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Diclofenac Adverse Events Reported to the FDA Over Time

How are Diclofenac adverse event reports trending over time?

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

Most Common Diclofenac Adverse Events Reported to the FDA

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

Drug Ineffective
657 (1.67%)
Renal Failure Acute
635 (1.61%)
Diarrhoea
504 (1.28%)
Nausea
487 (1.23%)
Vomiting
484 (1.23%)
Abdominal Pain
366 (.93%)
Malaise
319 (.81%)
Drug Interaction
315 (.8%)
Pain
313 (.79%)
Dyspnoea
309 (.78%)
Dizziness
308 (.78%)
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Gastrointestinal Haemorrhage
277 (.7%)
Blood Creatinine Increased
263 (.67%)
Haemoglobin Decreased
257 (.65%)
Abdominal Pain Upper
252 (.64%)
Dehydration
252 (.64%)
Hypotension
243 (.62%)
Pyrexia
231 (.59%)
Rash
231 (.59%)
Renal Failure
224 (.57%)
Pruritus
223 (.57%)
Haematemesis
221 (.56%)
Headache
219 (.56%)
Oedema Peripheral
207 (.52%)
Fall
203 (.51%)
Metabolic Acidosis
202 (.51%)
Anaemia
197 (.5%)
Abdominal Discomfort
190 (.48%)
Fatigue
190 (.48%)
Loss Of Consciousness
185 (.47%)
Melaena
185 (.47%)
Blood Urea Increased
180 (.46%)
Somnolence
179 (.45%)
Chest Pain
176 (.45%)
Erythema
176 (.45%)
Weight Decreased
175 (.44%)
Asthenia
170 (.43%)
Alanine Aminotransferase Increased
164 (.42%)
Condition Aggravated
162 (.41%)
Arthralgia
152 (.39%)
Gastric Ulcer
150 (.38%)
Confusional State
147 (.37%)
Convulsion
147 (.37%)
Pain In Extremity
147 (.37%)
Feeling Abnormal
146 (.37%)
Back Pain
139 (.35%)
Lactic Acidosis
139 (.35%)
Multi-organ Failure
138 (.35%)
Aspartate Aminotransferase Increase...
128 (.32%)
Gastrointestinal Disorder
128 (.32%)
Hypertension
127 (.32%)
Cardiac Arrest
126 (.32%)
Hyperkalaemia
122 (.31%)
Myocardial Infarction
121 (.31%)
Suicide Attempt
116 (.29%)
Tachycardia
116 (.29%)
Blood Alkaline Phosphatase Increase...
115 (.29%)
Gastritis
111 (.28%)
Urticaria
111 (.28%)
Duodenal Ulcer
109 (.28%)
International Normalised Ratio Incr...
109 (.28%)
Drug Toxicity
108 (.27%)
C-reactive Protein Increased
106 (.27%)
Hypersensitivity
106 (.27%)
Blood Pressure Increased
105 (.27%)
Renal Impairment
105 (.27%)
Sepsis
105 (.27%)
Application Site Rash
104 (.26%)
Blood Pressure Decreased
103 (.26%)
Drug Exposure During Pregnancy
102 (.26%)
General Physical Health Deteriorati...
101 (.26%)
Rectal Haemorrhage
101 (.26%)
Myalgia
98 (.25%)
Syncope
97 (.25%)
Application Site Pain
96 (.24%)
Bradycardia
96 (.24%)
Gait Disturbance
96 (.24%)
Rhabdomyolysis
96 (.24%)
Heart Rate Increased
95 (.24%)
Decreased Appetite
93 (.24%)
Overdose
93 (.24%)
Blood Bilirubin Increased
92 (.23%)
Intentional Overdose
92 (.23%)
Anaphylactic Reaction
91 (.23%)
Constipation
91 (.23%)
Shock
90 (.23%)
Peritonitis
88 (.22%)
Pneumonia
88 (.22%)
Colitis
86 (.22%)
Hyperhidrosis
86 (.22%)
Oedema
84 (.21%)
Abdominal Distension
83 (.21%)
Chills
83 (.21%)
Paraesthesia
83 (.21%)
Circulatory Collapse
82 (.21%)
Application Site Erythema
81 (.21%)
Disorientation
81 (.21%)
Haemodialysis
81 (.21%)
Swelling Face
81 (.21%)
Blood Creatine Phosphokinase Increa...
80 (.2%)
Haematochezia
80 (.2%)

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

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

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

Common Uses of Diclofenac According to Those Reporting Adverse Events

Why are people taking Diclofenac, according to those reporting adverse events to the FDA?

