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Zytiga Adverse Events Reported to the FDA Over Time

How are Zytiga adverse event reports trending over time?

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

Most Common Zytiga Adverse Events Reported to the FDA

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

Anaemia
130 (2.08%)
Dyspnoea
125 (2%)
Fatigue
123 (1.97%)
Prostatic Specific Antigen Increase...
122 (1.95%)
Vomiting
122 (1.95%)
Pulmonary Embolism
91 (1.46%)
Hypokalaemia
87 (1.39%)
Pyrexia
86 (1.38%)
Decreased Appetite
85 (1.36%)
Asthenia
84 (1.34%)
Nausea
84 (1.34%)
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Dehydration
81 (1.3%)
Death
78 (1.25%)
Drug Ineffective
77 (1.23%)
Oedema Peripheral
76 (1.22%)
Disease Progression
70 (1.12%)
Pneumonia
68 (1.09%)
Pain
66 (1.06%)
Thrombocytopenia
64 (1.02%)
Back Pain
61 (.98%)
Confusional State
61 (.98%)
Sepsis
60 (.96%)
Bone Pain
58 (.93%)
Renal Failure
57 (.91%)
Diarrhoea
55 (.88%)
Pleural Effusion
55 (.88%)
Weight Decreased
55 (.88%)
General Physical Health Deteriorati...
54 (.86%)
Prostate Cancer
54 (.86%)
Weight Increased
54 (.86%)
Hypotension
52 (.83%)
Prostate Cancer Metastatic
49 (.78%)
Renal Failure Acute
47 (.75%)
Blood Alkaline Phosphatase Increase...
46 (.74%)
Somnolence
43 (.69%)
Urinary Tract Infection
43 (.69%)
Dizziness
41 (.66%)
Fluid Retention
40 (.64%)
Muscular Weakness
39 (.62%)
Haemoglobin Decreased
38 (.61%)
Abdominal Pain
37 (.59%)
Constipation
36 (.58%)
Hyponatraemia
36 (.58%)
Inappropriate Schedule Of Drug Admi...
36 (.58%)
Haematuria
35 (.56%)
Alanine Aminotransferase Increased
34 (.54%)
Deep Vein Thrombosis
34 (.54%)
Malaise
34 (.54%)
Drug Interaction
33 (.53%)
Pain In Extremity
33 (.53%)
Blood Creatinine Increased
31 (.5%)
Cardiac Failure
31 (.5%)
Atrial Fibrillation
28 (.45%)
Cardiac Disorder
26 (.42%)
Feeling Jittery
26 (.42%)
Nervousness
26 (.42%)
Pruritus
26 (.42%)
Rash
26 (.42%)
Lethargy
25 (.4%)
Depressed Mood
24 (.38%)
Muscle Twitching
24 (.38%)
Restless Legs Syndrome
24 (.38%)
Jaundice
23 (.37%)
Oedema
23 (.37%)
Febrile Neutropenia
22 (.35%)
Hypersomnia
22 (.35%)
Hyperuricaemia
22 (.35%)
Infection
22 (.35%)
Neutropenia
22 (.35%)
Pancytopenia
22 (.35%)
Spinal Fracture
22 (.35%)
Breast Cancer Metastatic
21 (.34%)
Headache
21 (.34%)
Hepatic Failure
21 (.34%)
Rhabdomyolysis
21 (.34%)
Gastroenteritis
20 (.32%)
Hepatic Enzyme Increased
20 (.32%)
Liver Function Test Abnormal
20 (.32%)
Platelet Count Decreased
20 (.32%)
Respiratory Failure
20 (.32%)
Abdominal Pain Upper
19 (.3%)
Arthralgia
19 (.3%)
Spinal Cord Compression
19 (.3%)
Drug Dose Omission
18 (.29%)
Lung Infection
18 (.29%)
Malignant Pleural Effusion
18 (.29%)
Chest Discomfort
17 (.27%)
Fall
17 (.27%)
Feeling Abnormal
17 (.27%)
Pulmonary Oedema
17 (.27%)
Urinary Retention
17 (.27%)
Arrhythmia
16 (.26%)
Gamma-glutamyltransferase Increased
16 (.26%)
Hyperkalaemia
16 (.26%)
Lower Respiratory Tract Infection
16 (.26%)
Neoplasm Progression
16 (.26%)
Pneumothorax
16 (.26%)
Hepatitis
15 (.24%)
Lipase Increased
15 (.24%)
Rectal Haemorrhage
15 (.24%)
Transaminases Increased
15 (.24%)

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

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

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

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

Prostate Cancer Metastatic
808
Prostate Cancer
464
Product Used For Unknown Indication
150
Breast Cancer Metastatic
30
Ill-defined Disorder
7
Breast Cancer
5
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Prostate Cancer Stage Iv
4
Multiple Myeloma
2
Bone Neoplasm Malignant
2
Neoplasm Malignant
2
Bone Cancer Metastatic
2
Colon Cancer
1
Metastases To Bone
1
General Symptom
1
Prostatic Disorder
1
Prostate Cancer Stage Iii
1
Chemotherapy
1
Oncologic Complication
1

Drug Labels

LabelLabelerEffective
ZytigaJanssen Biotech, Inc.07-MAR-13

Zytiga Case Reports

What Zytiga 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 Zytiga. 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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