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TYKERB

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Tykerb Adverse Events Reported to the FDA Over Time

How are Tykerb adverse event reports trending over time?

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

Most Common Tykerb Adverse Events Reported to the FDA

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

Diarrhoea
2231 (11.74%)
Nausea
855 (4.5%)
Fatigue
658 (3.46%)
Rash
523 (2.75%)
Palmar-plantar Erythrodysaesthesia ...
520 (2.74%)
Vomiting
518 (2.73%)
Death
500 (2.63%)
Decreased Appetite
296 (1.56%)
Dyspnoea
219 (1.15%)
Disease Progression
209 (1.1%)
Erythema
207 (1.09%)
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Dry Skin
204 (1.07%)
Asthenia
188 (.99%)
Dehydration
188 (.99%)
Pruritus
188 (.99%)
Malaise
180 (.95%)
Stomatitis
177 (.93%)
Pyrexia
170 (.89%)
Weight Decreased
164 (.86%)
Pain In Extremity
154 (.81%)
Dizziness
153 (.81%)
Skin Chapped
130 (.68%)
Drug Ineffective
127 (.67%)
Headache
121 (.64%)
Constipation
119 (.63%)
Abdominal Pain Upper
118 (.62%)
Dyspepsia
114 (.6%)
Oedema Peripheral
113 (.59%)
Breast Cancer Metastatic
109 (.57%)
Pain
104 (.55%)
Cough
103 (.54%)
Abdominal Pain
101 (.53%)
Breast Cancer
98 (.52%)
Paraesthesia
98 (.52%)
Adverse Event
92 (.48%)
Skin Exfoliation
92 (.48%)
Neoplasm Malignant
90 (.47%)
Mouth Ulceration
85 (.45%)
Acne
80 (.42%)
Blister
79 (.42%)
Hypoaesthesia
79 (.42%)
Paronychia
77 (.41%)
Metastases To Central Nervous Syste...
74 (.39%)
Epistaxis
71 (.37%)
Insomnia
70 (.37%)
Jaundice
70 (.37%)
Anorexia
69 (.36%)
Rash Pruritic
69 (.36%)
Hepatic Function Abnormal
68 (.36%)
Pneumonia
68 (.36%)
Skin Discolouration
67 (.35%)
Muscle Spasms
66 (.35%)
Blood Bilirubin Increased
64 (.34%)
Arthralgia
63 (.33%)
Convulsion
61 (.32%)
Adverse Drug Reaction
60 (.32%)
Interstitial Lung Disease
60 (.32%)
Malignant Neoplasm Progression
59 (.31%)
Ill-defined Disorder
58 (.31%)
White Blood Cell Count Decreased
58 (.31%)
Abdominal Discomfort
56 (.29%)
Metastases To Liver
54 (.28%)
Dysgeusia
53 (.28%)
Nail Disorder
52 (.27%)
Chest Pain
50 (.26%)
Gait Disturbance
50 (.26%)
Somnolence
50 (.26%)
Dermatitis Acneiform
49 (.26%)
Dysphagia
49 (.26%)
Hospitalisation
49 (.26%)
Hepatic Enzyme Increased
48 (.25%)
Oral Pain
47 (.25%)
Skin Ulcer
45 (.24%)
Back Pain
44 (.23%)
Mucosal Inflammation
41 (.22%)
Condition Aggravated
40 (.21%)
Urticaria
40 (.21%)
Fall
38 (.2%)
Hypotension
38 (.2%)
Pleural Effusion
38 (.2%)
Haemorrhage
37 (.19%)
Abdominal Distension
35 (.18%)
Chest Discomfort
35 (.18%)
Confusional State
35 (.18%)
Dry Mouth
35 (.18%)
Pulmonary Embolism
35 (.18%)
Rash Generalised
35 (.18%)
Rash Erythematous
34 (.18%)
Skin Disorder
34 (.18%)
Alopecia
33 (.17%)
Feeling Abnormal
33 (.17%)
Muscular Weakness
33 (.17%)
Neuropathy Peripheral
33 (.17%)
Palpitations
33 (.17%)
Alanine Aminotransferase Increased
32 (.17%)
Cellulitis
32 (.17%)
Flatulence
32 (.17%)
Loss Of Consciousness
32 (.17%)
Aspartate Aminotransferase Increase...
31 (.16%)
Blood Potassium Decreased
30 (.16%)
Cardiac Failure
30 (.16%)

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

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

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

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

Breast Cancer
3003
Drug Use For Unknown Indication
846
Product Used For Unknown Indication
338
Breast Cancer Metastatic
239
Breast Cancer Recurrent
34
Neoplasm Malignant
16
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Breast Cancer Female
13
Gastric Cancer
9
Brain Neoplasm
8
Neoplasm
7
Inflammatory Carcinoma Of The Breas...
6
Brain Neoplasm Malignant
5
Breast Cancer Stage Iv
5
Lung Cancer Metastatic
5
Metastasis
5
Inflammatory Carcinoma Of Breast Re...
5
Bone Neoplasm Malignant
4
Adenocarcinoma
3
Breast Cancer Male
3
Metastases To Pleura
3
Prophylactic Chemotherapy
3
Brain Cancer Metastatic
3
Colorectal Cancer
2
Metastases To Liver
2
Malignant Glioma
2
Lung Neoplasm Malignant
2
Hepatic Neoplasm
2
Breast Cancer Stage Iii
2
Renal Cancer
2
Metastases To Meninges
1
Sarcoma
1
Adrenal Carcinoma
1
Ependymoma
1
Premedication
1
Non-small Cell Lung Cancer
1
Prostate Cancer
1
Metastases To Breast
1
Ovarian Epithelial Cancer
1
Oesophageal Carcinoma
1
Prophylaxis
1
Anal Cancer
1
Metastatic Carcinoma Of The Bladder
1
Gliosarcoma
1
Ovarian Epithelial Cancer Stage Iii
1
Oesophageal Squamous Cell Carcinoma
1
Multiple Myeloma
1
Metastatic Uterine Cancer
1
Lymphoma
1
Colon Cancer
1
Ovarian Disorder
1
Metastases To Central Nervous Syste...
1

Drug Labels

LabelLabelerEffective
TykerbGlaxoSmithKline LLC19-DEC-12

Tykerb Case Reports

What Tykerb 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 Tykerb. 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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