DULCOLAX

Dulcolax Adverse Events Reported to the FDA Over Time

How are Dulcolax adverse event reports trending over time?

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

Most Common Dulcolax Adverse Events Reported to the FDA

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

Diarrhoea	76 (2.53%)
Constipation	66 (2.2%)
Nausea	64 (2.13%)
Vomiting	62 (2.07%)
Abdominal Pain	46 (1.53%)
Drug Ineffective	43 (1.43%)
Asthenia	42 (1.4%)
Dizziness	39 (1.3%)
Fatigue	39 (1.3%)
Rectal Haemorrhage	31 (1.03%)
Loss Of Consciousness	29 (.97%)
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Muscle Spasms	27 (.9%)
Fall	26 (.87%)
Pyrexia	26 (.87%)
Dyspnoea	25 (.83%)
Abdominal Pain Upper	24 (.8%)
Headache	24 (.8%)
Hyponatraemia	24 (.8%)
Syncope	24 (.8%)
Chest Pain	23 (.77%)
Medication Error	23 (.77%)
Overdose	22 (.73%)
Anxiety	21 (.7%)
Dehydration	21 (.7%)
Pain	21 (.7%)
Anaemia	20 (.67%)
Hyperhidrosis	20 (.67%)
Malaise	20 (.67%)
Renal Failure Acute	20 (.67%)
Abdominal Distension	19 (.63%)
Drug Dependence	18 (.6%)
Insomnia	18 (.6%)
Injury	16 (.53%)
Hypersensitivity	15 (.5%)
Hypotension	15 (.5%)
Confusional State	14 (.47%)
Haematochezia	14 (.47%)
Haemorrhoids	14 (.47%)
Convulsion	13 (.43%)
Death	13 (.43%)
Flatulence	13 (.43%)
Drug Abuse	12 (.4%)
Feeling Abnormal	12 (.4%)
Pain In Extremity	12 (.4%)
Aspartate Aminotransferase Increase...	11 (.37%)
Chills	11 (.37%)
Febrile Neutropenia	11 (.37%)
Hip Fracture	11 (.37%)
Alanine Aminotransferase Increased	10 (.33%)
Blood Pressure Increased	10 (.33%)
Colitis Ischaemic	10 (.33%)
Colonic Polyp	10 (.33%)
Cough	10 (.33%)
Gastrointestinal Haemorrhage	10 (.33%)
Heart Rate Increased	10 (.33%)
Heart Rate Irregular	10 (.33%)
Lethargy	10 (.33%)
Myocardial Infarction	10 (.33%)
Night Sweats	10 (.33%)
Oral Disorder	10 (.33%)
Skin Laceration	10 (.33%)
Abnormal Loss Of Weight	9 (.3%)
Bronchitis	9 (.3%)
Coma	9 (.3%)
Drug Interaction	9 (.3%)
Drug Toxicity	9 (.3%)
Economic Problem	9 (.3%)
Eosinophilia	9 (.3%)
Hepatic Lesion	9 (.3%)
Oropharyngeal Pain	9 (.3%)
Pancreatic Disorder	9 (.3%)
Pilonidal Cyst	9 (.3%)
Platelet Count Decreased	9 (.3%)
Sinusitis	9 (.3%)
Somnolence	9 (.3%)
Splenic Lesion	9 (.3%)
Stem Cell Transplant	9 (.3%)
Stomatitis	9 (.3%)
Thyroiditis	9 (.3%)
Upper Respiratory Tract Infection	9 (.3%)
White Blood Cell Count Increased	9 (.3%)
Back Pain	8 (.27%)
Blood Potassium Decreased	8 (.27%)
Blood Urea Increased	8 (.27%)
Cholelithiasis	8 (.27%)
Depression	8 (.27%)
Haematoma	8 (.27%)
Hypokalaemia	8 (.27%)
Lymphadenopathy	8 (.27%)
Pancreatitis	8 (.27%)
Poisoning	8 (.27%)
Rash	8 (.27%)
Road Traffic Accident	8 (.27%)
Tremor	8 (.27%)
Unresponsive To Stimuli	8 (.27%)
Weight Decreased	8 (.27%)
Abdominal Pain Lower	7 (.23%)
Accidental Exposure	7 (.23%)
Cardiac Disorder	7 (.23%)
Catheter Placement	7 (.23%)
Catheter Removal	7 (.23%)

