MEGESTROL ACETATE

Megestrol Acetate Adverse Events Reported to the FDA Over Time

How are Megestrol Acetate adverse event reports trending over time?

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

Most Common Megestrol Acetate Adverse Events Reported to the FDA

What are the most common Megestrol Acetate adverse events reported to the FDA?

Death	269 (8.04%)
Deep Vein Thrombosis	152 (4.55%)
Malignant Neoplasm Progression	84 (2.51%)
Pulmonary Embolism	68 (2.03%)
Fatigue	57 (1.7%)
Asthenia	54 (1.61%)
Adrenal Insufficiency	42 (1.26%)
Oedema Peripheral	39 (1.17%)
Weight Decreased	39 (1.17%)
Dyspnoea	38 (1.14%)
Vomiting	38 (1.14%)
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Nausea	36 (1.08%)
Abdominal Pain	34 (1.02%)
Confusional State	33 (.99%)
Thrombosis	31 (.93%)
Weight Increased	28 (.84%)
Decreased Appetite	27 (.81%)
Dehydration	27 (.81%)
Headache	26 (.78%)
Diarrhoea	25 (.75%)
Drug Ineffective	25 (.75%)
Malaise	25 (.75%)
Somnolence	25 (.75%)
Anaemia	24 (.72%)
Blood Glucose Increased	24 (.72%)
Dizziness	23 (.69%)
Fall	23 (.69%)
Vaginal Haemorrhage	23 (.69%)
Haemoglobin Decreased	20 (.6%)
Cognitive Disorder	19 (.57%)
Meningioma	19 (.57%)
Pneumonia	19 (.57%)
Hypotension	17 (.51%)
Anorexia	16 (.48%)
Hepatic Failure	16 (.48%)
Hyponatraemia	15 (.45%)
Pyrexia	15 (.45%)
Blood Testosterone Decreased	14 (.42%)
Hot Flush	14 (.42%)
Tachycardia	14 (.42%)
Condition Aggravated	13 (.39%)
Disorientation	13 (.39%)
Failure To Thrive	13 (.39%)
Feeling Abnormal	13 (.39%)
Medication Error	13 (.39%)
Mental Status Changes	13 (.39%)
Rash	13 (.39%)
Abasia	12 (.36%)
Blood Sodium Decreased	12 (.36%)
Cerebrovascular Accident	12 (.36%)
Chest Pain	12 (.36%)
Erythema	12 (.36%)
Hyperhidrosis	12 (.36%)
Incorrect Dose Administered	12 (.36%)
Pain	12 (.36%)
Pain In Extremity	12 (.36%)
Tremor	12 (.36%)
Back Pain	11 (.33%)
Balance Disorder	11 (.33%)
Blood Cortisol Decreased	11 (.33%)
Blood Urea Increased	11 (.33%)
Oedema	11 (.33%)
Dry Mouth	10 (.3%)
Hallucination	10 (.3%)
Infection	10 (.3%)
Renal Failure	10 (.3%)
Thrombocytopenia	10 (.3%)
Blood Chloride Decreased	9 (.27%)
Blood Potassium Decreased	9 (.27%)
Blood Pressure Increased	9 (.27%)
Cardiac Failure Congestive	9 (.27%)
Depressed Level Of Consciousness	9 (.27%)
Electrolyte Imbalance	9 (.27%)
Feeling Cold	9 (.27%)
Heart Rate Increased	9 (.27%)
Hepatic Cirrhosis	9 (.27%)
Hypogonadism	9 (.27%)
Lung Neoplasm Malignant	9 (.27%)
Metastases To Central Nervous Syste...	9 (.27%)
Neutropenia	9 (.27%)
Renal Impairment	9 (.27%)
Abdominal Distension	8 (.24%)
Cachexia	8 (.24%)
Hypomagnesaemia	8 (.24%)
International Normalised Ratio Incr...	8 (.24%)
Myocardial Infarction	8 (.24%)
Neoplasm Malignant	8 (.24%)
Paraesthesia	8 (.24%)
Product Taste Abnormal	8 (.24%)
Prothrombin Time Prolonged	8 (.24%)
Pruritus	8 (.24%)
Venous Thrombosis	8 (.24%)
White Blood Cell Count Increased	8 (.24%)
Abnormal Behaviour	7 (.21%)
Androgen Deficiency	7 (.21%)
Arthralgia	7 (.21%)
Asthma	7 (.21%)
Cardiac Murmur	7 (.21%)
Drug Interaction	7 (.21%)
Haemorrhage	7 (.21%)
Hyperkalaemia	7 (.21%)

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

What are the most common Megestrol Acetate adverse events reported to the FDA?

