Index of reports
> Cases with Haematemesis (28)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Naproxen where reactions include haematemesis. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Naproxen side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-06-26
Patient: 72 year old female
Reactions: Haemoglobin Decreased, Duodenal Ulcer, Melaena, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Omeprazole; Fostair; Senna-Mint WAF; Lactulose; Omeprazole; Bendroflumethiazide; Albuterol; Quinine Sulfate; Ramipril
Possible Naproxen side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-06-25
Patient: 70 year old female, weighing 57.2 kg (125.8 pounds)
Reactions: Oesophagitis, Upper Gastrointestinal Haemorrhage, Gastric Ulcer, Oesophageal Ulcer, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Prednisolone
Dosage: in the morning (10 mg, qd)
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Naproxen
Dosage: (500mg, 2 in -2) in the morning
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-05-13
Other drugs received by patient: Infumorph; Vitamin B Substances; Enoxaparin; Metoclopramide; Thiamine; Atenolol; Sertraline Hydrochloride; Omeprazole; Oxycodone HCL; Senna-Mint WAF; Oxybutynin; Calcichew D3; Diazepam; Acetaminophen; Alendronate Sodium; Folic Acid; Gabapentin
Possible Naproxen side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-22
Patient: 70 year old female, weighing 57.2 kg (125.8 pounds)
Reactions: Oesophagitis, Upper Gastrointestinal Haemorrhage, Gastric Ulcer, Oesophageal Ulcer, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: 500 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-05-13
Prednisolone
Dosage: 10 mg, qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Omeprazole; Vitamin B Complex CAP; Calcichew D3; Oxycodone HCL; Thiamine; Atenolol; Acetaminophen; Senna-Mint WAF; Sertraline Hydrochloride; Infumorph; Enoxaparin; Folic Acid; Gabapentin; Oxybutynin; Alendronate Sodium; Diazepam; Metoclopramide
Possible Naproxen side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-22
Patient: 69 year old male
Reactions: Haemoglobin Decreased, Gastrointestinal Haemorrhage, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-22
Patient: 72 year old female
Reactions: Haemoglobin Decreased, Duodenal Ulcer, Melaena, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Senna-Mint WAF; Lactulose; Quinine Sulfate; Ramipril; Albuterol; Bendroflumethiazide; Fostair; Omeprazole
Possible Naproxen side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-21
Patient: 72 year old female
Reactions: Haemoglobin Decreased, Duodenal Ulcer, Melaena, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Albuterol; Bendroflumethiazide; Fostair; Lactulose; Senna-Mint WAF; Omeprazole; Quinine Sulfate; Ramipril; Omeprazole
Possible Naproxen side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-21
Patient: 70 year old female
Reactions: Oesophagitis, Upper Gastrointestinal Haemorrhage, Oesophageal Ulcer, Gastric Ulcer, Gastritis, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Prednisolone
Dosage: 10 mg;qd;po
Administration route: Oral
Naproxen
Dosage: 500 mg;bid;po
Administration route: Oral
End date: 2012-05-13
Other drugs received by patient: Enoxaparin; Diazepam; Atenolol; Acetaminophen; Omeprazole; Vitamin B Substances; Infumorph; Sertraline Hydrochloride; Oxycodone HCL; Senna-Mint WAF; Gabapentin; Metoclopramide; Alendronate Sodium; Thiamine; Oxybutynin; Folic Acid; Calcichew D3
Possible Naproxen side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-20
Patient: 72 year old female
Reactions: Duodenal Ulcer, Melaena, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Quinine Sulfate; Lactulose; Ramipril; Senna-Mint WAF; Fostair; Albuterol Sulate; Omeprazole; Bendroflumethiazide
Possible Naproxen side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) on 2012-06-15
Patient: 72 year old female
Reactions: Haemoglobin Decreased, Duodenal Ulcer, Melaena, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Quinine Sulfate; Senna-Mint WAF; Lactulose; Omeprazole; Ramipril; Fostair (Beclometasone Dipropionate); Albuterol Sulfate; Bendroflumethiazide (Bendroflumethiazide)
Possible Naproxen side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-15
Patient: 69 year old male
Reactions: Haemoglobin Decreased, Gastrointestinal Haemorrhage, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-15
