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Index of reports
> Cases resulting in a serious event (19)
Below is the selection of adverse event reports related to Cataflam (Diclofenac) that includes cases resulting in a serious event.
Adverse event in 8 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Venezuela on 2007-10-29
Patient: 8 year old female
Adverse reactions / side effects: Epistaxis
Suspect drug(s):
Cataflam (Diclofenac)
Adverse event in 3 year old male receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-10-18
Patient: 3 year old male, weighing 16.0 kg (35.2 pounds)
Adverse reactions / side effects: Drug Ineffective, Bronchitis
Suspect drug(s):
Cataflam (Diclofenac)
Adverse event in 13 year old female receiving Cataflam (Diclofenac)
Reported by a physician from Brazil on 2007-10-12
Patient: 13 year old female, weighing 38.0 kg (83.6 pounds)
Adverse reactions / side effects: LIP Swelling, Pharyngeal Oedema, Dyspnoea, Drug Hypersensitivity, Eye Swelling, Exposure TO Toxic Agent
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Cataflam
Dosage: 30 drops/day
Administration route: Oral
Indication: Pharyngolaryngeal Pain
Start date: 2007-08-07
Cataflam
Dosage: 30 drp, tid
Administration route: Oral
Start date: 2007-08-08
End date: 2007-08-08
Pesticide
Other drugs received by patient: Dipyrone
Adverse event in 13 year old female receiving Cataflam (Diclofenac)
Reported by a physician from Brazil on 2007-10-10
Patient: 13 year old female, weighing 38.0 kg (83.6 pounds)
Adverse reactions / side effects: LIP Swelling, Pharyngeal Oedema, Dyspnoea, Drug Hypersensitivity, Eye Swelling, Exposure TO Toxic Agent
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Cataflam
Dosage: 30 drops/day
Administration route: Oral
Indication: Pharyngolaryngeal Pain
Start date: 2007-08-07
Cataflam
Dosage: 30 drp, tid
Administration route: Oral
Start date: 2007-08-08
End date: 2007-08-08
Pesticide
Other drugs received by patient: Dipyrone
Adverse event in 23 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional on 2007-10-03
Patient: 23 year old female
Adverse reactions / side effects: Vaginal Haemorrhage
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Perlutan
Adverse event in 5 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-10-02
Patient: 5 year old female, weighing 19.0 kg (41.8 pounds)
Adverse reactions / side effects: Dyspnoea, Vomiting, Pyrexia
Suspect drug(s):
Cataflam
Dosage: 7 gtt, tid
Administration route: Oral
Indication: Pharyngolaryngeal Pain
Start date: 2007-09-18
End date: 2007-09-19
Cataflam
Dosage: 18 gtt, tid
Administration route: Oral
Start date: 2007-09-19
Other drugs received by patient: Berotec; Atrovent; Fluid / Electrolyte Replacement Therapy; Cetotiphen; Aminovac; Amoxicillin; Dexamethasone 0.5mg TAB
Adverse event in 32 year old male receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Malta on 2007-07-27
Patient: 32 year old male
Adverse reactions / side effects: Dysarthria, Somnolence
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Voltaren
Adverse event in 27 year old male receiving Cataflam (Diclofenac)
Reported by a physician from Guatemala on 2007-06-28
Patient: 27 year old male
Adverse reactions / side effects: Autonomic Nervous System Imbalance, Hypertension
Suspect drug(s):
Sirdalud
Dosage: 4 mg, q8h
Administration route: Oral
Indication: Muscle Spasms
Start date: 2007-05-01
Cataflam
Dosage: 50 mg/day prn
Administration route: Oral
Indication: Pain
Other drugs received by patient: Nimotop; Ranitidine HCL; Dorixina Relax
Adverse event in 65 year old male receiving Cataflam (Diclofenac)
Reported by a physician from Ecuador on 2007-06-27
Patient: 65 year old male
Adverse reactions / side effects: Drug Toxicity, Pruritus, Syncope, Vision Blurred, Rash
Suspect drug(s):
Cataflam
Dosage: 50 mg, q12h
Administration route: Oral
Indication: Infection
Start date: 2007-06-18
Diclofenac
Indication: Infection
Other drugs received by patient: Biodroxil; Corticosteroid NOS
