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Diclofenac (Diclofenac) - Side Effect Reports to FDA

 
 



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 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

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 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 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 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 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 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



Possible Diclofenac side effects in male

Reported by a physician from Montenegro on 2012-07-20

Patient: male, weighing 86.3 kg (189.9 pounds)

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-07

Diclofenac
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    End date: 2012-07-02

Sulfasalazine
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-01-01

Other drugs received by patient: Ranisan; Captopril; Captopril; Methotrexate; Folan



Possible Diclofenac side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-20

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Osteoporosis, Arthralgia, Pulmonary Sarcoidosis, Epilepsy

Drug(s) suspected as cause:
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; Alendronate Sodium; Lamotrigine; Simvastatin; Omeprazole Magnesium

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