This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Diclofenac and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (190)
Death (29)
Life Threatening Events (14)
Disability (2)
Reports by Reaction Type
Renal Failure Acute (27),
Vomiting (25),
Nausea (22),
Multi-Organ Failure (18),
Abdominal Pain (14),
Blood Bilirubin Increased (12),
Somnolence (12),
Abdominal Pain Upper (12),
Melaena (12),
Anaemia (12),
Gastritis (11),
Blood Creatinine Increased (11)
Below are a few examples of reports where side effects / adverse reactions may be related to Diclofenac. For a complete list or a specific selection of reports, please use the links above.
Possible Diclofenac side effects in
Reported by a consumer/non-health professional from Brazil on 2012-08-20
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Acetaminophen
Indication: Product Used FOR Unknown Indication
Acetaminophen
Diclofenac
Indication: Product Used FOR Unknown Indication
Duragesic-100
Indication: Product Used FOR Unknown Indication
Possible Diclofenac side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-17
Patient: 73 year old female
Reactions: Renal Failure, Acute Phosphate Nephropathy, Renal Failure Acute
Drug(s) suspected as cause:
Calcium
Indication: Osteoporosis
Colophos
Indication: Colonoscopy
Diclofenac
Indication: Flank Pain
Other drugs received by patient: Alendronate Sodium; Carbamazepine
Possible Diclofenac side effects in 37 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17
Patient: 37 year old male
Reactions: Abdominal Pain, Duodenitis, Peptic Ulcer, Helicobacter Infection, Melaena, Abdominal Pain Upper, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Administration route: Oral
Indication: Back Pain
Start date: 2009-05-01
End date: 2011-09-30
Ibuprofen
Administration route: Oral
Ibuprofen
Administration route: Oral
Indication: Back Pain
Start date: 2011-06-01
End date: 2011-09-30
Other drugs received by patient: Amitriptyline HCL
Possible Diclofenac side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-16
Patient: female
Reactions: Colitis Ischaemic, Abdominal Pain, Large Intestine Perforation, Abdominal Rigidity, Diarrhoea Haemorrhagic, Chronic Obstructive Pulmonary Disease, Abdominal Tenderness
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Diclofenac
Possible Diclofenac side effects in 37 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-14
Patient: 37 year old male
Reactions: Abdominal Pain, Duodenitis, Peptic Ulcer, Helicobacter Test Positive, Melaena, Abdominal Pain Upper, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Dosage: 50 mg, 3x/day
Administration route: Oral
Indication: Back Pain
Start date: 2009-05-01
End date: 2011-09-30
Ibuprofen
Dosage: 400 mg, 3x/day
Administration route: Oral
Indication: Back Pain
Start date: 2011-06-01
End date: 2011-09-30
Other drugs received by patient: Amitriptyline
Possible Diclofenac side effects in 32 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-13
Patient: 32 year old female
Reactions: Defaecation Urgency, Pain, Constipation
Drug(s) suspected as cause:
Acetaminophen and Hydrocodone Ditartrate
Dosage: 1 df, four times a day
Administration route: Oral
Indication: Postoperative Analgesia
Start date: 2012-07-25
End date: 2012-07-30
Amoxicillin and Clavulanate Potassium
Dosage: 1 df, tid
Administration route: Oral
Indication: Antibiotic Prophylaxis
Start date: 2012-07-25
Diclofenac
Dosage: 50 mg, tid
Administration route: Oral
Indication: Postoperative Analgesia
Start date: 2012-07-25
Other drugs received by patient: Ferrous Sulfate TAB; Flucloxacillin; Acetaminophen
Possible Diclofenac side effects in 32 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-10
Patient: 32 year old female
Reactions: Defaecation Urgency, Pain, Constipation
Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
Dosage: 1 df, tid
Administration route: Oral
Indication: Antibiotic Prophylaxis
Start date: 2012-07-25
CO-Dydramol
Dosage: 1 df, four times a day
Administration route: Oral
Indication: Postoperative Analgesia
Start date: 2012-07-25
End date: 2012-07-30
Diclofenac
Dosage: 50 mg, tid
Administration route: Oral
Indication: Postoperative Analgesia
Start date: 2012-07-25
Other drugs received by patient: Ferrous Sulfate TAB; Flucloxacillin; Acetaminophen
Possible Diclofenac side effects in 50 year old male
Reported by a consumer/non-health professional from Germany on 2012-08-09
Patient: 50 year old male, weighing 94.0 kg (206.8 pounds)
Reactions: Thrombosis, Impaired Work Ability, Pain, Fracture Nonunion
Drug(s) suspected as cause:
Diclofenac
Indication: Product Used FOR Unknown Indication
Xarelto
Administration route: Oral
Start date: 2012-01-30
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2012-02-01
Xarelto
Administration route: Oral
Start date: 2012-01-29
End date: 2012-01-29
Xarelto
Administration route: Oral
Start date: 2012-01-30
Xarelto
Administration route: Oral
Indication: Lower Limb Fracture
Start date: 2012-02-01
Xarelto
Administration route: Oral
Start date: 2012-01-29
End date: 2012-01-29
Possible Diclofenac side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-08-07
Patient: 56 year old male
Reactions: Haemoptysis, Pulmonary Oedema
