EGRIFTA

Egrifta Adverse Events Reported to the FDA Over Time

How are Egrifta adverse event reports trending over time?

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

Most Common Egrifta Adverse Events Reported to the FDA

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

Injection Site Pain	38 (2.98%)
Arthralgia	33 (2.58%)
Injection Site Haematoma	32 (2.51%)
Blood Glucose Increased	26 (2.04%)
Nausea	26 (2.04%)
Fatigue	25 (1.96%)
Oedema Peripheral	25 (1.96%)
Dizziness	24 (1.88%)
Headache	23 (1.8%)
Weight Increased	23 (1.8%)
Myalgia	20 (1.57%)
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Diarrhoea	19 (1.49%)
Pain In Extremity	19 (1.49%)
Blood Pressure Increased	17 (1.33%)
Abdominal Distension	16 (1.25%)
Pain	15 (1.17%)
Paraesthesia	15 (1.17%)
Diabetes Mellitus	14 (1.1%)
Injection Site Pruritus	13 (1.02%)
Myocardial Infarction	13 (1.02%)
Vomiting	13 (1.02%)
Weight Decreased	13 (1.02%)
Carpal Tunnel Syndrome	12 (.94%)
Insomnia	11 (.86%)
Palpitations	11 (.86%)
Asthenia	10 (.78%)
Hypoaesthesia	10 (.78%)
Injection Site Erythema	10 (.78%)
Injection Site Haemorrhage	10 (.78%)
Vision Blurred	10 (.78%)
Anxiety	9 (.7%)
Breast Cancer	9 (.7%)
Depression	9 (.7%)
Hyperhidrosis	9 (.7%)
Malaise	9 (.7%)
Renal Failure	9 (.7%)
Swelling	9 (.7%)
Glycosylated Haemoglobin Increased	8 (.63%)
Joint Swelling	8 (.63%)
Abdominal Pain	7 (.55%)
Abdominal Pain Upper	7 (.55%)
Gynaecomastia	7 (.55%)
Hot Flush	7 (.55%)
Hypersomnia	7 (.55%)
Injection Site Swelling	7 (.55%)
Neuropathy Peripheral	7 (.55%)
Feeling Abnormal	6 (.47%)
Injection Site Rash	6 (.47%)
Muscle Spasms	6 (.47%)
Anogenital Dysplasia	5 (.39%)
Blood Cholesterol Increased	5 (.39%)
Dyspepsia	5 (.39%)
Dysuria	5 (.39%)
Heart Rate Increased	5 (.39%)
Hypersensitivity	5 (.39%)
Hypertension	5 (.39%)
Musculoskeletal Pain	5 (.39%)
Nasopharyngitis	5 (.39%)
Pruritus	5 (.39%)
Pulmonary Oedema	5 (.39%)
Pyrexia	5 (.39%)
Rash	5 (.39%)
Sinusitis	5 (.39%)
Suicidal Behaviour	5 (.39%)
Tremor	5 (.39%)
Unevaluable Event	5 (.39%)
Back Pain	4 (.31%)
Blood Creatine Phosphokinase Increa...	4 (.31%)
Blood Glucose Abnormal	4 (.31%)
Bone Pain	4 (.31%)
Chest Pain	4 (.31%)
Chills	4 (.31%)
Constipation	4 (.31%)
Contusion	4 (.31%)
Death	4 (.31%)
Dyspnoea	4 (.31%)
Fall	4 (.31%)
Hypotension	4 (.31%)
Incorrect Dose Administered	4 (.31%)
Injection Site Vesicles	4 (.31%)
Migraine	4 (.31%)
No Adverse Event	4 (.31%)
Pneumonia	4 (.31%)
Pollakiuria	4 (.31%)
Road Traffic Accident	4 (.31%)
Swelling Face	4 (.31%)
T-lymphocyte Count Increased	4 (.31%)
Type 2 Diabetes Mellitus	4 (.31%)
Urticaria	4 (.31%)
Abdominal Tenderness	3 (.23%)
Arthritis	3 (.23%)
Basal Cell Carcinoma	3 (.23%)
Burning Sensation	3 (.23%)
Cachexia	3 (.23%)
Cardiac Disorder	3 (.23%)
Colorectal Cancer Stage Iv	3 (.23%)
Condition Aggravated	3 (.23%)
Coronary Artery Occlusion	3 (.23%)
Cough	3 (.23%)
Decreased Appetite	3 (.23%)
Diverticulitis	3 (.23%)