Adverse event in 42 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Venezuela on 2007-06-15
Patient: 42 year old female
Adverse reactions / side effects: Neuroma, Musculoskeletal Discomfort, Musculoskeletal Chest Pain, Abdominal Discomfort, Hepatomegaly, Upper Respiratory Tract Infection, Neurectomy, Abdominal Distension, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Zelmac / HTF 919a
Dosage: 6 mg, bid
Administration route: Oral
Indication: Irritable Bowel Syndrome
Start date: 2001-01-01
Dolomax
End date: 2007-01-09
Cataflam
Dosage: 100 mg, qd
Administration route: Oral
End date: 2007-01-09
Adverse event in 1 year old female receiving Cataflam (Diclofenac)
Reported by a physician from Panama on 2007-06-07
Patient: 1 year old female
Adverse reactions / side effects: Vaginal Haemorrhage
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Tempra; Enteroglimin
Adverse event in 3 year old male receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-06-06
Patient: 3 year old male, weighing 12.0 kg (26.4 pounds)
Adverse reactions / side effects: Peripheral Coldness, Faeces Pale, Vomiting, Hypotension, Poisoning, Body Temperature Decreased, Depressed Mood
Adverse event resulted in: hospitalization
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Carbocisteine; Antibiotics
Adverse event in 5 year old male receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-05-31
Patient: 5 year old male, weighing 15.0 kg (33.0 pounds)
Adverse reactions / side effects: Laziness, Vomiting, Pneumonia, Dyspnoea, Nasopharyngitis, Hyponatraemia, Pyrexia
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Rivotril; Valproate Sodium
Adverse event in 4 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-05-30
Patient: 4 year old female, weighing 15.0 kg (33.0 pounds)
Adverse reactions / side effects: Impetigo, Pharyngolaryngeal Pain, Pyrexia
Suspect drug(s):
Cataflam (Diclofenac)
Adverse event in 3 year old male receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-05-22
Patient: 3 year old male, weighing 12.0 kg (26.4 pounds)
Adverse reactions / side effects: Peripheral Coldness, Faeces Pale, Vomiting, Hypotension, Poisoning, Body Temperature Decreased, Depressed Mood
Adverse event resulted in: hospitalization
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Carbocisteine
Adverse event in male receiving Cataflam (Diclofenac)
Reported by a health professional (non-physician/pharmacist) from Venezuela on 2007-05-14
Patient: male, weighing 9.3 kg (20.5 pounds)
Adverse reactions / side effects: Hypothermia
Adverse event resulted in: hospitalization
Suspect drug(s):
Cataflam (Diclofenac)
Other drugs received by patient: Nipe; Amoxicillin; Dextromethorphan; Tylenol
Adverse event in receiving Cataflam (Diclofenac)
Reported by a physician from Guatemala on 2007-04-06
Patient:
Adverse reactions / side effects: Blood Urea Increased, Urine Abnormality, Blood Creatinine Increased
Suspect drug(s):
Cataflam (Diclofenac)
Adverse event in 66 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Brazil on 2007-04-02
Patient: 66 year old female, weighing 77.0 kg (169.4 pounds)
Adverse reactions / side effects: Chondropathy
Suspect drug(s):
Voltaren
Dosage: 50 mg/day
Indication: Pain
Cataflam
Indication: Pain
Other drugs received by patient: Gluporiomin; Anador; Lisador
Adverse event in 42 year old female receiving Cataflam (Diclofenac)
Reported by a consumer/non-health professional from Venezuela on 2007-02-05
Patient: 42 year old female
Adverse reactions / side effects: Neuroma, Musculoskeletal Discomfort, Musculoskeletal Chest Pain, Abdominal Discomfort, Hepatomegaly, Upper Respiratory Tract Infection, Neurectomy, Abdominal Distension, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Zelmac / HTF 919a
Dosage: 6 mg, bid
Administration route: Oral
Indication: Irritable Bowel Syndrome
Start date: 2001-01-01
Dolomax
End date: 2007-01-09
Cataflam
Dosage: 100 mg, qd
Administration route: Oral
End date: 2007-01-09
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