Pain
1584
Drug Use For Unknown Indication
1526
Rheumatoid Arthritis
1463
Back Pain
1017
Product Used For Unknown Indication
965
Arthritis
819
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Arthralgia
784
Osteoarthritis
579
Pain In Extremity
234
Musculoskeletal Pain
184
Inflammation
160
Analgesic Therapy
148
Neck Pain
133
Ankylosing Spondylitis
123
Ill-defined Disorder
111
Antiinflammatory Therapy
101
Gout
96
Analgesia
92
Sciatica
84
Pyrexia
83
Psoriatic Arthropathy
79
Tendonitis
75
Bone Pain
72
Cancer Pain
70
Abdominal Pain
67
Myalgia
65
Procedural Pain
64
Intervertebral Disc Protrusion
64
Migraine
63
Headache
60
Spinal Osteoarthritis
58
Bursitis
49
Arthropathy
48
Postoperative Analgesia
45
Neuralgia
44
Muscle Strain
40
Analgesic Effect
39
Muscle Spasms
39
Juvenile Arthritis
38
Fibromyalgia
34
Postoperative Care
32
Osteoporosis
29
Pain Management
26
Suicide Attempt
26
Joint Injury
25
Dysmenorrhoea
24
Toothache
22
Nasopharyngitis
21
Swelling
21
Urinary Tract Infection
21
Back Disorder
21