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient: Pravastatin; Losartan
Possible Diclofenac side effects in 19 year old male
Reported by a physician from United Kingdom on 2012-07-31
Patient: 19 year old male
Reactions: Cardio-Respiratory Arrest, Intentional Overdose, Convulsion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Diclofenac
Dosage: 14x50mg tablets
Administration route: Oral
Indication: Intentional Overdose
Nefopam
Dosage: 60x30mg tablets
Administration route: Oral
Indication: Intentional Overdose
Possible Diclofenac side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30
Patient:
Reactions: Rhabdomyolysis, Myopathy, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Administration route: Oral
Zocor
Administration route: Oral
Other drugs received by patient: Cinnarizine; Glucosamine; Sildenafil Citrate
Possible Diclofenac side effects in female
Reported by a consumer/non-health professional from Canada on 2012-07-30
Patient: female
Reactions: White Blood Cell Count Decreased, Dyspnoea, Nausea, Drug Interaction, Muscular Weakness, Pyrexia, Headache, Multiple Sclerosis Relapse, Abdominal Discomfort, Fatigue, Abnormal Sensation in Eye, Eye Swelling, Vision Blurred, Neutropenia, Lymphocyte Count Decreased
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient possibly interacting with the suspect drug: Escitalopram
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2012-05-15
End date: 2012-06-12
Other drugs received by patient: Baclofen; Clonazepam; Gabapentin; Extra Strength Tylenol; Vesicare; Water Pills; Nexium; Amitriptyline Hydrochloride
Possible Diclofenac side effects in 38 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-07-30
Patient: 38 year old female
Reactions: Oligohydramnios, Maternal Exposure During Pregnancy, Breech Presentation, PRE-Eclampsia, Hypertension
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient: Diazepam; Acetaminophen; Meperidine HCL; Scopolamine; Metamizol; Dipyrone INJ
Possible Diclofenac side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-30
Patient: female
Reactions: White Blood Cell Count Decreased, Dyspnoea, Nausea, Muscular Weakness, Drug Interaction, Pyrexia, Headache, Multiple Sclerosis Relapse, Abdominal Discomfort, Fatigue, Abnormal Sensation in Eye, Vision Blurred, Eye Swelling, Neutropenia, Lymphocyte Count Decreased
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient possibly interacting with the suspect drug: Escitalopram
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2012-05-15
End date: 2012-06-12
Other drugs received by patient: Baclofen; Nexium; Vesicare; Extra Strength Tylenol; Amitriptyline Hydrochloride; Water Pills; Clonazepam; Gabapentin
Possible Diclofenac side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-30
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Pulmonary Sarcoidosis, Osteoporosis, Arthralgia, Epilepsy
Drug(s) suspected as cause:
Diclofenac
Dosage: 150 mg, daily
Administration route: Oral
Indication: Osteoporosis
Start date: 2005-11-10
Prednisolone
Dosage: 10 mg, daily
Administration route: Oral
Indication: Sarcoidosis
Start date: 2005-11-20
Other drugs received by patient: Alendronate Sodium; Lamotrigine; Omeprazole Magnesium; Azathioprine; Simvastatin
Possible Diclofenac side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-30
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Gait Disturbance
Drug(s) suspected as cause:
Carbamazepine
Dosage: 150 mg, daily
Administration route: Oral
Indication: Epilepsy
Start date: 2011-11-09
Diclofenac
Dosage: 150 mg, daily
Administration route: Oral
Indication: Osteoporosis
Start date: 2005-11-10
Prednisolone
Dosage: 10 mg, daily
Administration route: Oral
Indication: Sarcoidosis
Start date: 2005-11-20
Other drugs received by patient: Azathioprine; Alendronate Sodium; Omeprazole Magnesium; Simvastatin; Lamotrigine
Possible Diclofenac side effects in 38 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-27
Patient: 38 year old female
Reactions: Oligohydramnios, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient: Buscapina; Dipyrone INJ; Acetaminophen; Diazepam; Meperidine HCL
Possible Diclofenac side effects in female
Reported by a physician from United Kingdom on 2012-07-27
Patient: female
Reactions: Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient: Sulfasalazine; Alendronate Sodium; Ferrous Sulfate TAB; Tramadol Hydrochloride; Acitretin; Omeprazole
Possible Diclofenac side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27
Patient: female, weighing 81.0 kg (178.2 pounds)
Reactions: Pneumonia, Metastases To Spine, Somnolence
Adverse event resulted in: death
Drug(s) suspected as cause:
Carbamazepine
Dosage: 200 mg, udaily
Administration route: Oral
Indication: Analgesic Therapy
Diclofenac
Dosage: 100 mg, daily
Indication: Analgesic Therapy
Possible Diclofenac side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-27
Patient: female
Reactions: Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient: Tramadol Hydrochloride; Ferrous Sulfate TAB; Acitretin; Sulfasalazine; Omeprazole; Alendronate Sodium
Possible Diclofenac side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26
Patient: 33 year old female
