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ATAZANAVIR SULFATE

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Atazanavir Sulfate Adverse Events Reported to the FDA Over Time

How are Atazanavir Sulfate adverse event reports trending over time?

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

Most Common Atazanavir Sulfate Adverse Events Reported to the FDA

What are the most common Atazanavir Sulfate adverse events reported to the FDA?

Drug Exposure During Pregnancy
120 (4.58%)
Blood Bilirubin Increased
50 (1.91%)
Abortion Spontaneous
46 (1.76%)
Premature Baby
44 (1.68%)
Renal Failure Acute
33 (1.26%)
Drug Interaction
32 (1.22%)
Nephrolithiasis
25 (.95%)
Immune Reconstitution Syndrome
24 (.92%)
Hyperbilirubinaemia
21 (.8%)
Lipodystrophy Acquired
20 (.76%)
Pregnancy
20 (.76%)
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Pyrexia
20 (.76%)
Rash
20 (.76%)
Nausea
18 (.69%)
Hepatic Function Abnormal
17 (.65%)
Diarrhoea
16 (.61%)
Hydrocephalus
16 (.61%)
Parkinsonism
16 (.61%)
Platelet Count Decreased
15 (.57%)
Renal Impairment
15 (.57%)
Ventricular Tachycardia
15 (.57%)
Vomiting
15 (.57%)
Aspartate Aminotransferase Increase...
14 (.53%)
Diabetes Mellitus
14 (.53%)
Electrocardiogram Qt Prolonged
14 (.53%)
Patent Ductus Arteriosus
14 (.53%)
Abdominal Pain
13 (.5%)
Hepatitis
13 (.5%)
Thrombocytopenia
13 (.5%)
Torsade De Pointes
13 (.5%)
Ultrasound Antenatal Screen Abnorma...
13 (.5%)
Bronchopulmonary Dysplasia
12 (.46%)
Lipoatrophy
12 (.46%)
Microcephaly
12 (.46%)
Oedema Peripheral
12 (.46%)
Supraventricular Tachycardia
12 (.46%)
Abortion Induced
11 (.42%)
Alanine Aminotransferase Increased
11 (.42%)
Blood Triglycerides Increased
11 (.42%)
Hyperglycaemia
11 (.42%)
Malaise
11 (.42%)
Mitral Valve Incompetence
11 (.42%)
Tricuspid Valve Incompetence
11 (.42%)
Atrial Septal Defect
10 (.38%)
Hepatic Cirrhosis
10 (.38%)
Hepatomegaly
10 (.38%)
Jaundice
10 (.38%)
Melaena
10 (.38%)
Osteonecrosis
10 (.38%)
Stillbirth
10 (.38%)
Depression
9 (.34%)
Developmental Delay
9 (.34%)
Eyelid Ptosis
9 (.34%)
Left Ventricular Dysfunction
9 (.34%)
Trisomy 21
9 (.34%)
White Blood Cell Count Decreased
9 (.34%)
Acute Myocardial Infarction
8 (.31%)
Anaemia
8 (.31%)
Angina Unstable
8 (.31%)
Ascites
8 (.31%)
Bradycardia
8 (.31%)
Chest Pain
8 (.31%)
Cytomegalovirus Chorioretinitis
8 (.31%)
Dyspnoea
8 (.31%)
Gamma-glutamyltransferase Increased
8 (.31%)
Hepatic Enzyme Increased
8 (.31%)
Hepatitis C
8 (.31%)
Liver Function Test Abnormal
8 (.31%)
Maternal Drugs Affecting Foetus
8 (.31%)
Oesophageal Varices Haemorrhage
8 (.31%)
Peripheral Vascular Disorder
8 (.31%)
Renal Failure
8 (.31%)
Sepsis
8 (.31%)
Splenomegaly
8 (.31%)
Varices Oesophageal
8 (.31%)
Abdominal Distension
7 (.27%)
Acute Respiratory Distress Syndrome
7 (.27%)
Blood Creatine Phosphokinase Increa...
7 (.27%)
Cd4 Lymphocytes Decreased
7 (.27%)
Coma
7 (.27%)
Heart Disease Congenital
7 (.27%)
Intestinal Perforation
7 (.27%)
Intraventricular Haemorrhage
7 (.27%)
Liver Disorder
7 (.27%)
Lymphoma
7 (.27%)
Mycobacterium Avium Complex Infecti...
7 (.27%)
Normal Newborn
7 (.27%)
Peritonitis
7 (.27%)
Placental Disorder
7 (.27%)
Pneumonia
7 (.27%)
Retinopathy Of Prematurity
7 (.27%)
Rhabdomyolysis
7 (.27%)
Strabismus
7 (.27%)
Acute Pulmonary Oedema
6 (.23%)
Agitation
6 (.23%)
Blood Bilirubin Unconjugated Increa...
6 (.23%)
Cardiac Failure
6 (.23%)
Cardiac Murmur
6 (.23%)
Cerebrovascular Accident
6 (.23%)
Cholelithiasis
6 (.23%)
Congenital Central Nervous System A...
6 (.23%)

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

What are the most common Atazanavir Sulfate adverse events reported to the FDA?

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

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

Hiv Infection
733
Drug Exposure During Pregnancy
133
Drug Use For Unknown Indication
75
Antiretroviral Therapy
42
Acquired Immunodeficiency Syndrome
16
Systemic Antiviral Treatment
12
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Product Used For Unknown Indication
8
Prophylaxis Against Hiv Infection
8
Hiv Test Positive
7
Retroviral Infection
6
Maternal Exposure During Pregnancy
5
Lipodystrophy Acquired
5
Antiviral Treatment
3
Unevaluable Event
2
Prophylaxis
2
Hepatitis C Virus Test
2
Hepatic Cirrhosis
2
Hiv Infection Cdc Category A3
2
Drug Resistance
2
Human Immunodeficiency Virus Transm...
1
Hiv Infection Cdc Category C3
1
Maternal Exposure Timing Unspecifie...
1
Cd4 Lymphocytes Decreased
1
Chronic Hepatic Failure
1

Drug Labels

LabelLabelerEffective
ReyatazPhysicians Total Care, Inc.17-FEB-12
ReyatazREMEDYREPACK INC. 26-MAR-13
ReyatazE.R. Squibb & Sons, L.L.C.01-APR-13

Atazanavir Sulfate Case Reports

What Atazanavir Sulfate 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 Atazanavir Sulfate. 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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