COLCRYS

Colcrys Adverse Events Reported to the FDA Over Time

How are Colcrys adverse event reports trending over time?

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

Most Common Colcrys Adverse Events Reported to the FDA

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

Diarrhoea	139 (10.88%)
Drug Ineffective	100 (7.82%)
Nausea	32 (2.5%)
Dizziness	24 (1.88%)
Off Label Use	24 (1.88%)
Hypoaesthesia	23 (1.8%)
Drug Effect Decreased	22 (1.72%)
Paraesthesia	22 (1.72%)
Abdominal Pain Upper	21 (1.64%)
Product Substitution Issue	19 (1.49%)
Asthenia	18 (1.41%)
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Insomnia	18 (1.41%)
Muscular Weakness	18 (1.41%)
Rash	17 (1.33%)
Vomiting	17 (1.33%)
Myalgia	16 (1.25%)
Dyspnoea	15 (1.17%)
Fatigue	13 (1.02%)
Abdominal Pain	11 (.86%)
Dehydration	11 (.86%)
Pyrexia	11 (.86%)
Decreased Appetite	10 (.78%)
Headache	10 (.78%)
Maternal Drugs Affecting Foetus	10 (.78%)
Renal Failure Acute	10 (.78%)
Weight Decreased	10 (.78%)
Dyspepsia	9 (.7%)
Pain In Extremity	9 (.7%)
Abdominal Discomfort	8 (.63%)
Drug Interaction	8 (.63%)
Gout	8 (.63%)
Oedema Peripheral	8 (.63%)
Pain	8 (.63%)
Pollakiuria	8 (.63%)
Back Pain	7 (.55%)
Alopecia	6 (.47%)
Chills	6 (.47%)
Condition Aggravated	6 (.47%)
Familial Mediterranean Fever	6 (.47%)
Diarrhoea Haemorrhagic	5 (.39%)
Dysphagia	5 (.39%)
Dysstasia	5 (.39%)
Gastroenteritis	5 (.39%)
Haematochezia	5 (.39%)
Lip Swelling	5 (.39%)
Malaise	5 (.39%)
Musculoskeletal Stiffness	5 (.39%)
Neuropathy Peripheral	5 (.39%)
Platelet Count Decreased	5 (.39%)
Prostate Cancer	5 (.39%)
Skin Discolouration	5 (.39%)
Swelling Face	5 (.39%)
Urticaria	5 (.39%)
White Blood Cell Count Increased	5 (.39%)
Anaemia	4 (.31%)
Blood Pressure Increased	4 (.31%)
Erythema	4 (.31%)
Gait Disturbance	4 (.31%)
Hyperhidrosis	4 (.31%)
Hypotension	4 (.31%)
Joint Stiffness	4 (.31%)
Oral Discomfort	4 (.31%)
Pallor	4 (.31%)
Prostatic Specific Antigen Increase...	4 (.31%)
Rash Generalised	4 (.31%)
Renal Failure	4 (.31%)
Rhabdomyolysis	4 (.31%)
Swollen Tongue	4 (.31%)
Throat Irritation	4 (.31%)
Tongue Discolouration	4 (.31%)
Tooth Disorder	4 (.31%)
White Blood Cell Count Decreased	4 (.31%)
Agitation	3 (.23%)
Alanine Aminotransferase Increased	3 (.23%)
Anger	3 (.23%)
Arthralgia	3 (.23%)
Aspartate Aminotransferase Increase...	3 (.23%)
Blood Creatine Phosphokinase Increa...	3 (.23%)
Blood Creatinine Increased	3 (.23%)
Constipation	3 (.23%)
Convulsion	3 (.23%)
Death	3 (.23%)
Delirium	3 (.23%)
Disease Recurrence	3 (.23%)
Drug Hypersensitivity	3 (.23%)
Economic Problem	3 (.23%)
Eyelid Oedema	3 (.23%)
Gastrooesophageal Reflux Disease	3 (.23%)
Haemoglobin Decreased	3 (.23%)
Hepatic Enzyme Increased	3 (.23%)
Intraocular Pressure Increased	3 (.23%)
Lethargy	3 (.23%)
Mental Status Changes	3 (.23%)
Muscle Spasms	3 (.23%)
Overdose	3 (.23%)
Paralysis	3 (.23%)
Presyncope	3 (.23%)
Pruritus	3 (.23%)
Respiratory Failure	3 (.23%)
Restless Legs Syndrome	3 (.23%)
Suicidal Ideation	3 (.23%)

