Table 2.
Non-steroidal anti-inflammatory drugs and other drug classes associated with serious gastrointestinal events that resulted in life-threatening adverse events, caused patient hospitalization or prolonged hospitalization.
| Suspected Drugs | Number of Occurrences | Preferred Terms | Concomitant Drugs |
|---|---|---|---|
| Aceclofenac | 1 | Melaena, Duodenal ulcer, Gastric ulcer | Unknown |
| Acetylsalicylic acid + diclofenac b | 1 | Gastrointestinal hemorrhage | Unknown |
| Dabigatran etexilate + etoricoxib + amiodarone b | 1 | Melaena, Hematochezia | Furosemide + glyceryl trinitrate + tramadol and paracetamol a,b |
| Dexketoprofen | 1 | Vomiting | Paracetamol + tramadol + etoricoxib + pregabalin b |
| Diclofenac | 2 | Tongue oedema, Diarrhoea, Melaena, Gastric haemorrhage, Erosive oesophagitis | Unknown |
| Diclofenac + colchicine b | 1 | Diarrhea, Nausea, Dyspepsia, Vomiting, Abdominal pain upper | Salbutamol |
| Escitalopram + ibuprofen b | 1 | Gastric ulcer, Rectal injury, Abdominal pain, Decreased appetite, Rectal hemorrhage, Hematemesis | Metamizole + acetylsalicylic acid + sucralfate + pravastatin and fenofibrate a + citicoline + furosemide + etoricoxib + ferrous sulfate + midazolam + spironolactone b |
| Etoricoxib | 1 | Abdominal distension | Amiodarone + pantoprazole + diazepam + levomepromazine b |
| Ibuprofen + nimesulide b | 1 | Hematochezia | Omeprazole + alprazolam + pravastatin + amitriptyline + acetylsalicylic acid 100 mg + gabapentin + potassium clorazepate + metamizole b |
| Ibuprofen | 1 | Lip oedema | Unknown |
| Imidapril + ketoprofen b | 1 | Tongue oedema | Cobamamide + lansoprazole + atorvastatin + furosemide + finasteride + gliclazide + acetylsalicylic acid 100 mg + allopurinol + rilmenidine + idebenone b |
| Indomethacin | 1 | Gastrointestinal hemorrhage | Ibuprofen +clopidogrel b |
| Metformin and vildagliptin a + acemetacin b | 2 | Vomiting, Diarrhea | Simvastatin + furosemide +perindopril + amlodipine and indapamide a + sertraline + trazodone + codeine + lorazepam + omeprazole + magnesium + allopurinol b |
| Proglumetacin + metamizole b | 1 | Diarrhea, Nausea | Pregabalin |
| Ribavirin + sofosbuvir and ledipasvir a + ibuprofen b | 1 | Duodenal ulcer hemorrhage | Unknown |
a Fixed combination of drugs (patient taking only a medication). b Combinations of two or more different medications (patient taking different medication each one containing a chemical substance).