DrugCite
Search

HERCEPTIN

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Herceptin Adverse Events Reported to the FDA Over Time

How are Herceptin adverse event reports trending over time?

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

Most Common Herceptin Adverse Events Reported to the FDA

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

Diarrhoea
352 (1.68%)
Disease Progression
327 (1.56%)
Dyspnoea
318 (1.51%)
Ejection Fraction Decreased
285 (1.36%)
Pyrexia
274 (1.31%)
Neutropenia
257 (1.22%)
Nausea
253 (1.2%)
Vomiting
241 (1.15%)
Death
217 (1.03%)
Fatigue
214 (1.02%)
Febrile Neutropenia
204 (.97%)
Show More Show More
Dehydration
167 (.8%)
Anaemia
163 (.78%)
Cardiomyopathy
151 (.72%)
White Blood Cell Count Decreased
150 (.71%)
Myocarditis
144 (.69%)
Cardiac Failure
137 (.65%)
Palmar-plantar Erythrodysaesthesia ...
134 (.64%)
Thrombocytopenia
133 (.63%)
Malignant Neoplasm Progression
132 (.63%)
Asthenia
129 (.61%)
Interstitial Lung Disease
129 (.61%)
Pneumonia
127 (.6%)
Chest Pain
122 (.58%)
Metastases To Central Nervous Syste...
119 (.57%)
Haemoglobin Decreased
114 (.54%)
Chills
113 (.54%)
Pulmonary Embolism
113 (.54%)
Abdominal Pain
112 (.53%)
Sepsis
109 (.52%)
Hypotension
108 (.51%)
Infusion Related Reaction
108 (.51%)
Oedema Peripheral
108 (.51%)
Rash
107 (.51%)
Tachycardia
107 (.51%)
Myocardial Infarction
106 (.5%)
Headache
105 (.5%)
Cardiac Disorder
104 (.5%)
Alanine Aminotransferase Increased
102 (.49%)
Pleural Effusion
102 (.49%)
Drug Exposure During Pregnancy
101 (.48%)
Aspartate Aminotransferase Increase...
97 (.46%)
Cardiac Failure Congestive
95 (.45%)
Malaise
95 (.45%)
Dizziness
94 (.45%)
Pain
94 (.45%)
Myalgia
92 (.44%)
Hypertension
88 (.42%)
Renal Failure
83 (.4%)
Leukopenia
78 (.37%)
Renal Failure Acute
78 (.37%)
Syncope
77 (.37%)
Arthralgia
76 (.36%)
Erythema
76 (.36%)
Stomatitis
76 (.36%)
Mucosal Inflammation
74 (.35%)
Platelet Count Decreased
74 (.35%)
Hypersensitivity
73 (.35%)
Infection
73 (.35%)
Pruritus
73 (.35%)
Pericardial Effusion
72 (.34%)
Alopecia
71 (.34%)
Palpitations
67 (.32%)
Neuropathy Peripheral
65 (.31%)
General Physical Health Deteriorati...
64 (.3%)
Metastases To Liver
64 (.3%)
Convulsion
63 (.3%)
Cough
63 (.3%)
Neutrophil Count Decreased
63 (.3%)
Blood Creatinine Increased
61 (.29%)
Chest Discomfort
61 (.29%)
Hepatic Failure
61 (.29%)
Drug Ineffective
60 (.29%)
Mitral Valve Incompetence
60 (.29%)
Respiratory Failure
60 (.29%)
Acute Myeloid Leukaemia
59 (.28%)
Blood Alkaline Phosphatase Increase...
58 (.28%)
Breast Cancer
58 (.28%)
Atrial Fibrillation
53 (.25%)
Neutropenic Sepsis
53 (.25%)
Pancytopenia
53 (.25%)
Pulmonary Oedema
53 (.25%)
Tremor
52 (.25%)
Disseminated Intravascular Coagulat...
51 (.24%)
Hypokalaemia
51 (.24%)
Left Ventricular Dysfunction
50 (.24%)
Paraesthesia
50 (.24%)
Pulmonary Hypertension
50 (.24%)
Weight Decreased
50 (.24%)
Epistaxis
49 (.23%)
Metastases To Lung
49 (.23%)
Pain In Extremity
49 (.23%)
Blood Bilirubin Increased
48 (.23%)
Decreased Appetite
48 (.23%)
Depression
48 (.23%)
Hypoxia
48 (.23%)
Oedema
48 (.23%)
Pulmonary Fibrosis
48 (.23%)
Skin Exfoliation
48 (.23%)
Cardiac Arrest
47 (.22%)
Hypoaesthesia
47 (.22%)

ExportShare/Embed GraphExport Export Data

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

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

Show More Show More

ExportShare/Embed Graph Export Export Data

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

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

Breast Cancer
3430
Breast Cancer Metastatic
1404
Drug Use For Unknown Indication
391
Product Used For Unknown Indication
252
Gastric Cancer
116
Breast Cancer Recurrent
55
Show More Show More
Metastatic Gastric Cancer
47
Metastases To Bone
30
Neoplasm Malignant
27
Breast Cancer Female
25
Breast Neoplasm
21
Chemotherapy
20
Metastatic Neoplasm
15
Transitional Cell Carcinoma
14
Inflammatory Carcinoma Of The Breas...
14
Bladder Cancer
13
Gastric Cancer Recurrent
12
Breast Cancer In Situ
11
Metastases To Liver
10
Metastases To Lymph Nodes
9
Breast Cancer Stage Iii
9
Oesophageal Adenocarcinoma
8
Non-small Cell Lung Cancer
7
Adjuvant Therapy
7
Ovarian Cancer
7
Breast Cancer Stage Iv
7
Neoplasm
5
Oesophageal Cancer Metastatic
5
Monoclonal Antibody Unconjugated Th...
5
Gastrooesophageal Cancer
4
Lung Neoplasm Malignant
4
Breast Cancer Stage Ii
4
Breast Cancer Stage I
4
Adenocarcinoma
4
Therapeutic Procedure
4
Metastases To Lung
3
Ill-defined Disorder
3
Metastasis
3
Pancreatic Carcinoma
3
Osteosarcoma Metastatic
3
Unevaluable Event
3
Drug Exposure During Pregnancy
3
Hypercalcaemia Of Malignancy
2
Acute Lymphocytic Leukaemia
2
Colorectal Cancer
2
Bone Neoplasm Malignant
2
Endometrial Cancer Recurrent
2
Carcinoma
2
Inflammatory Carcinoma Of Breast St...
2
Tongue Neoplasm Malignant Stage Uns...
2
Uterine Cancer
2

Drug Labels

LabelLabelerEffective
HerceptinGenentech, Inc.26-OCT-10

Herceptin Case Reports

What Herceptin safety concerns are being reported by doctors and researchers in the medical literature?

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Herceptin. 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.

Comments

Share your experience with Herceptin.