Patient: 72 year old female
Reactions: Haemoglobin Decreased, Duodenal Ulcer, Melaena, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Ramipril; Albuterol; Lactulose; Fostair; Bendroflumethiazide; Quinine Sulfate; Senna-Mint WAF
Possible Naproxen side effects in 65 year old male
Reported by a pharmacist from United States on 2012-06-06
Patient: 65 year old male, weighing 88.9 kg (195.6 pounds)
Reactions: Food Intolerance, Gastrointestinal Haemorrhage, Vomiting, Diarrhoea Haemorrhagic, Chest Pain, Condition Aggravated, Gastrooesophageal Reflux Disease, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in female
Reported by a physician from France on 2012-04-19
Patient: female, weighing 72.0 kg (158.4 pounds)
Reactions: Gastrointestinal Haemorrhage, Cardiac Failure, Coagulopathy, Atrial Fibrillation, Melaena, Haematemesis, Haemodynamic Instability
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: HIP Arthroplasty
Start date: 2010-11-15
End date: 2010-11-18
Naproxen
Dosage: 1100 mg
Administration route: Oral
Other drugs received by patient: Rabeprazole Sodium; Acetaminophen; Oxacillin; Allopurinol; Furosemide; Lexomil; Daflon; Aminophylline; Furadantin
Possible Naproxen side effects in female
Reported by a physician from France on 2012-04-05
Patient: female, weighing 72.0 kg (158.4 pounds)
Reactions: Gastrointestinal Haemorrhage, Cardiac Failure, Coagulopathy, Atrial Fibrillation, Melaena, Haematemesis, Haemodynamic Instability
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: HIP Arthroplasty
Start date: 2010-11-15
End date: 2010-11-18
Naproxen
Dosage: 1100 mg
Administration route: Oral
Other drugs received by patient: Daflon; Allopurinol; Aminophylline; Acetaminophen; Lexomil; Furosemide; Rabeprazole Sodium; Oxacillin; Furadantin
Possible Naproxen side effects in 78 year old female
Reported by a pharmacist from United States on 2012-02-21
Patient: 78 year old female
Reactions: Haemoglobin Decreased, Blood Urea Increased, Haematocrit Decreased, Melaena, Gastric Ulcer, Haematemesis, Occult Blood Positive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Possible Naproxen side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-21
Patient: 65 year old female
Reactions: Gastrointestinal Haemorrhage, Duodenal Ulcer, Gastric Ulcer, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: 250 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Ibuprofen
Dosage: 400 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Other drugs received by patient: Amlodipine; Acetaminophen and Codeine Phosphate; Bendrofluazide
Possible Naproxen side effects in
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-12-19
Patient:
Reactions: Gastrointestinal Haemorrhage, Duodenal Ulcer, Gastric Ulcer, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: 250 mg, tid
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Ibuprofen
Dosage: 400 mg, tid
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Other drugs received by patient: Amlodipine; Acetaminophen and Codeine Phosphate; Bendroflumethiazide
Possible Naproxen side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-12-16
Patient: 65 year old female
Reactions: Gastrointestinal Haemorrhage, Duodenal Ulcer, Gastric Ulcer, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: 400 mg;tid;po
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Naproxen
Dosage: 250 mg;tid;po
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Other drugs received by patient: CCO-Codamol; Bendroflumethiazide; Amlodipine
Possible Naproxen side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-09
Patient: 65 year old female
Reactions: Gastrointestinal Haemorrhage, Duodenal Ulcer, Gastric Ulcer, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: 400 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Naproxen
Dosage: 250 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Other drugs received by patient: Bendrofluazide; Amlodipine; Acetaminophen and Codeine Phosphate
Possible Naproxen side effects in
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-11-24
Patient:
Reactions: Gastrointestinal Haemorrhage, Duodenal Ulcer, Gastric Ulcer, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: 400 mg, tid
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Naproxen
Dosage: 250 mg, tid
