DICLOFENAC SODIUM

Diclofenac Sodium Adverse Events Reported to the FDA Over Time

How are Diclofenac Sodium adverse event reports trending over time?

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

Most Common Diclofenac Sodium Adverse Events Reported to the FDA

What are the most common Diclofenac Sodium adverse events reported to the FDA?

Renal Failure Acute	1019 (1.48%)
Vomiting	763 (1.11%)
Pyrexia	665 (.96%)
Diarrhoea	641 (.93%)
Nausea	641 (.93%)
Dyspnoea	622 (.9%)
Blood Creatinine Increased	561 (.81%)
Haemoglobin Decreased	545 (.79%)
Abdominal Pain	528 (.77%)
Drug Interaction	515 (.75%)
Malaise	504 (.73%)
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Alanine Aminotransferase Increased	417 (.6%)
Pain	416 (.6%)
Loss Of Consciousness	411 (.6%)
Hypotension	410 (.59%)
Anaemia	403 (.58%)
Blood Urea Increased	403 (.58%)
Aspartate Aminotransferase Increase...	399 (.58%)
Gastrointestinal Haemorrhage	394 (.57%)
C-reactive Protein Increased	389 (.56%)
Rash	384 (.56%)
Dehydration	378 (.55%)
Renal Failure	369 (.53%)
Dizziness	368 (.53%)
Abdominal Pain Upper	367 (.53%)
Erythema	363 (.53%)
Melaena	351 (.51%)
Oedema Peripheral	345 (.5%)
Haematemesis	340 (.49%)
Gastric Ulcer	338 (.49%)
Off Label Use	328 (.48%)
Fall	325 (.47%)
Pruritus	320 (.46%)
Blood Pressure Decreased	317 (.46%)
Asthenia	316 (.46%)
Drug Ineffective	312 (.45%)
Shock	301 (.44%)
Drug Administered At Inappropriate ...	296 (.43%)
Weight Decreased	279 (.4%)
Headache	268 (.39%)
Fatigue	264 (.38%)
Condition Aggravated	260 (.38%)
Gamma-glutamyltransferase Increased	257 (.37%)
Blood Alkaline Phosphatase Increase...	256 (.37%)
Blood Lactate Dehydrogenase Increas...	240 (.35%)
White Blood Cell Count Increased	239 (.35%)
Metabolic Acidosis	235 (.34%)
Chest Pain	231 (.33%)
Back Pain	230 (.33%)
Convulsion	230 (.33%)
Somnolence	227 (.33%)
Confusional State	221 (.32%)
Wrong Technique In Drug Usage Proce...	221 (.32%)
Arthralgia	220 (.32%)
Multi-organ Failure	220 (.32%)
Liver Disorder	218 (.32%)
Renal Impairment	213 (.31%)
Blood Creatine Phosphokinase Increa...	212 (.31%)
Hyperkalaemia	208 (.3%)
Platelet Count Decreased	206 (.3%)
Sepsis	204 (.3%)
Pain In Extremity	201 (.29%)
Blood Bilirubin Increased	199 (.29%)
Hypertension	199 (.29%)
Overdose	195 (.28%)
Drug Exposure During Pregnancy	192 (.28%)
Urticaria	191 (.28%)
General Physical Health Deteriorati...	190 (.28%)
Suicide Attempt	185 (.27%)
Feeling Abnormal	184 (.27%)
Rhabdomyolysis	184 (.27%)
Cardiac Arrest	179 (.26%)
Disseminated Intravascular Coagulat...	179 (.26%)
Hepatic Function Abnormal	176 (.26%)
Syncope	173 (.25%)
Tachycardia	173 (.25%)
Toxic Epidermal Necrolysis	173 (.25%)
Duodenal Ulcer	172 (.25%)
Abdominal Discomfort	171 (.25%)
Hypersensitivity	171 (.25%)
Inflammation	170 (.25%)
Depressed Level Of Consciousness	169 (.24%)
Gait Disturbance	169 (.24%)
Rectal Haemorrhage	169 (.24%)
Gastritis	167 (.24%)
Myocardial Infarction	167 (.24%)
Haemorrhage	166 (.24%)
Lactic Acidosis	165 (.24%)
Blister	163 (.24%)
Constipation	163 (.24%)
Decreased Appetite	163 (.24%)
Pneumonia	163 (.24%)
Blood Pressure Increased	153 (.22%)
Therapeutic Response Unexpected	153 (.22%)
Heart Rate Increased	151 (.22%)
Jaundice	149 (.22%)
Gastrointestinal Disorder	145 (.21%)
Paraesthesia	145 (.21%)
Haematocrit Decreased	144 (.21%)
Hypoaesthesia	144 (.21%)
International Normalised Ratio Incr...	144 (.21%)

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

What are the most common Diclofenac Sodium adverse events reported to the FDA?