Fatal Outcomes	269 (8.04%)
Embolism And Thrombosis	200 (5.98%)
Neurological	143 (4.28%)
Gastrointestinal Signs	139 (4.16%)
Miscellaneous And Site Unspecified ...	94 (2.81%)
Hematology Investigations	92 (2.75%)
Respiratory	78 (2.33%)
Physical Examination Topics	76 (2.27%)
Appetite And General Nutritional	74 (2.21%)
Infections - Pathogen Unspecified	74 (2.21%)
Pulmonary Vascular	69 (2.06%)
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Electrolyte And Fluid Balance Condi...	67 (2%)
Epidermal And Dermal Conditions	57 (1.7%)
Adrenal Gland	54 (1.61%)
Deliria	51 (1.53%)
Therapeutic And Nontherapeutic Effe...	50 (1.5%)
Hepatic And Hepatobiliary	45 (1.35%)
Medication Errors	41 (1.23%)
Musculoskeletal And Connective Tiss...	40 (1.2%)
Renal Disorders	38 (1.14%)
Endocrine Investigations	37 (1.11%)
Gastrointestinal Motility And Defec...	36 (1.08%)
Mental Impairment	36 (1.08%)
Lower Respiratory Tract Disorders	34 (1.02%)
Water, Electrolyte And Mineral	34 (1.02%)
Cardiac Arrhythmias	33 (.99%)
Urinary Tract Signs	33 (.99%)
Injuries	31 (.93%)
Cardiac And Vascular Investigations	30 (.9%)
Central Nervous System Vascular	29 (.87%)
Metabolic, Nutritional And Blood Ga...	29 (.87%)
Anemias Nonhemolytic And Marrow Dep...	27 (.81%)
Renal And Urinary Tract Investigati...	27 (.81%)
Skin Appendage Conditions	27 (.81%)
Headaches	26 (.78%)
Vulvovaginal Disorders	25 (.75%)
Vascular	23 (.69%)
Decreased And Nonspecific Blood Pre...	21 (.63%)
Psychiatric	21 (.63%)
Respiratory And Mediastinal Neoplas...	21 (.63%)
Joint	20 (.6%)
Nervous System Neoplasms Malignant ...	19 (.57%)
Hepatobiliary	18 (.54%)
Bone And Joint Injuries	17 (.51%)
Coronary Artery	16 (.48%)
Endocrine Disorders Of Gonadal Func...	16 (.48%)
Heart Failures	16 (.48%)
Mood Disorders	16 (.48%)
Body Temperature Conditions	15 (.45%)
Bone, Calcium, Magnesium And Phosph...	15 (.45%)
Gastrointestinal Hemorrhages	15 (.45%)
Glucose Metabolism Disorders	15 (.45%)
Metastases	15 (.45%)
Movement Disorders	15 (.45%)
Bronchial Disorders	14 (.42%)
Product Quality Issues	14 (.42%)
Disturbances In Thinking	13 (.39%)
White Blood Cell	13 (.39%)
Muscle	12 (.36%)
Anxiety Disorders	11 (.33%)
Bacterial Infectious	11 (.33%)
Depressed Mood Disorders	11 (.33%)
Salivary Gland Conditions	11 (.33%)
Fungal Infectious	10 (.3%)
Personality Disorders	10 (.3%)
Platelet	10 (.3%)
Vision	10 (.3%)
Gastrointestinal Neoplasms Malignan...	9 (.27%)
Menstrual Cycle And Uterine Bleedin...	9 (.27%)
Pleural	9 (.27%)
Bone Disorders	8 (.24%)
Gastrointestinal Inflammatory Condi...	8 (.24%)
Gastrointestinal Vascular Condition...	8 (.24%)
Vascular Hemorrhagic	8 (.24%)
Vascular Hypertensive	8 (.24%)
Gastrointestinal Conditions	7 (.21%)
Lifestyle Issues	7 (.21%)
Peritoneal And Retroperitoneal Cond...	7 (.21%)
Protein And Chemistry Analyses	7 (.21%)
Psychiatric And Behavioural Symptom...	7 (.21%)
Allergic Conditions	6 (.18%)
Breast Neoplasms Malignant And Unsp...	6 (.18%)
Cardiac Disorder Signs	6 (.18%)
Eating Disorders	6 (.18%)
Hearing	6 (.18%)
Menopause And Related Conditions	6 (.18%)
Myocardial	6 (.18%)
Renal And Urinary Tract Neoplasms M...	6 (.18%)
Sexual Function And Fertility	6 (.18%)
Sleep Disorders	6 (.18%)
Chemical Injury And Poisoning	5 (.15%)
Oral Soft Tissue Conditions	5 (.15%)
Protein And Amino Acid Metabolism	5 (.15%)
Reproductive Neoplasms Female Benig...	5 (.15%)
Seizures	5 (.15%)
Therapeutic Procedures And Supporti...	5 (.15%)
Upper Respiratory Tract Disorders	5 (.15%)
Angiedema And Urticaria	4 (.12%)
Breast	4 (.12%)
Enzyme	4 (.12%)
Procedural And Device Related Injur...	4 (.12%)

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