Drug Labels

LabelLabelerEffective
Diclofenac SodiumActavis Elizabeth LLC01-MAR-09
Diclofenac Sodium Extended-releaseRebel Distributors Corp.01-JUN-09
ZipsorPD-Rx Pharmaceuticals, Inc.05-JUN-09
Diclofenac Sodium Stat Rx USA27-OCT-09
Diclofenac PotassiumStat Rx USA27-OCT-09
ArthrotecRebel Distributors Corp.10-NOV-09
Diclofenac SodiumPreferred Pharmaceuticals, Inc17-DEC-09
Diclofenac SodiumMylan Pharmaceuticals Inc.17-DEC-09
Diclofenac SodiumMylan Pharmaceuticals Inc.21-JAN-10
Diclofenac Sodium PD-Rx Pharmaceuticals, Inc.21-JAN-10
Diclofenac PotassiumPhysicians Total Care, Inc.21-JAN-10
Diclofenac PotassiumBryant Ranch Prepack21-JAN-10
Diclofenac SodiumSandoz Inc02-MAY-10
Diclofenac SodiumUDL Laboratories, Inc.04-JUN-10
PennsaidMallinckrodt Inc.09-JUN-10
PennsaidUnit Dose Services09-JUN-10
Diclofenac SodiumKeltman Pharmaceuticals Inc.11-JUN-10
Diclofenac PotassiumRebel Distributors Corp24-SEP-10
Diclofenac SodiumRebel Distributors Corp24-SEP-10
FlectorRebel Distributors Corp27-SEP-10
PennsaidSTAT RX USA LLC01-OCT-10
Zipsor Lake Erie Medical DBA Quality Care Products22-DEC-10
Diclofenac SodiumPhysicians Total Care, Inc.14-JAN-11
Diclofenac Sodium Bryant Ranch Prepack14-JAN-11
Diclofenac SodiumPhysicians Total Care, Inc.14-JAN-11
Diclofenac SodiumPhysicians Total Care, Inc.31-JAN-11
CataflamNovartis Pharmaceuticals Corporation23-FEB-11
VoltarenxrNovartis Pharmaceuticals Corporation23-FEB-11
Diclofenac Sodium AvKARE, Inc.04-MAR-11
Diclofenac SodiumActavis Elizabeth LLC31-MAR-11
Diclofenac Sodium PD-Rx Pharmaceuticals, Inc.31-MAR-11
Diclofenac SodiumCardinal Health16-MAY-11
Diclofenac Sodium REMEDYREPACK INC. 02-JUN-11
Diclofenac PotassiumPD-Rx Pharmaceuticals, Inc.02-JUN-11
Diclofenac SodiumUnit Dose Services06-JUN-11
Diclofenac SodiumMcKesson Packaging Services a business unit of McKesson Corporation01-JUL-11
Diclofenac SodiumRebel Distributors Corp22-JUL-11
ArthrotecPD-Rx Pharmaceuticals, Inc.28-JUL-11
Diclofenac SodiumFalcon Pharmaceuticals, Ltd.19-AUG-11
Diclofenac Sodium Unit Dose Services01-SEP-11
Diclofenac SodiumPreferred Pharmaceuticals, Inc01-SEP-11
Diclofenac SodiumPack Pharmaceuticals, LLC01-SEP-11
Diclofenac Sodiumextended-releaseSt Marys Medical Park Pharmacy08-SEP-11
Diclofenac SodiumPack Pharmaceuticals, LLC19-SEP-11
Diclofenac SodiumPreferred Pharmaceuticals, Inc19-SEP-11
Diclofenac SodiumPD-Rx Pharmaceuticals, Inc.27-SEP-11
Diclofenac PotassiumH.J. Harkins Company, Inc.17-OCT-11
Diclofenac SodiumH.J. Harkins Company, Inc.27-OCT-11
Diclofenac PotassiumSandoz Inc28-OCT-11
FlectorUnit Dose Services01-NOV-11
Diclofenac PotassiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC05-DEC-11
Diclofenac SodiumRebel Distributors Corp13-DEC-11
DiclofenacAkorn, Inc.22-DEC-11
ArthrotecPhysicians Total Care, Inc.17-JAN-12
FlectorH.J. Harkins Company, Inc.19-JAN-12
Diclofenac Sodiumdelayed ReleaseRebel Distributors Corp24-JAN-12
Diclofenac Sodium Delayed ReleaseWatson Pharma, Inc.27-JAN-12
Diclofenac SodiumPACK Pharmaceuticals, LLC02-FEB-12
Diclofenac SodiumSTAT Rx USA LLC21-FEB-12
FlectorSTAT Rx USA LLC21-FEB-12
ArthrotecLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-FEB-12
Diclofenac Sodium REMEDYREPACK INC. 02-MAR-12
Diclofenac SodiumREMEDYREPACK INC. 27-MAR-12
Diclofenac Sodium REMEDYREPACK INC. 28-MAR-12
CambiaNautilus Neurosciences, Inc.29-MAR-12
Diclofenac PotassiumREMEDYREPACK INC. 30-MAR-12
Diclofenac Sodium Delayed ReleaseLake Erie Medical & Surgical Supply DBA Quality Care Products LLC10-APR-12
Diclofenac Sodium H.J. Harkins Company, Inc.19-APR-12
Diclofenac SodiumerPreferred Pharmaceuticals, Inc.04-JUN-12
Diclofenac Sodium And MisoprostolGreenstone LLC12-JUN-12
ArthrotecSTAT Rx USA LLC13-JUN-12
Diclofenac Sodium Delayed Release Carlsbad Technology, Inc.15-JUN-12
ZipsorXanodyne Pharmaceuticals, Inc.25-JUN-12
Diclofenac Sodium Aphena Pharma Solutions - Tennessee, Inc.05-JUL-12
Diclofenac SodiumAmerican Health Packaging10-JUL-12
FlectorRebel Distributors Corp17-JUL-12
Diclofenac Sodium And MisoprostolWatson Laboratories, Inc.17-JUL-12
Diclofenac SodiumAphena Pharma Solutions - Tennessee, Inc.19-JUL-12
Diclofenac Sodiumextended-releaseMedsource Pharmaceuticals24-JUL-12
Diclofenac PotassiumMylan Pharmaceuticals Inc.25-JUL-12
Diclofenac SodiumWatson Laboratories, Inc.30-JUL-12
ZipsorDepomed, Inc.31-JUL-12
Diclofenac SodiumTEVA Pharmaceuticals USA Inc.07-AUG-12
Diclofenac PotassiumTeva Pharmaceuticals USA Inc10-AUG-12
Diclofenac PotassiumApotex Corp25-SEP-12
Voltaren Novartis Pharmaceutical Corporation01-OCT-12
Diclofenac Sodium Delayed ReleaseBryant Ranch Prepack23-OCT-12
Diclofenac SodiumBryant Ranch Prepack24-OCT-12
Diclofenac SodiumSandoz Inc07-NOV-12
PennsaidLake Erie Medical DBA Quality Care Products LLC15-NOV-12
Diclofenac Sodium And Misoprostol AvKARE, Inc.14-DEC-12
FlectorKing Pharmaceuticals, Inc.20-DEC-12
FlectorBryant Ranch Prepack18-JAN-13
Diclofenac SodiumBausch & Lomb Incorporated04-FEB-13
Diclofenac PotassiumLake Erie Medical DBA Quality Care Products LLC07-FEB-13
Diclofenac SodiumLake Erie Medical DBA Quality Care Products LLC07-FEB-13
Diclofenac SodiumNCS HealthCare of KY, Inc dba Vangard Labs26-FEB-13
ArthrotecG.D. Searle LLC Division of Pfizer Inc13-MAR-13
Diclofenac Sodium And MisoprostolWatson Laboratories, Inc.03-MAY-13
Diclofenac SodiumE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.06-MAY-13

Diclofenac Case Reports

What Diclofenac safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Diclofenac. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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