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Lapatinib Adverse Events Reported to the FDA Over Time

How are Lapatinib adverse event reports trending over time?

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

Most Common Lapatinib Adverse Events Reported to the FDA

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

Diarrhoea
3198 (8.89%)
Nausea
1286 (3.57%)
Vomiting
1016 (2.82%)
Fatigue
948 (2.64%)
Pyrexia
713 (1.98%)
Rash
697 (1.94%)
Palmar-plantar Erythrodysaesthesia ...
652 (1.81%)
Dyspnoea
595 (1.65%)
Dehydration
594 (1.65%)
Death
560 (1.56%)
Neutropenia
470 (1.31%)
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Decreased Appetite
404 (1.12%)
Asthenia
373 (1.04%)
Abdominal Pain
356 (.99%)
Disease Progression
352 (.98%)
Dizziness
284 (.79%)
Erythema
283 (.79%)
Malaise
267 (.74%)
Febrile Neutropenia
266 (.74%)
Stomatitis
264 (.73%)
Pneumonia
248 (.69%)
Alanine Aminotransferase Increased
236 (.66%)
Weight Decreased
234 (.65%)
Pain In Extremity
233 (.65%)
Dry Skin
230 (.64%)
Pruritus
227 (.63%)
Headache
221 (.61%)
Hypokalaemia
210 (.58%)
Cough
206 (.57%)
Oedema Peripheral
196 (.54%)
Anaemia
195 (.54%)
Breast Cancer Metastatic
184 (.51%)
Abdominal Pain Upper
182 (.51%)
General Physical Health Deteriorati...
171 (.48%)
Aspartate Aminotransferase Increase...
165 (.46%)
Blood Bilirubin Increased
165 (.46%)
Pain
165 (.46%)
Drug Ineffective
162 (.45%)
Chest Pain
161 (.45%)
Constipation
155 (.43%)
Skin Chapped
149 (.41%)
Anorexia
148 (.41%)
Infection
147 (.41%)
Dyspepsia
146 (.41%)
Hypotension
145 (.4%)
Pulmonary Embolism
144 (.4%)
Mucosal Inflammation
143 (.4%)
Jaundice
141 (.39%)
Leukopenia
125 (.35%)
Metastases To Central Nervous Syste...
123 (.34%)
Pleural Effusion
116 (.32%)
Thrombocytopenia
116 (.32%)
Confusional State
115 (.32%)
Hepatic Enzyme Increased
115 (.32%)
Hepatic Function Abnormal
111 (.31%)
Ejection Fraction Decreased
110 (.31%)
Skin Exfoliation
110 (.31%)
Breast Cancer
108 (.3%)
Malignant Neoplasm Progression
108 (.3%)
Mouth Ulceration
108 (.3%)
Paraesthesia
105 (.29%)
Sepsis
105 (.29%)
Arthralgia
103 (.29%)
Convulsion
103 (.29%)
Cardiac Failure Congestive
101 (.28%)
Neoplasm Malignant
101 (.28%)
Hypoaesthesia
100 (.28%)
Paronychia
98 (.27%)
Cellulitis
97 (.27%)
Chills
96 (.27%)
White Blood Cell Count Decreased
95 (.26%)
Adverse Event
93 (.26%)
Blister
93 (.26%)
Somnolence
93 (.26%)
Epistaxis
91 (.25%)
Dysphagia
90 (.25%)
Urinary Tract Infection
89 (.25%)
Acne
87 (.24%)
Renal Failure Acute
84 (.23%)
Muscle Spasms
83 (.23%)
Interstitial Lung Disease
81 (.23%)
Fall
80 (.22%)
Gait Disturbance
80 (.22%)
Metastases To Liver
80 (.22%)
Cardiac Failure
78 (.22%)
Insomnia
78 (.22%)
Blood Creatinine Increased
76 (.21%)
Hyponatraemia
76 (.21%)
Tachycardia
76 (.21%)
Abdominal Discomfort
75 (.21%)
Blood Alkaline Phosphatase Increase...
74 (.21%)
Rash Pruritic
74 (.21%)
Back Pain
73 (.2%)
Palpitations
71 (.2%)
Neuropathy Peripheral
70 (.19%)
Oedema
70 (.19%)
Haemoglobin Decreased
69 (.19%)
Ill-defined Disorder
69 (.19%)
Renal Failure
69 (.19%)
Skin Ulcer
69 (.19%)
Skin Discolouration
68 (.19%)

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

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

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

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

Breast Cancer
5019
Drug Use For Unknown Indication
877
Breast Cancer Metastatic
866
Product Used For Unknown Indication
362
Gastric Cancer
192
Head And Neck Cancer
48
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Neoplasm
45
Malignant Glioma
39
Breast Cancer Recurrent
35
Neoplasm Malignant
31
Pancreatic Carcinoma
30
Squamous Cell Carcinoma
23
Ovarian Cancer
22
Metastases To Central Nervous Syste...
17
Colorectal Cancer
17
Inflammatory Carcinoma Of The Breas...
17
Cervix Carcinoma
15
Pancreatic Carcinoma Metastatic
13
Breast Cancer Female
13
Ependymoma
11
Non-small Cell Lung Cancer
10
Breast Neoplasm
10
Prostate Cancer
9
Brain Neoplasm
8
Adenocarcinoma
8
Lung Neoplasm Malignant
7
Adenocarcinoma Pancreas
7
Gastrooesophageal Cancer
7
Metastatic Squamous Cell Carcinoma
7
Hypopharyngeal Cancer
7
Metastatic Carcinoma Of The Bladder
6
Ovarian Epithelial Cancer
6
Breast Cancer Stage Iv
6
Metastatic Gastric Cancer
6
Metastasis
6
Glioma
6
Malignant Nervous System Neoplasm
6
Inflammatory Carcinoma Of Breast Re...
5
Lung Cancer Metastatic
5
Brain Neoplasm Malignant
5
Bladder Cancer
5
Colon Cancer
4
Transitional Cell Cancer Of The Ren...
4
Colorectal Cancer Metastatic
4
Bone Neoplasm Malignant
4
Bile Duct Cancer
3
Breast Cancer Male
3
Glioblastoma
3
Metastases To Liver
3
Anal Cancer
3
Prophylactic Chemotherapy
3

Drug Labels

LabelLabelerEffective
TykerbGlaxoSmithKline LLC19-DEC-12

Lapatinib Case Reports

What Lapatinib 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 Lapatinib. 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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