This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cataflam (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 (28)
Death (3)
Life Threatening Events (2)
Reports by Reaction Type
Pain (4),
Pain in Extremity (4),
Abdominal Discomfort (3),
Dizziness (3),
Arthralgia (3),
Eye Swelling (3),
Gait Disturbance (3),
Hypersensitivity (2),
Oligohydramnios (2),
Foetal Exposure During Pregnancy (2),
Deafness (2),
Headache (2)
Possible Cataflam side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-08
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Hypertension
Drug(s) suspected as cause:
Cataflam
Dosage: unk, unk
Indication: Contusion
Cataflam
Dosage: 5 sprays, unk
Possible Cataflam side effects in 15 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-02
Patient: 15 year old female
Reactions: Pharyngeal Oedema, Dysphagia, Pyrexia, Oropharyngeal Pain
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-07-31
Patient: male, weighing 89.0 kg (195.8 pounds)
Reactions: Thrombosis, Nasopharyngitis, Nasal Discomfort, Oral Pain, Rhinalgia, Rhinorrhoea, Epistaxis
Drug(s) suspected as cause:
Cataflam
Dosage: 50 mg, q8h
Indication: Tooth Extraction
Start date: 2005-01-01
Cataflam
Dosage: 50 mg, q8h
Administration route: Oral
Start date: 2012-07-26
End date: 2012-07-27
Cataflam
Dosage: 50 mg, bid
Administration route: Oral
Indication: Oral Pain
Start date: 2012-07-25
Penicillin
Dosage: 500 mg, q12h
Start date: 2005-01-01
Possible Cataflam side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-07-30
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Hypersensitivity, Eye Swelling, Headache
Drug(s) suspected as cause:
Cataflam
Other drugs received by patient: Cyproterone Acetate / Ethinylestradiol
Possible Cataflam side effects in 39 year old female
Reported by a consumer/non-health professional from Brazil on 2012-07-30
Patient: 39 year old female
Reactions: Drug Dispensing Error
Drug(s) suspected as cause:
Cataflam
Dosage: 50 mg, unk
Indication: Neck Pain
Cataflam
Dosage: 50 mg, unk
Indication: Neck Pain
Possible Cataflam side effects in 62 year old male
Reported by a consumer/non-health professional from Brazil on 2012-07-25
Patient: 62 year old male
Reactions: Drug Effect Decreased, Hypersensitivity, Application Site Pustules, Pain, Application Site Swelling, Expired Drug Administered, Torticollis, Application Site Rash, Application Site Erythema
Drug(s) suspected as cause:
Cataflam
Dosage: 1 df, tid (1 tablet every 8 hours)
Administration route: Oral
Indication: Oropharyngeal Pain
Cataflam
Dosage: 60 g, unk
Indication: Pain
End date: 2012-07-18
Possible Cataflam side effects in female
Reported by a consumer/non-health professional from Venezuela on 2012-07-25
Patient: female
Reactions: Drug Ineffective, Pharyngitis
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in 65 year old male
Reported by a health professional (non-physician/pharmacist) from Singapore on 2012-07-09
Patient: 65 year old male
Reactions: Dyspnoea, Eye Swelling
Drug(s) suspected as cause:
Aspirin
Administration route: Oral
Cataflam
Possible Cataflam side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-07-03
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Eye Swelling, Headache
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-06-29
Patient: female
Reactions: Pain, Adverse Event
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-06-14
Patient: female, weighing 79.0 kg (173.8 pounds)
Reactions: Procedural Pain, Renal Disorder, Osteoporosis, Arthralgia, Nausea, Pain in Extremity, Muscular Weakness, Gait Disturbance
Drug(s) suspected as cause:
Cataflam
Dosage: 50 mg, qd
Administration route: Oral
Indication: Pain
Voltaren
Dosage: 50 mg, qd
Administration route: Oral
Other drugs received by patient: Lysine; Acetaminophen W / Codeine; Dipyrone TAB
Possible Cataflam side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-30
Patient: female, weighing 69.0 kg (151.8 pounds)
Reactions: Uterine Inflammation
Drug(s) suspected as cause:
Cataflam
Other drugs received by patient: Gestinol; Puran
Possible Cataflam side effects in female
Reported by a physician from United States on 2012-04-05
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Albuterol
Dosage: unk
Aspirin
Dosage: unk
Cataflam
Dosage: unk
Clavulanate Potassium
Dosage: unk
Imdur
Dosage: unk
Lyrica
Dosage: unk
Methotrexate Sodium
Dosage: unk
Motrin
Nitroglycerin
Dosage: unk
Potassium Pencillin G
Dosage: unk
Possible Cataflam side effects in 3 year old
Reported by a health professional (non-physician/pharmacist) from Indonesia on 2012-02-29
Patient: 3 year old , weighing 11.0 kg (24.2 pounds)
Reactions: Vomiting, Cyanosis, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in 65 year old male
