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ATAZANAVIR

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Atazanavir Adverse Events Reported to the FDA Over Time

How are Atazanavir adverse event reports trending over time?

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

Most Common Atazanavir Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
192 (2.69%)
Pregnancy
134 (1.87%)
Drug Interaction
107 (1.5%)
Blood Bilirubin Increased
106 (1.48%)
Abortion Spontaneous
97 (1.36%)
Renal Failure Acute
90 (1.26%)
Hyperbilirubinaemia
87 (1.22%)
Immune Reconstitution Syndrome
76 (1.06%)
Jaundice
71 (.99%)
Caesarean Section
70 (.98%)
Premature Baby
69 (.97%)
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Aspartate Aminotransferase Increase...
66 (.92%)
Vomiting
64 (.9%)
Nephrolithiasis
63 (.88%)
Alanine Aminotransferase Increased
62 (.87%)
Normal Newborn
60 (.84%)
Nausea
58 (.81%)
Pyrexia
53 (.74%)
Diarrhoea
50 (.7%)
Rash
48 (.67%)
Headache
47 (.66%)
Renal Failure
43 (.6%)
Lipodystrophy Acquired
37 (.52%)
Gamma-glutamyltransferase Increased
36 (.5%)
Renal Impairment
36 (.5%)
Thrombocytopenia
34 (.48%)
Abdominal Pain
33 (.46%)
Parkinsonism
32 (.45%)
Pneumonia
32 (.45%)
Pancreatitis
31 (.43%)
Rhabdomyolysis
31 (.43%)
Diabetes Mellitus
30 (.42%)
Sepsis
30 (.42%)
Blood Creatine Phosphokinase Increa...
29 (.41%)
Electrocardiogram Qt Prolonged
29 (.41%)
Anaemia
28 (.39%)
Weight Decreased
28 (.39%)
Hepatitis
27 (.38%)
Hydrocephalus
27 (.38%)
Malaise
27 (.38%)
Platelet Count Decreased
27 (.38%)
Blood Bilirubin Unconjugated Increa...
25 (.35%)
Congenital Teratoma
25 (.35%)
Oedema Peripheral
24 (.34%)
Renal Colic
24 (.34%)
Stillbirth
24 (.34%)
Ultrasound Antenatal Screen Abnorma...
24 (.34%)
Blood Alkaline Phosphatase Increase...
23 (.32%)
Dyspnoea
23 (.32%)
Hepatic Function Abnormal
23 (.32%)
Hypokalaemia
23 (.32%)
Ocular Icterus
23 (.32%)
Acute Myocardial Infarction
22 (.31%)
Lipoatrophy
22 (.31%)
Renal Tubular Necrosis
22 (.31%)
Hepatic Enzyme Increased
21 (.29%)
Myalgia
21 (.29%)
Torsade De Pointes
21 (.29%)
Ventricular Tachycardia
21 (.29%)
Asthenia
20 (.28%)
Liver Function Test Abnormal
20 (.28%)
Neuropathy Peripheral
20 (.28%)
Depression
19 (.27%)
Fatigue
19 (.27%)
Myocardial Infarction
19 (.27%)
Osteonecrosis
19 (.27%)
Blood Triglycerides Increased
18 (.25%)
Hyperglycaemia
18 (.25%)
White Blood Cell Count Decreased
18 (.25%)
Cholestasis
17 (.24%)
Convulsion
17 (.24%)
Cytomegalovirus Chorioretinitis
17 (.24%)
Haematuria
17 (.24%)
Haemolytic Anaemia
17 (.24%)
Hepatitis C
17 (.24%)
Abortion Induced
16 (.22%)
Arrhythmia
16 (.22%)
Back Pain
16 (.22%)
Cerebrovascular Accident
16 (.22%)
Condition Aggravated
16 (.22%)
Hepatic Cirrhosis
16 (.22%)
Hyponatraemia
16 (.22%)
Nephropathy Toxic
16 (.22%)
Overdose
16 (.22%)
Patent Ductus Arteriosus
16 (.22%)
Respiratory Failure
16 (.22%)
Blood Antidiuretic Hormone Increase...
15 (.21%)
Cardiac Failure
15 (.21%)
Chest Pain
15 (.21%)
Death
15 (.21%)
Dehydration
15 (.21%)
Hepatic Failure
15 (.21%)
Hyperlipidaemia
15 (.21%)
Melaena
15 (.21%)
Myoglobin Blood Increased
15 (.21%)
Myositis
15 (.21%)
Pancytopenia
15 (.21%)
Respiratory Distress
15 (.21%)
Small For Dates Baby
15 (.21%)
Somnolence
15 (.21%)
Splenomegaly
15 (.21%)

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

What are the most common Atazanavir 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, 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 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 According to Those Reporting Adverse Events

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

Hiv Infection
2257
Drug Exposure During Pregnancy
168
Drug Use For Unknown Indication
112
Antiretroviral Therapy
101
Product Used For Unknown Indication
51
Acquired Immunodeficiency Syndrome
50
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Hiv Test Positive
18
Prophylaxis Against Hiv Infection
16
Systemic Antiviral Treatment
15
Maternal Exposure During Pregnancy
11
Maternal Exposure Timing Unspecifie...
7
Retroviral Infection
7
Lipodystrophy Acquired
6
Antiviral Treatment
6
Prophylaxis
4
Lentivirus Test Positive
4
Unevaluable Event
2
Hiv Infection Cdc Category A3
2
Hepatitis C Virus Test
2
Urticaria
2
Hepatitis B
2
Immunosuppression
2
Hepatic Cirrhosis
2
Drug Resistance
2
Anxiety
1
Hiv Infection Cdc Category A2
1
Cd4 Lymphocytes Decreased
1
Human Immunodeficiency Virus Transm...
1
Hiv Infection Cdc Category C3
1
Autoimmune Disorder
1
Chronic Hepatic Failure
1
Kaposis Sarcoma
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 Case Reports

What Atazanavir 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. 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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