Reactions: Vomiting, Antinuclear Antibody, Pleurisy, Pancytopenia, Headache, Hypokinesia, Mixed Connective Tissue Disease, Epigastric Discomfort, C-Reactive Protein Increased, Leukopenia, Meningitis Aseptic
Drug(s) suspected as cause:
Celecoxib
Administration route: Oral
Diclofenac
Indication: Oropharyngeal Pain
Possible Diclofenac side effects in 65 year old female
Reported by a pharmacist from United Kingdom on 2012-07-26
Patient: 65 year old female
Reactions: Confusional State, Dehydration, Toxicity To Various Agents, Somnolence, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Dosage: 50 mg, 3x/day
Administration route: Oral
End date: 2012-03-08
Losartan Potassium
Dosage: unk
Administration route: Oral
End date: 2012-03-08
Metolazone
Dosage: unk
Administration route: Oral
End date: 2012-03-08
Morphine Sulfate
Dosage: 5 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2012-03-04
End date: 2012-03-08
Other drugs received by patient: Omeprazole; Pregabalin; Salbutamol; Citalopram; Paracetamol
Possible Diclofenac side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26
Patient: 33 year old female
Reactions: Vomiting, Pleurisy, Antinuclear Antibody, Pancytopenia, Headache, Hypokinesia, C-Reactive Protein Increased, Mixed Connective Tissue Disease, Epigastric Discomfort, Leukopenia, Meningitis Aseptic
Drug(s) suspected as cause:
Celecoxib
Administration route: Oral
Diclofenac
Indication: Oropharyngeal Pain
Possible Diclofenac side effects in 81 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-25
Patient: 81 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Troponin I Increased, Bradycardia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Other drugs received by patient possibly interacting with the suspect drug: Atenolol
Other drugs received by patient: Finasteride; Acetaminophen; Codeine Sulfate; Aspirin
Possible Diclofenac side effects in female
Reported by a physician from Brazil on 2012-07-24
Patient: female, weighing 51.0 kg (112.2 pounds)
Reactions: Gingivitis, Urticaria
Drug(s) suspected as cause:
Amoxicillin
Indication: Dental Care
Diclofenac
Indication: Dental Care
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-11-01
Other drugs received by patient: Levonorgestrel and Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol
Possible Diclofenac side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-23
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Gait Disturbance
Drug(s) suspected as cause:
Carbamazepine
Dosage: 150 mg, unk
Administration route: Oral
Indication: Epilepsy
Start date: 2011-11-09
Diclofenac
Dosage: 150 mg, unk
Administration route: Oral
Indication: Osteoporosis
Start date: 2005-11-10
Prednisolone
Dosage: 10 mg, unk
Administration route: Oral
Indication: Sarcoidosis
Start date: 2005-11-20
Other drugs received by patient: Alendronate Sodium; Omeprazole Magnesium; Simvastatin; Azathioprine; Lamotrigine
Possible Diclofenac side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-23
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Gait Disturbance
Drug(s) suspected as cause:
Carbamazepine
Dosage: 150 mg, unk
Administration route: Oral
Indication: Epilepsy
Start date: 2011-11-09
Diclofenac
Dosage: 150 mg, unk
Administration route: Oral
Indication: Osteoporosis
Start date: 2005-11-10
Prednisolone
Dosage: 10 mg, unk
Administration route: Oral
Indication: Sarcoidosis
Start date: 2005-11-20
Other drugs received by patient: Azathioprine; Omeprazole Magnesium; Alendronate Sodium; Lamotrigine; Simvastatin
Possible Diclofenac side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from Greece on 2012-07-20
Patient: 61 year old female
Reactions: Abdominal Pain, Vomiting, Metabolic Acidosis, Hyperkalaemia, Nausea, Kussmaul Respiration, Disorientation, Somnolence, Blood Lactic Acid Increased, Abdominal Discomfort, Renal Impairment, Oliguria, Blood Pressure Decreased, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Dosage: 75 mg, daily
Administration route: Oral
Indication: Joint Injury
Metformin Hydrochloride
Dosage: 1700 mg, daily
Other drugs received by patient: Hydrochlorothiazide; Enalapril Maleate; Glimepiride
Possible Diclofenac side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from Greece on 2012-07-20
Patient: 61 year old female
Reactions: Abdominal Pain, Metabolic Acidosis, Vomiting, Hyperkalaemia, Nausea, Kussmaul Respiration, Disorientation, Somnolence, Blood Lactic Acid Increased, Abdominal Discomfort, Renal Impairment, Oliguria, Blood Pressure Decreased, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac
Dosage: 75 mg, daily
Administration route: Oral
Indication: Joint Injury
Metformin Hydrochloride
Dosage: 1700 mg, daily
Other drugs received by patient: Glimepiride; Hydrochlorothiazide; Enalapril Maleate
Possible Diclofenac side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-20
Patient: 59 year old female
Reactions: Blood Pressure Increased, Retinal Degeneration, Tonic Clonic Movements, Headache, Haemoglobin Decreased, Retinopathy Hypertensive, Posterior Reversible Encephalopathy Syndrome, Visual Impairment, Respiratory Arrest, Blindness
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Diclofenac
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