Reported by a consumer/non-health professional from Brazil on 2012-01-24
Patient: 65 year old male
Reactions: Anxiety, Pain in Extremity, Arthralgia, Pain, Bone Pain, Condition Aggravated, Gait Disturbance
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cataflam
Other drugs received by patient: Massageol; Torsilax
Possible Cataflam side effects in 92 year old male
Reported by a consumer/non-health professional from Brazil on 2011-12-21
Patient: 92 year old male
Reactions: Dyspnoea, Gastrointestinal Disorder, Hypertension
Drug(s) suspected as cause:
Cataflam
Other drugs received by patient: Acetylsalicylic Acid SRT
Possible Cataflam side effects in male
Reported by a individual with unspecified qualification from Brazil on 2011-12-15
Patient: male
Reactions: Deafness
Drug(s) suspected as cause:
Cataflam
Dosage: 60 g, unk
Diovan
Dosage: 320 mg, unk
Diovan
Dosage: 160 mg, unk
Diovan
Dosage: 160 mg, unk
Diovan
Dosage: 80 mg, unk
Diovan HCT
Dosage: 1 df (160 mg vals and 12.5 mg hct), unk
Diovan HCT
Dosage: 1 df (320 mg vals and 12.5 mg hct)), unk
Other drugs received by patient: Exelon
Possible Cataflam side effects in male
Reported by a physician from Belgium on 2011-12-02
Patient: male
Reactions: Oligohydramnios, Intra-Uterine Death, Umbilical Cord Around Neck, Pulmonary Congestion, Foetal Exposure During Pregnancy, Asphyxia, Adrenal Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in male
Reported by a physician from Belgium on 2011-12-01
Patient: male
Reactions: Oligohydramnios, Intra-Uterine Death, Umbilical Cord Around Neck, Foetal Exposure During Pregnancy, Pulmonary Congestion, Adrenal Disorder, Asphyxia
Adverse event resulted in: death
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in 49 year old female
Reported by a consumer/non-health professional from Brazil on 2011-11-16
Patient: 49 year old female
Reactions: Bladder Pain
Drug(s) suspected as cause:
Cataflam
Dosage: 75 mg, 1 suppository daily
Indication: Bladder Pain
Start date: 2011-03-30
Diclofenac Sodium
Dosage: 50 mg, 2 suppositories daily
Indication: Bladder Pain
Morphine Sulfate
Possible Cataflam side effects in male
Reported by a pharmacist from Malta on 2011-11-10
Patient: male
Reactions: Abdominal Discomfort, Dizziness
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in male
Reported by a pharmacist from Malta on 2011-11-04
Patient: male
Reactions: Abdominal Discomfort, Dizziness
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in male
Reported by a individual with unspecified qualification from Brazil on 2011-11-04
Patient: male
Reactions: Deafness
Drug(s) suspected as cause:
Cataflam
Dosage: 60 g, unk
Diovan
Dosage: 160 mg, unk
Diovan
Dosage: 320 mg, unk
Diovan
Dosage: 160 mg, unk
Diovan
Dosage: 80 mg, unk
Diovan HCT
Dosage: 1 df (160 mg vals and 12.5 mg hct), unk
Diovan HCT
Dosage: 1 df (320 mg vals and 12.5 mg hct)), unk
Exelon
Dosage: 9mg/5cm2, unk
Possible Cataflam side effects in male
Reported by a pharmacist from Malta on 2011-11-04
Patient: male
Reactions: Abdominal Discomfort, Dizziness
Drug(s) suspected as cause:
Cataflam
Possible Cataflam side effects in 65 year old male
Reported by a consumer/non-health professional from Brazil on 2011-11-01
Patient: 65 year old male
Reactions: Arthralgia, Pain in Extremity, Pain, Condition Aggravated, Gait Disturbance
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cataflam
Other drugs received by patient: Massageol; Torsilax
Possible Cataflam side effects in 24 year old female
Reported by a consumer/non-health professional from Brazil on 2011-10-31
Patient: 24 year old female
Reactions: Anxiety, Migraine, Vomiting, Dehydration
Drug(s) suspected as cause:
Cataflam
Dosage: unk ukn, unk
Administration route: Oral
Indication: Migraine
Diclofenac Sodium
Dosage: 50 mg, unk
Indication: Migraine
Other drugs received by patient: Naratriptan; Omeprazole
Possible Cataflam side effects in 83 year old female
Reported by a health professional (non-physician/pharmacist) from Hungary on 2011-10-20
Patient: 83 year old female
Reactions: Haemorrhage, Pain in Extremity, Oedema Peripheral, International Normalised Ratio Increased, Drug Interaction
Drug(s) suspected as cause:
Cataflam
Other drugs received by patient possibly interacting with the suspect drug: Atorvastatin
Dosage: unk
Simvastatin
Sintrom
Other drugs received by patient: Perindopril Erbumine; Indapamide; Metformin HCL; Allopurinol
Possible Cataflam side effects in 3 month old female
Reported by a pharmacist from Costa Rica on 2011-10-19
Patient: 3 month old female
Reactions: Death, Skin Discolouration
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cataflam
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