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

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

Gastrointestinal Signs	293 (9.76%)
Neurological	173 (5.76%)
Gastrointestinal Motility And Defec...	172 (5.73%)
Medication Errors	99 (3.3%)
Injuries	95 (3.16%)
Respiratory	77 (2.56%)
Infections - Pathogen Unspecified	74 (2.47%)
Electrolyte And Fluid Balance Condi...	64 (2.13%)
Therapeutic And Nontherapeutic Effe...	63 (2.1%)
Gastrointestinal Hemorrhages	60 (2%)
Epidermal And Dermal Conditions	57 (1.9%)
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Hematology Investigations	52 (1.73%)
Hepatic And Hepatobiliary	44 (1.47%)
Cardiac And Vascular Investigations	43 (1.43%)
Muscle	43 (1.43%)
Psychiatric	43 (1.43%)
Renal Disorders	43 (1.43%)
Skin Appendage Conditions	39 (1.3%)
Musculoskeletal And Connective Tiss...	35 (1.17%)
Anemias Nonhemolytic And Marrow Dep...	32 (1.07%)
Hepatobiliary	32 (1.07%)
Oral Soft Tissue Conditions	32 (1.07%)
Bone And Joint Injuries	30 (1%)
Anxiety Disorders	29 (.97%)
Headaches	28 (.93%)
Body Temperature Conditions	26 (.87%)
Cardiac Arrhythmias	26 (.87%)
Therapeutic Procedures And Supporti...	26 (.87%)
White Blood Cell	26 (.87%)
Gastrointestinal Inflammatory Condi...	25 (.83%)
Chemical Injury And Poisoning	24 (.8%)
Central Nervous System Vascular	23 (.77%)
Spleen, Lymphatic And Reticulendoth...	23 (.77%)
Gallbladder	22 (.73%)
Decreased And Nonspecific Blood Pre...	21 (.7%)
Gastrointestinal Vascular Condition...	21 (.7%)
Water, Electrolyte And Mineral	21 (.7%)
Allergic Conditions	19 (.63%)
Deliria	19 (.63%)
Renal And Urinary Tract Investigati...	19 (.63%)
Exocrine Pancreas Conditions	18 (.6%)
Hematological And Lymphoid Tissue T...	18 (.6%)
Metabolic, Nutritional And Blood Ga...	18 (.6%)
Physical Examination Topics	18 (.6%)
Sleep Disorders	18 (.6%)
Coronary Artery	17 (.57%)
Appetite And General Nutritional	16 (.53%)
Lifestyle Issues	16 (.53%)
Thyroid Gland	15 (.5%)
Fatal Outcomes	14 (.47%)
Gastrointestinal Conditions	14 (.47%)
Seizures	14 (.47%)
Bacterial Infectious	13 (.43%)
Cardiac Disorder Signs	13 (.43%)
Joint	13 (.43%)
Mood Disorders	13 (.43%)
Movement Disorders	13 (.43%)
Tissue	13 (.43%)
Benign Neoplasms Gastrointestinal	12 (.4%)
Vascular	12 (.4%)
Anal And Rectal Conditions	11 (.37%)
Mental Impairment	11 (.37%)
Procedural And Device Related Injur...	11 (.37%)
Upper Respiratory Tract Disorders	11 (.37%)
Bone And Joint Therapeutic Procedur...	9 (.3%)
Economic And Housing Issues	9 (.3%)
Gastrointestinal Ulceration And Per...	9 (.3%)
Lower Respiratory Tract Disorders	9 (.3%)
Tongue Conditions	9 (.3%)
Vascular Hemorrhagic	9 (.3%)
Depressed Mood Disorders	8 (.27%)
Gastrointestinal Stenosis And Obstr...	8 (.27%)
Urinary Tract Signs	8 (.27%)
Angiedema And Urticaria	7 (.23%)
Bronchial Disorders	7 (.23%)
Embolism And Thrombosis	7 (.23%)
Product Quality Issues	7 (.23%)
Vascular Hypertensive	7 (.23%)
Bone, Calcium, Magnesium And Phosph...	6 (.2%)
Head And Neck Therapeutic Procedure...	6 (.2%)
Abdominal Hernias And Other Abdomin...	5 (.17%)
Bladder And Bladder Neck Disorders	5 (.17%)
Cutaneous Neoplasms Benign	5 (.17%)
Diverticular	5 (.17%)
Maternal Complications Of Labour An...	5 (.17%)
Musculoskeletal And Connective Tiss...	5 (.17%)
Respiratory And Mediastinal Neoplas...	5 (.17%)
Salivary Gland Conditions	5 (.17%)
Viral Infectious	5 (.17%)
Vision	5 (.17%)
Vulvovaginal Disorders	5 (.17%)
Cranial Nerve Disorders	4 (.13%)
Dental And Gingival Conditions	4 (.13%)
Disturbances In Thinking	4 (.13%)
Endocrine Neoplasms Malignant And U...	4 (.13%)
Enzyme	4 (.13%)
Gastrointestinal	4 (.13%)
Glucose Metabolism Disorders	4 (.13%)
Investigations, Imaging And Histopa...	4 (.13%)
Ocular Infections, Irritations And ...	4 (.13%)
Ocular Neuromuscular	4 (.13%)

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