ACTIVELLA

Activella Adverse Events Reported to the FDA Over Time

How are Activella adverse event reports trending over time?

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

Most Common Activella Adverse Events Reported to the FDA

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

Breast Cancer	178 (28.53%)
Breast Cancer Female	131 (20.99%)
Breast Cancer Metastatic	28 (4.49%)
Breast Cancer In Situ	9 (1.44%)
Cerebrovascular Accident	9 (1.44%)
Endometrial Cancer	8 (1.28%)
Pain	8 (1.28%)
Deep Vein Thrombosis	7 (1.12%)
Pulmonary Embolism	7 (1.12%)
Anxiety	6 (.96%)
Breast Disorder	6 (.96%)
	Show More
Drug Dispensing Error	6 (.96%)
Hepatic Steatosis	6 (.96%)
Benign Breast Neoplasm	5 (.8%)
Nausea	5 (.8%)
Pain In Extremity	5 (.8%)
Breast Mass	4 (.64%)
Marital Problem	4 (.64%)
Myocardial Infarction	4 (.64%)
Neoplasm Malignant	4 (.64%)
Oedema Peripheral	4 (.64%)
Vision Blurred	4 (.64%)
Breast Lump Removal	3 (.48%)
Depression	3 (.48%)
Diarrhoea	3 (.48%)
Mastectomy	3 (.48%)
Muscle Spasms	3 (.48%)
Osteoarthritis	3 (.48%)
Venous Thrombosis	3 (.48%)
Abdominal Pain	2 (.32%)
Arteriosclerosis	2 (.32%)
Asthenia	2 (.32%)
Back Pain	2 (.32%)
Breast Operation	2 (.32%)
Bronchitis	2 (.32%)
Cataract	2 (.32%)
Constipation	2 (.32%)
Coronary Artery Disease	2 (.32%)
Cutaneous Sarcoidosis	2 (.32%)
Dermal Cyst	2 (.32%)
Drug Ineffective For Unapproved Ind...	2 (.32%)
Dyspepsia	2 (.32%)
Endometrial Cancer Stage Ii	2 (.32%)
Erythema	2 (.32%)
Fatigue	2 (.32%)
Feeling Abnormal	2 (.32%)
Fibroadenoma Of Breast	2 (.32%)
Fibrocystic Breast Disease	2 (.32%)
Folliculitis	2 (.32%)
Gastroenteritis	2 (.32%)
Gastrooesophageal Reflux Disease	2 (.32%)
Groin Pain	2 (.32%)
Hot Flush	2 (.32%)
Hypercholesterolaemia	2 (.32%)
Lymphoedema	2 (.32%)
Medication Error	2 (.32%)
Musculoskeletal Discomfort	2 (.32%)
Oestrogen Receptor Assay Positive	2 (.32%)
Palpitations	2 (.32%)
Papillary Serous Endometrial Carcin...	2 (.32%)
Product Label Confusion	2 (.32%)
Product Label Issue	2 (.32%)
Product Substitution Issue	2 (.32%)
Scleroderma	2 (.32%)
Spinal Osteoarthritis	2 (.32%)
Tendonitis	2 (.32%)
Tinea Infection	2 (.32%)
Abdominal Discomfort	1 (.16%)
Abdominal Pain Upper	1 (.16%)
Alopecia	1 (.16%)
Amnesia	1 (.16%)
Anhedonia	1 (.16%)
Arthralgia	1 (.16%)
Arthritis	1 (.16%)
Atrial Fibrillation	1 (.16%)
Bipolar Disorder	1 (.16%)
Blister	1 (.16%)
Blood Glucose Decreased	1 (.16%)
Breast Cancer Stage Ii	1 (.16%)
Breast Swelling	1 (.16%)
Caustic Injury	1 (.16%)
Chromaturia	1 (.16%)
Colitis Ischaemic	1 (.16%)
Condition Aggravated	1 (.16%)
Cutaneous Lupus Erythematosus	1 (.16%)
Cytolytic Hepatitis	1 (.16%)
Death	1 (.16%)
Dementia	1 (.16%)
Disease Recurrence	1 (.16%)
Drug Ineffective	1 (.16%)
Dysarthria	1 (.16%)
Dyspnoea	1 (.16%)
Ecchymosis	1 (.16%)
Endometrial Hyperplasia	1 (.16%)
Gastric Disorder	1 (.16%)
Gastric Polyps	1 (.16%)
Haemorrhage	1 (.16%)
Headache	1 (.16%)
Heart Rate Increased	1 (.16%)
Hepatitis A Antibody Positive	1 (.16%)
Hypersensitivity	1 (.16%)

