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Inlyta Adverse Events Reported to the FDA Over Time

How are Inlyta adverse event reports trending over time?

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

Most Common Inlyta Adverse Events Reported to the FDA

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

Fatigue
47 (5.8%)
Death
38 (4.69%)
Disease Progression
36 (4.44%)
Decreased Appetite
28 (3.46%)
Diarrhoea
27 (3.33%)
Dysphonia
21 (2.59%)
Weight Decreased
20 (2.47%)
Headache
18 (2.22%)
Constipation
16 (1.98%)
Renal Cancer
16 (1.98%)
Asthenia
14 (1.73%)
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Glossodynia
13 (1.6%)
Renal Cell Carcinoma
13 (1.6%)
Dyspnoea
12 (1.48%)
Hypertension
12 (1.48%)
Nausea
12 (1.48%)
Pain
12 (1.48%)
Blood Pressure Increased
10 (1.23%)
Fall
9 (1.11%)
Increased Tendency To Bruise
9 (1.11%)
Stomatitis
9 (1.11%)
Convulsion
8 (.99%)
Gait Disturbance
8 (.99%)
Dehydration
7 (.86%)
Malaise
7 (.86%)
Mental Status Changes
7 (.86%)
Pain In Extremity
7 (.86%)
Somnolence
7 (.86%)
Chest Pain
6 (.74%)
Impaired Healing
6 (.74%)
Oropharyngeal Pain
6 (.74%)
Palmar-plantar Erythrodysaesthesia ...
6 (.74%)
Amnesia
5 (.62%)
Aphasia
5 (.62%)
Aphonia
5 (.62%)
Confusional State
5 (.62%)
Contusion
5 (.62%)
Drug Intolerance
5 (.62%)
Dysarthria
5 (.62%)
General Physical Health Deteriorati...
5 (.62%)
Head Injury
5 (.62%)
Insomnia
5 (.62%)
Pneumonia
5 (.62%)
Pyrexia
5 (.62%)
Vomiting
5 (.62%)
Anxiety
4 (.49%)
Arthralgia
4 (.49%)
Back Pain
4 (.49%)
Central Nervous System Lesion
4 (.49%)
Dysgeusia
4 (.49%)
Encephalopathy
4 (.49%)
Flatulence
4 (.49%)
Food Intolerance
4 (.49%)
Mucosal Inflammation
4 (.49%)
Myalgia
4 (.49%)
Oral Fungal Infection
4 (.49%)
Rash
4 (.49%)
Abdominal Pain
3 (.37%)
Agitation
3 (.37%)
Blood Glucose Increased
3 (.37%)
Chills
3 (.37%)
Circulatory Collapse
3 (.37%)
Dizziness
3 (.37%)
Feeling Abnormal
3 (.37%)
Furuncle
3 (.37%)
Hypotension
3 (.37%)
Musculoskeletal Stiffness
3 (.37%)
Neoplasm Malignant
3 (.37%)
Night Sweats
3 (.37%)
Oedema Peripheral
3 (.37%)
Renal Haemorrhage
3 (.37%)
Respiratory Failure
3 (.37%)
Rhinorrhoea
3 (.37%)
Skin Atrophy
3 (.37%)
Skin Discolouration
3 (.37%)
Skin Exfoliation
3 (.37%)
Skin Irritation
3 (.37%)
Transient Ischaemic Attack
3 (.37%)
Urinary Incontinence
3 (.37%)
White Blood Cell Count Decreased
3 (.37%)
Acute Myocardial Infarction
2 (.25%)
Ageusia
2 (.25%)
Blister
2 (.25%)
Blood Creatinine Increased
2 (.25%)
Blood Glucose Fluctuation
2 (.25%)
Blood Magnesium Decreased
2 (.25%)
Blood Pressure Systolic Increased
2 (.25%)
Burning Sensation
2 (.25%)
Cough
2 (.25%)
Diabetes Mellitus
2 (.25%)
Dyspnoea Exertional
2 (.25%)
Dysstasia
2 (.25%)
Epistaxis
2 (.25%)
Hepatic Pain
2 (.25%)
Hyperaesthesia
2 (.25%)
Hypomagnesaemia
2 (.25%)
Hypophagia
2 (.25%)
Hypothyroidism
2 (.25%)
Inflammation
2 (.25%)
Intestinal Mass
2 (.25%)
Limb Discomfort
2 (.25%)

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

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

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

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

Renal Cancer
122
Renal Cell Carcinoma
41
Metastatic Renal Cell Carcinoma
8
Neoplasm Malignant
7
Malignant Urinary Tract Neoplasm
6
Renal Cancer Metastatic
6
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Renal Neoplasm
5
Lung Neoplasm Malignant
5
Malignant Neoplasm Of Renal Pelvis
4
Bronchial Carcinoma
3
Neoplasm
2
Renal Cancer Stage Iv
1
Adrenal Carcinoma
1
Lung Neoplasm
1
Hepatic Cancer Metastatic
1
Adrenal Disorder
1
Metastases To Liver
1
Breast Cancer
1

Drug Labels

LabelLabelerEffective
InlytaPfizer Laboratories Div Pfizer Inc26-JAN-12

Inlyta Case Reports

What Inlyta 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 Inlyta. 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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