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Paracetamol+codeine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Abdominal Pain Upper (6748984-0)
on May 17, 2010 Male from UNITED KINGDOM , 50 years of age, was diagnosed with
  • osteoarthritis
and was treated with Paracetamol+codeine (ngx). Directly after, patient experienced the unwanted or unexpected Paracetamol+codeine side effects: abdominal pain upper. Paracetamol+codeine (ngx) dosage: 1 Df, Unk.
Associated medications used:
  • Simvastatin (40 Mg, Unk)
  • Omeprazole (40 Mg, Unk)
  • Acidex (Unk)
  • Aspirin (75 Mg, Unk)
  • Metformin Hcl (1.5 G, Unk)
Patient was hospitalized.

Abdominal Pain Upper (6739441-6)
Patient was taking Paracetamol+codeine (ngx). Patient felt the following Paracetamol+codeine side effects: abdominal pain upper on May 17, 2010 from UNITED KINGDOM Additional patient health information: Male , 50 years of age, was diagnosed with
  • osteoarthritis
and. Paracetamol+codeine (ngx) dosage: 1 Df, Unk.
Multiple prescriptions taken:
  • Simvastatin (40 Mg, Unk)
  • Acidex (Unk)
  • Acetylsalicylic Acid (75 Mg, Unk)
  • Omeprazole (40 Mg, Unk)
  • Metformin Hcl (1.5 G, Unk)
Patient was hospitalized.

Areflexia, Cerebrovascular Accident, Hemiparesis, Loss Of Consciousness, Mechanical Ventilation, Obstructive Airways Disorder, Overdose, Respiratory Disorder, Suicide Attempt (6547172-0)
Adverse event was reported on Jan 13, 2010 by a Female taking Paracetamol+codeine (ngx) (Dosage: N/A) . Location: UNITED KINGDOM , 62 years of age, After Paracetamol+codeine was administered, patient encountered several Paracetamol+codeine side effects: areflexia, cerebrovascular accident, hemiparesis, loss of consciousness, mechanical ventilation, obstructive airways disorder, overdose, respiratory disorder, suicide attempt.
Multiple concurrent drugs taken:
  • Diazepam
  • Chloral Hydrate
  • Alcohol
  • Methotrexate (ngx)
Patient was hospitalized.

Apnoea, Cerebral Infarction, Metabolic Disorder, Miosis, Unresponsive To Stimuli (5391258-3)
on Jul 03, 2007 Male from UNITED STATES , weighting 30.20 lb, was diagnosed with
  • analgesia
and was treated with Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha. Directly after, patient experienced the unwanted or unexpected Paracetamol+codeine side effects: apnoea, cerebral infarction, metabolic disorder, miosis, unresponsive to stimuli. Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha dosage: 1.75 Mg/kg/dose; 2 Single Doses During 5 Hrs; 12-24 Mg/dose, 4/times Day; 1.75 Mg/kg, Once/single. Patient was hospitalized.


Pancreatitis Acute (5200977-0)
on Dec 18, 2006 Male from FRANCE , 24 years of age, was diagnosed with
  • headache
and was treated with Paracetamol+codeine (ngx)(acetaminophen (paracetamol),codeine Phosphat. Patient felt the following Paracetamol+codeine side effects: pancreatitis acute. Paracetamol+codeine (ngx)(acetaminophen (paracetamol),codeine Phosphat dosage: Single Dose: 500mg/20mg, Oral. Patient was hospitalized.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Hiatus Hernia, Oesophagitis, Pancreatitis Acute (5191207-7)
Patient was taking Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph. After Paracetamol+codeine was administered, patient encountered several Paracetamol+codeine side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, hiatus hernia, oesophagitis, pancreatitis acute on Dec 04, 2006 from SPAIN Additional patient health information: Male , 60 years of age, was diagnosed with
  • nasopharyngitis
and. Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph dosage: Oral. Patient was hospitalized.

Pancreatitis Acute (5189912-1)
Adverse event was reported on Dec 08, 2006 by a Male taking Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosth (Dosage: Single Dose: 500mg/20mg, Oral) was diagnosed with
  • headache
and. Location: FRANCE , 24 years of age, Directly after, patient experienced the unwanted or unexpected Paracetamol+codeine side effects: pancreatitis acute. Patient was hospitalized.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pancreatitis Acute (5170302-2)
on Nov 24, 2006 Male from SPAIN , 60 years of age, was diagnosed with
  • nasopharyngitis
and was treated with Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha. Patient felt the following Paracetamol+codeine side effects: alanine aminotransferase increased, aspartate aminotransferase increased, pancreatitis acute. Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha dosage: Oral. Patient was hospitalized.

Pancreatitis (4920317-1)
on Feb 06, 2006 Male from UNITED KINGDOM , 35 years of age, was treated with Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha. After Paracetamol+codeine was administered, patient encountered several Paracetamol+codeine side effects: pancreatitis. Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha dosage: 10-20 Tds, Oral.
Multiple concurrent drugs taken:
  • Zopiclone(zopiclone) (10-20 Tds, Oral)
Patient was hospitalized.

Left Ventricular Failure, Myocardial Ischaemia (4681142-2)
Patient was taking Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha. Directly after, patient experienced the unwanted or unexpected Paracetamol+codeine side effects: left ventricular failure, myocardial ischaemia on May 23, 2005 from Additional patient health information: Male , 78 years of age, . Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha dosage: N/A.
Associated medications used:
  • Simvastatin
  • Furosemide
  • Acetylsalicylic Acid (ngx) (acetylsalicylic Acid)
  • Salbutamol (ngx) (salbutamol)
  • Isorbide Mononitrate (isosorbide Mononitrate)
  • Bisoprolol (ngx) (bisoprolol)
  • Spiriva
  • Nicorandil (nicorandil)


Aortic Aneurysm Rupture, Completed Suicide, Hepatic Enzyme Increased, Intentional Misuse, Prothrombin Time Prolonged, Suicide Attempt (4554467-9)
Adverse event was reported on Oct 23, 2003 by a Female taking Paracetamol+codeine Phosphate (ngx) (acetaminophen (paracetamol), Code (Dosage: N/A) . Location: , 82 years of age, Patient felt the following Paracetamol+codeine side effects: aortic aneurysm rupture, completed suicide, hepatic enzyme increased, intentional misuse, prothrombin time prolonged, suicide attempt.
Multiple prescriptions taken:
  • Furosemide+amiloride Hydrochloride (ngx) (amiloride, Furosemide)
  • Acetylsalicylic Acid (ngx) (acetylsalicylic Acid)
  • Calcichew-d3 (calcium Carbonate, Colecalciferol)
  • Ibuprofen
Patient was hospitalized.

Pancreatitis Acute (4554464-3)
on Oct 07, 2004 Male from , 24 years of age, was diagnosed with
  • headache
and was treated with Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph. After Paracetamol+codeine was administered, patient encountered several Paracetamol+codeine side effects: pancreatitis acute. Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph dosage: See Image. Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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