Share/Embed Graph Export Data

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

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

Breast Neoplasms Malignant And Unsp...	347 (55.61%)
Breast	13 (2.08%)
Reproductive Neoplasms Female Malig...	13 (2.08%)
Musculoskeletal And Connective Tiss...	12 (1.92%)
Gastrointestinal Signs	11 (1.76%)
Central Nervous System Vascular	10 (1.6%)
Embolism And Thrombosis	10 (1.6%)
Hepatic And Hepatobiliary	9 (1.44%)
Medication Errors	9 (1.44%)
Breast Therapeutic Procedures	8 (1.28%)
Epidermal And Dermal Conditions	8 (1.28%)
	Show More
Gastrointestinal Motility And Defec...	8 (1.28%)
Joint	8 (1.28%)
Product Quality Issues	8 (1.28%)
Breast Neoplasms Benign	7 (1.12%)
Pulmonary Vascular	7 (1.12%)
Anxiety Disorders	6 (.96%)
Coronary Artery	6 (.96%)
Infections - Pathogen Unspecified	6 (.96%)
Miscellaneous And Site Unspecified ...	6 (.96%)
Vision	5 (.8%)
Depressed Mood Disorders	4 (.64%)
Family Issues	4 (.64%)
Muscle	4 (.64%)
Neurological	4 (.64%)
Therapeutic And Nontherapeutic Effe...	4 (.64%)
Vulvovaginal Disorders	4 (.64%)
Connective Tissue Disorders	3 (.48%)
Endocrine Investigations	3 (.48%)
Skin Appendage Conditions	3 (.48%)
Anterior Eye Structural Change, Dep...	2 (.32%)
Arteriosclerosis, Stenosis, Vascula...	2 (.32%)
Bacterial Infectious	2 (.32%)
Cardiac Disorder Signs	2 (.32%)
Cutaneous Neoplasms Benign	2 (.32%)
Fungal Infectious	2 (.32%)
Lipid Metabolism	2 (.32%)
Lymphatic Vessel	2 (.32%)
Mental Impairment	2 (.32%)
Skin Vascular Abnormalities	2 (.32%)
Tendon, Ligament And Cartilage	2 (.32%)
Vascular	2 (.32%)
Allergic Conditions	1 (.16%)
Benign Neoplasms Gastrointestinal	1 (.16%)
Body Temperature Conditions	1 (.16%)
Cardiac And Vascular Investigations	1 (.16%)
Cardiac Arrhythmias	1 (.16%)
Chemical Injury And Poisoning	1 (.16%)
Fatal Outcomes	1 (.16%)
Gastrointestinal Conditions	1 (.16%)
Gastrointestinal Inflammatory Condi...	1 (.16%)
Gastrointestinal Vascular Condition...	1 (.16%)
Headaches	1 (.16%)
Hematology Investigations	1 (.16%)
Hepatobiliary	1 (.16%)
Injuries	1 (.16%)
Manic And Bipolar Mood Disorders	1 (.16%)
Metabolic, Nutritional And Blood Ga...	1 (.16%)
Microbiology And Serology	1 (.16%)
Musculoskeletal And Connective Tiss...	1 (.16%)
Ovarian And Fallopian Tube	1 (.16%)
Physical Examination Topics	1 (.16%)
Respiratory	1 (.16%)
Retina, Choroid And Vitreous Hemorr...	1 (.16%)
Sleep Disorders	1 (.16%)
Spleen, Lymphatic And Reticulendoth...	1 (.16%)
Suicidal And Self-injurious Behavio...	1 (.16%)
Therapeutic Procedures And Supporti...	1 (.16%)
Urinary Tract Signs	1 (.16%)
Uterine, Pelvic And Broad Ligament	1 (.16%)
Vascular Hemorrhagic	1 (.16%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Activella, 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 Activella 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.