Epidermal And Dermal Conditions	3368 (4.88%)
Gastrointestinal Signs	3146 (4.56%)
Neurological	2598 (3.77%)
Hematology Investigations	2312 (3.35%)
Renal Disorders	2203 (3.19%)
Respiratory	1779 (2.58%)
Gastrointestinal Ulceration And Per...	1681 (2.44%)
Gastrointestinal Hemorrhages	1664 (2.41%)
Hepatobiliary	1535 (2.22%)
Infections - Pathogen Unspecified	1504 (2.18%)
Hepatic And Hepatobiliary	1490 (2.16%)
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Medication Errors	1427 (2.07%)
Renal And Urinary Tract Investigati...	1381 (2%)
Therapeutic And Nontherapeutic Effe...	1175 (1.7%)
Cardiac And Vascular Investigations	1131 (1.64%)
Cardiac Arrhythmias	1026 (1.49%)
Gastrointestinal Motility And Defec...	1009 (1.46%)
Decreased And Nonspecific Blood Pre...	954 (1.38%)
Electrolyte And Fluid Balance Condi...	884 (1.28%)
Injuries	815 (1.18%)
Anemias Nonhemolytic And Marrow Dep...	800 (1.16%)
Enzyme	785 (1.14%)
Body Temperature Conditions	760 (1.1%)
Gastrointestinal Inflammatory Condi...	760 (1.1%)
Musculoskeletal And Connective Tiss...	725 (1.05%)
Administration Site Reactions	707 (1.02%)
Muscle	685 (.99%)
Therapeutic Procedures And Supporti...	667 (.97%)
Joint	657 (.95%)
Protein And Chemistry Analyses	605 (.88%)
Physical Examination Topics	579 (.84%)
Allergic Conditions	570 (.83%)
Metabolic, Nutritional And Blood Ga...	564 (.82%)
Water, Electrolyte And Mineral	552 (.8%)
Urinary Tract Signs	532 (.77%)
Lower Respiratory Tract Disorders	517 (.75%)
Bacterial Infectious	507 (.73%)
Acid-base	468 (.68%)
Chemical Injury And Poisoning	458 (.66%)
Coronary Artery	435 (.63%)
White Blood Cell	432 (.63%)
Oral Soft Tissue Conditions	400 (.58%)
Movement Disorders	399 (.58%)
Vision	391 (.57%)
Appetite And General Nutritional	360 (.52%)
Deliria	359 (.52%)
Gastrointestinal Stenosis And Obstr...	350 (.51%)
Headaches	324 (.47%)
Gastrointestinal Conditions	320 (.46%)
Nephropathies	320 (.46%)
Peritoneal And Retroperitoneal Cond...	314 (.46%)
Seizures	313 (.45%)
Central Nervous System Vascular	312 (.45%)
Coagulopathies And Bleeding Diathes...	310 (.45%)
Procedural And Device Related Injur...	308 (.45%)
Skin Vascular Abnormalities	297 (.43%)
Suicidal And Self-injurious Behavio...	297 (.43%)
Ocular Infections, Irritations And ...	295 (.43%)
Angiedema And Urticaria	289 (.42%)
Vascular	275 (.4%)
Heart Failures	263 (.38%)
Upper Respiratory Tract Disorders	258 (.37%)
Hematological And Lymphoid Tissue T...	257 (.37%)
Viral Infectious	256 (.37%)
Vascular Hemorrhagic	243 (.35%)
Skin Appendage Conditions	231 (.33%)
Tissue	228 (.33%)
Vascular Hypertensive	225 (.33%)
Bronchial Disorders	219 (.32%)
Anxiety Disorders	217 (.31%)
Gastrointestinal Therapeutic Proced...	209 (.3%)
Cardiac Disorder Signs	196 (.28%)
Mental Impairment	196 (.28%)
Eye	192 (.28%)
Lifestyle Issues	188 (.27%)
Bone And Joint Injuries	181 (.26%)
Gastrointestinal	179 (.26%)
Psychiatric	176 (.26%)
Pleural	175 (.25%)
Glucose Metabolism Disorders	173 (.25%)
Immunology And Allergy	172 (.25%)
Platelet	160 (.23%)
Sleep Disorders	159 (.23%)
Bone Disorders	155 (.22%)
Myocardial	155 (.22%)
Fatal Outcomes	151 (.22%)
Tongue Conditions	134 (.19%)
Embolism And Thrombosis	133 (.19%)
Arteriosclerosis, Stenosis, Vascula...	132 (.19%)
Disturbances In Thinking	130 (.19%)
Encephalopathies	128 (.19%)
Bone And Joint Therapeutic Procedur...	125 (.18%)
Depressed Mood Disorders	124 (.18%)
Pulmonary Vascular	121 (.18%)
Ocular Neuromuscular	119 (.17%)
Investigations, Imaging And Histopa...	115 (.17%)
Neurological, Special Senses And Ps...	115 (.17%)
Microbiology And Serology	110 (.16%)
Skin And Subcutaneous Tissue	110 (.16%)
Spleen, Lymphatic And Reticulendoth...	106 (.15%)
Musculoskeletal And Connective Tiss...	101 (.15%)

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