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Other drugs received by patient: Acetaminophen and Codeine Phosphate; Bendroflumethiazide; Amlodipine
Possible Naproxen side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-21
Patient: 65 year old female
Reactions: Gastrointestinal Haemorrhage, Duodenal Ulcer, Gastric Ulcer, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Naproxen
Dosage: 250 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Ibuprofen
Dosage: 400 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Other drugs received by patient: Bendrofluazide; Acetaminophen and Codeine Phosphate; Amlodipine
Possible Naproxen side effects in
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-11-14
Patient:
Reactions: Gastrointestinal Haemorrhage, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: 400 mg, tid
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Naproxen
Dosage: 250 mg, tid
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Other drugs received by patient: Acetaminophen and Codeine Phosphate; Amlodipine; Bendroflumethiazide
Possible Naproxen side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-11
Patient: 65 year old female
Reactions: Gastrointestinal Haemorrhage, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: 400 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-26
End date: 2011-02-28
Naproxen
Dosage: 250 mg, 3x/day
Administration route: Oral
Indication: Sciatica
Start date: 2011-02-25
End date: 2011-02-28
Other drugs received by patient: Amlodipine; Bendrofluazide; Acetaminophen and Codeine Phosphate
Possible Naproxen side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-11-02
Patient: 69 year old female
Reactions: Haemoglobin Decreased, Malaise, Dizziness, Upper Gastrointestinal Haemorrhage, Gastric Ulcer, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fluoxetine HCL
Dosage: 20 mg, unk
Indication: Depression
Naproxen
Dosage: 500 mg, unk
Administration route: Oral
Indication: Arthralgia
Start date: 1997-12-24
End date: 2011-09-05
Other drugs received by patient: Acetaminophen and Codeine Phosphate; Tolterodine Tartrate; Levothyroxine Sodium; Imipramine
Possible Naproxen side effects in 69 year old female
Reported by a consumer/non-health professional from Israel on 2011-10-31
Patient: 69 year old female
Reactions: Haemoglobin Decreased, Malaise, Dizziness, Upper Gastrointestinal Haemorrhage, Gastric Ulcer, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fluoxetine HCL
Dosage: 20 mg, unk
Indication: Depression
Naproxen
Dosage: 500 mg, unk
Administration route: Oral
Indication: Arthralgia
Start date: 1997-12-24
End date: 2011-09-05
Other drugs received by patient: Acetaminophen and Codeine Phosphate; Levothyroxine Sodium; Tolterodine Tartrate; Imipramine
Possible Naproxen side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) on 2011-10-19
Patient: 69 year old female
Reactions: Haemoglobin Decreased, Malaise, Dizziness, Upper Gastrointestinal Haemorrhage, Gastric Ulcer, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fluoxetine
Dosage: (20 mg)
Indication: Depression
Naproxen
Dosage: (500 mg),oral
Administration route: Oral
Indication: Arthralgia
Start date: 1997-12-24
End date: 2011-09-05
Other drugs received by patient: Imipramine; Levothyroxine Sodium; Tolterodine Tartrate(tolterodine L-Tartrate); Acetaminophen W / Codeine
Possible Naproxen side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-11
Patient: 44 year old female, weighing 62.0 kg (136.4 pounds)
Reactions: Abdominal Pain Upper, Haematemesis
Drug(s) suspected as cause:
Naproxen
Other drugs received by patient: Omeprazole; Cephalexin; Acetaminophen and Codeine Phosphate; Domperidone; Tramadol HCL; Acetaminophen
Possible Naproxen side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2011-10-04
Patient: 69 year old female
Reactions: Haemoglobin Decreased, Malaise, Dizziness, Upper Gastrointestinal Haemorrhage, Gastric Ulcer, Haematemesis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fluoxetine
Dosage: 20 mg, unk
Indication: Depression
Naproxen
Dosage: 500 mg, unk
Administration route: Oral
Indication: Arthralgia
Start date: 1997-12-24
End date: 2011-09-05
Other drugs received by patient: Imipramine; Acetaminophen and Codeine Phosphate; Tolterodine Tartrate; Levothyroxine
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