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

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

Gastrointestinal Motility And Defec...	151 (11.82%)
Therapeutic And Nontherapeutic Effe...	134 (10.49%)
Gastrointestinal Signs	111 (8.69%)
Neurological	90 (7.04%)
Epidermal And Dermal Conditions	43 (3.36%)
Muscle	43 (3.36%)
Respiratory	34 (2.66%)
Therapeutic Procedures And Supporti...	25 (1.96%)
Musculoskeletal And Connective Tiss...	24 (1.88%)
Sleep Disorders	22 (1.72%)
Hematology Investigations	21 (1.64%)
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Product Quality Issues	20 (1.56%)
Urinary Tract Signs	19 (1.49%)
Renal Disorders	16 (1.25%)
Joint	15 (1.17%)
Physical Examination Topics	15 (1.17%)
Skin Appendage Conditions	15 (1.17%)
Chemical Injury And Poisoning	14 (1.1%)
Electrolyte And Fluid Balance Condi...	13 (1.02%)
Infections - Pathogen Unspecified	13 (1.02%)
Oral Soft Tissue Conditions	13 (1.02%)
Body Temperature Conditions	11 (.86%)
Hepatobiliary	11 (.86%)
Tongue Conditions	11 (.86%)
Appetite And General Nutritional	10 (.78%)
Cardiac And Vascular Investigations	10 (.78%)
Headaches	10 (.78%)
Gastrointestinal Hemorrhages	9 (.7%)
Medication Errors	9 (.7%)
Purine And Pyrimidine Metabolism	8 (.63%)
Renal And Urinary Tract Investigati...	8 (.63%)
Upper Respiratory Tract Disorders	8 (.63%)
Cardiac Arrhythmias	7 (.55%)
Allergic Conditions	6 (.47%)
Congenital And Hereditary	6 (.47%)
Deliria	6 (.47%)
Dental And Gingival Conditions	6 (.47%)
Enzyme	6 (.47%)
Mood Disorders	6 (.47%)
Peripheral Neuropathies	6 (.47%)
Suicidal And Self-injurious Behavio...	6 (.47%)
Anemias Nonhemolytic And Marrow Dep...	5 (.39%)
Angiedema And Urticaria	5 (.39%)
Anxiety Disorders	5 (.39%)
Decreased And Nonspecific Blood Pre...	5 (.39%)
Mental Impairment	5 (.39%)
Psychiatric	5 (.39%)
Reproductive Neoplasms Male Maligna...	5 (.39%)
Seizures	5 (.39%)
Vascular	5 (.39%)
White Blood Cell	5 (.39%)
Gastrointestinal Ulceration And Per...	4 (.31%)
Hematological And Lymphoid Tissue T...	4 (.31%)
Immunology And Allergy	4 (.31%)
Lifestyle Issues	4 (.31%)
Movement Disorders	4 (.31%)
Musculoskeletal And Connective Tiss...	4 (.31%)
Ocular Infections, Irritations And ...	4 (.31%)
Cranial Nerve Disorders	3 (.23%)
Disturbances In Thinking	3 (.23%)
Economic And Housing Issues	3 (.23%)
Fatal Outcomes	3 (.23%)
Gastrointestinal Conditions	3 (.23%)
Injuries	3 (.23%)
Lower Respiratory Tract Disorders	3 (.23%)
Neurological, Special Senses And Ps...	3 (.23%)
Obstetric And Gynecological Therape...	3 (.23%)
Vision	3 (.23%)
Arteriosclerosis, Stenosis, Vascula...	2 (.16%)
Bladder And Bladder Neck Disorders	2 (.16%)
Bone, Calcium, Magnesium And Phosph...	2 (.16%)
Bronchial Disorders	2 (.16%)
Cardiac Disorder Signs	2 (.16%)
Coronary Artery	2 (.16%)
Exocrine Pancreas Conditions	2 (.16%)
Heart Failures	2 (.16%)
Increased Intracranial Pressure And...	2 (.16%)
Metabolic, Nutritional And Blood Ga...	2 (.16%)
Musculoskeletal And Soft Tissue Inv...	2 (.16%)
Neonatal And Perinatal Conditions	2 (.16%)
Nervous System Neoplasms Benign	2 (.16%)
Neurological Disorders Congenital	2 (.16%)
Salivary Gland Conditions	2 (.16%)
Schizophrenia And Other Psychotic	2 (.16%)
Tissue	2 (.16%)
Viral Infectious	2 (.16%)
Abdominal Hernias And Other Abdomin...	1 (.08%)
Acid-base	1 (.08%)
Bacterial Infectious	1 (.08%)
Bone And Joint Injuries	1 (.08%)
Bone And Joint Therapeutic Procedur...	1 (.08%)
Cardiac And Vascular Disorders Cong...	1 (.08%)
Central Nervous System Vascular	1 (.08%)
Changes In Physical Activity	1 (.08%)
Coagulopathies And Bleeding Diathes...	1 (.08%)
Diverticular	1 (.08%)
Embolism And Thrombosis	1 (.08%)
Endocrine Disorders Congenital	1 (.08%)
Eye	1 (.08%)
Fungal Infectious	1 (.08%)
Gastrointestinal Tract Disorders Co...	1 (.08%)

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