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

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

Administration Site Reactions	137 (10.73%)
Gastrointestinal Signs	87 (6.81%)
Neurological	67 (5.25%)
Joint	48 (3.76%)
Metabolic, Nutritional And Blood Ga...	42 (3.29%)
Physical Examination Topics	40 (3.13%)
Infections - Pathogen Unspecified	37 (2.9%)
Musculoskeletal And Connective Tiss...	37 (2.9%)
Muscle	33 (2.58%)
Gastrointestinal Motility And Defec...	28 (2.19%)
Headaches	27 (2.11%)
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Epidermal And Dermal Conditions	24 (1.88%)
Glucose Metabolism Disorders	23 (1.8%)
Cardiac And Vascular Investigations	22 (1.72%)
Peripheral Neuropathies	19 (1.49%)
Injuries	18 (1.41%)
Respiratory	17 (1.33%)
Skin Appendage Conditions	17 (1.33%)
Coronary Artery	16 (1.25%)
Renal Disorders	15 (1.17%)
Cardiac Disorder Signs	14 (1.1%)
Sleep Disorders	14 (1.1%)
Medication Errors	13 (1.02%)
Anxiety Disorders	12 (.94%)
Urinary Tract Signs	12 (.94%)
Depressed Mood Disorders	11 (.86%)
Hematology Investigations	11 (.86%)
Vision	11 (.86%)
Breast	9 (.7%)
Breast Neoplasms Malignant And Unsp...	9 (.7%)
Gastrointestinal Neoplasms Malignan...	9 (.7%)
Vascular	9 (.7%)
Appetite And General Nutritional	8 (.63%)
Lipid Analyses	8 (.63%)
Lower Respiratory Tract Disorders	8 (.63%)
Upper Respiratory Tract Disorders	8 (.63%)
Viral Infectious	8 (.63%)
Allergic Conditions	7 (.55%)
Movement Disorders	7 (.55%)
Sleep Disturbances	7 (.55%)
Miscellaneous And Site Unspecified ...	6 (.47%)
Suicidal And Self-injurious Behavio...	6 (.47%)
Therapeutic And Nontherapeutic Effe...	6 (.47%)
Anal And Rectal Conditions	5 (.39%)
Body Temperature Conditions	5 (.39%)
Bone And Joint Therapeutic Procedur...	5 (.39%)
Bone Disorders	5 (.39%)
Decreased And Nonspecific Blood Pre...	5 (.39%)
Enzyme	5 (.39%)
Mood Disorders	5 (.39%)
Tendon, Ligament And Cartilage	5 (.39%)
Vascular Hypertensive	5 (.39%)
Anemias Nonhemolytic And Marrow Dep...	4 (.31%)
Angiedema And Urticaria	4 (.31%)
Cardiac Arrhythmias	4 (.31%)
Electrolyte And Fluid Balance Condi...	4 (.31%)
Embolism And Thrombosis	4 (.31%)
Endocrine Investigations	4 (.31%)
Fatal Outcomes	4 (.31%)
Hepatic And Hepatobiliary	4 (.31%)
Hepatobiliary	4 (.31%)
Procedural And Device Related Injur...	4 (.31%)
Tissue	4 (.31%)
Bacterial Infectious	3 (.23%)
Cardiac And Vascular Disorders Cong...	3 (.23%)
Exocrine Pancreas Conditions	3 (.23%)
Gastrointestinal Hemorrhages	3 (.23%)
Menstrual Cycle And Uterine Bleedin...	3 (.23%)
Nephropathies	3 (.23%)
Renal And Urinary Tract Investigati...	3 (.23%)
Skin Neoplasms Malignant And Unspec...	3 (.23%)
Bone And Joint Injuries	2 (.16%)
Cardiac Therapeutic Procedures	2 (.16%)
Disturbances In Thinking	2 (.16%)
Gastrointestinal Therapeutic Proced...	2 (.16%)
Head And Neck Therapeutic Procedure...	2 (.16%)
Hepatobiliary Therapeutic Procedure...	2 (.16%)
Lifestyle Issues	2 (.16%)
Oral Soft Tissue Conditions	2 (.16%)
Personality Disorders	2 (.16%)
Pulmonary Vascular	2 (.16%)
Salivary Gland Conditions	2 (.16%)
Schizophrenia And Other Psychotic	2 (.16%)
Skin And Subcutaneous Tissue	2 (.16%)
Soft Tissue Therapeutic Procedures	2 (.16%)
Water, Electrolyte And Mineral	2 (.16%)
Abdominal Hernias And Other Abdomin...	1 (.08%)
Age Related Factors	1 (.08%)
Arteriosclerosis, Stenosis, Vascula...	1 (.08%)
Bronchial Disorders	1 (.08%)
Connective Tissue Disorders	1 (.08%)
Cornification And Dystrophic Skin	1 (.08%)
Cutaneous Neoplasms Benign	1 (.08%)
Deliria	1 (.08%)
Dental And Gingival Conditions	1 (.08%)
Heart Failures	1 (.08%)
Hematological	1 (.08%)
Inner Ear And Viiith Cranial Nerve	1 (.08%)
Investigations, Imaging And Histopa...	1 (.08%)
Mental Impairment	1 (.08%)
Microbiology And Serology	1 (.08%)

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