%)
Lipodystrophy Acquired
54 (.65%)
Hepatitis
51 (.62%)
Premature Labour
51 (.62%)
Vomiting
50 (.6%)
Exomphalos
47 (.57%)
Sepsis
47 (.57%)
Bladder Agenesis
44 (.53%)
Cytolytic Hepatitis
44 (.53%)
Pancreatitis
43 (.52%)
Rhabdomyolysis
43 (.52%)
Rash Maculo-papular
42 (.51%)
Myocardial Infarction
41 (.5%)
Pancytopenia
41 (.5%)
Renal Failure
39 (.47%)
Fatigue
38 (.46%)
Cloacal Exstrophy
37 (.45%)
Gamma-glutamyltransferase Increased
37 (.45%)
Hepatic Function Abnormal
37 (.45%)
Hypertension
37 (.45%)
Thrombocytopenia
37 (.45%)
Weight Decreased
37 (.45%)
Caudal Regression Syndrome
36 (.43%)
Meningomyelocele
36 (.43%)
Asthenia
35 (.42%)
Dehydration
35 (.42%)
Blood Triglycerides Increased
34 (.41%)
Liver Function Test Abnormal
34 (.41%)
Congenital Genital Malformation
33 (.4%)
Dyspnoea
33 (.4%)
Maternal Drugs Affecting Foetus
33 (.4%)
Oedema Peripheral
33 (.4%)
Blood Creatine Phosphokinase Increa...
32 (.39%)
Blood Iron Decreased
32 (.39%)
Congenital Anomaly
32 (.39%)
Weight Increased
32 (.39%)
Anal Atresia
31 (.37%)
Nephrolithiasis
31 (.37%)
Umbilical Cord Abnormality
31 (.37%)
Abdominal Pain
30 (.36%)
Diabetes Mellitus
29 (.35%)
Meconium Stain
29 (.35%)
Chest Pain
28 (.34%)
Gastrointestinal Disorder Congenita...
28 (.34%)
Genitalia External Ambiguous
28 (.34%)
Hepatotoxicity
28 (.34%)
Erythema
27 (.33%)
Stevens-johnson Syndrome
27 (.33%)
Blood Alkaline Phosphatase Increase...
26 (.31%)
Drug Rash With Eosinophilia And Sys...
26 (.31%)
Eosinophilia
26 (.31%)
Liver Disorder
26 (.31%)
Mycobacterium Avium Complex Infecti...
26 (.31%)
Osteonecrosis
26 (.31%)
Angioedema
25 (.3%)
Blood Bilirubin Increased
25 (.3%)
Cardiac Murmur
25 (.3%)
Condition Aggravated
25 (.3%)
Myalgia
25 (.3%)
Pulmonary Embolism
25 (.3%)
Deep Vein Thrombosis
24 (.29%)
Gastrointestinal Malformation
24 (.29%)
Hepatitis Cholestatic
24 (.29%)
Paraesthesia
24 (.29%)
Death
23 (.28%)
Epilepsy
23 (.28%)
Hepatic Cirrhosis
23 (.28%)
Malaise
23 (.28%)
Transaminases Increased
23 (.28%)
Ventricular Hypertrophy
23 (.28%)
Bradycardia
22 (.27%)
Drug Ineffective
22 (.27%)
Hepatitis B
22 (.27%)
Hyperbilirubinaemia
22 (.27%)
Hyperlipidaemia
22 (.27%)
Off Label Use
22 (.27%)
Pruritus
22 (.27%)
Urosepsis
22 (.27%)
Abdominal Pain Upper
21 (.25%)
Blood Amylase Increased
21 (.25%)
Jaundice
21 (.25%)
Rash Generalised
21 (.25%)
Cerebral Infarction
20 (.24%)
Hyperglycaemia
20 (.24%)

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

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

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

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

Hiv Infection
2305
Product Used For Unknown Indication
117
Drug Exposure During Pregnancy
109
Drug Use For Unknown Indication
68
Antiretroviral Therapy
56
Antiviral Treatment
49
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Acquired Immunodeficiency Syndrome
38
Hiv Test Positive
24
Maternal Exposure Timing Unspecifie...
22
Foetal Exposure During Pregnancy
8
Acute Hiv Infection
6
Maternal Exposure During Pregnancy
6
Prophylaxis Against Hiv Infection
4
Intentional Drug Misuse
3
Diabetes Mellitus
3
Kaposis Sarcoma Aids Related
2
Lentivirus Test Positive
2
Progressive Multifocal Leukoencepha...
2
Hiv Infection Cdc Category A1
2
Blood Hiv Rna
1
Asymptomatic Hiv Infection
1
Systemic Antiviral Treatment
1
Pathogen Resistance
1
Hiv Infection Cdc Category B2
1
Antiviral Prophylaxis
1
Hiv Antibody Positive
1
Hepatitis C
1
Hiv Test
1
Hiv Infection Cdc Category B3
1
Self Injurious Behaviour
1
Hepatitis B
1
Immunodeficiency
1

Drug Labels

LabelLabelerEffective
PrezistaState of Florida DOH Central Pharmacy23-AUG-10
PrezistaPhysicians Total Care, Inc.22-OCT-12
PrezistaJanssen Products LP01-MAR-13
PrezistaJanssen Products LP01-APR-13

Prezista Case Reports

What Prezista 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 Prezista. 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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