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Paracetamol+codeine Side Effects

Common Paracetamol+codeine Side Effects


The most commonly reported Paracetamol+codeine side effects (click to view or check a box to report):

Pancreatitis Acute (5)
Alanine Aminotransferase Increased (2)
Abdominal Pain Upper (2)
Aspartate Aminotransferase Increased (2)
Suicide Attempt (2)
Apnoea (1)
Aortic Aneurysm Rupture (1)
Respiratory Disorder (1)
Mechanical Ventilation (1)
Miosis (1)
Pancreatitis (1)
Prothrombin Time Prolonged (1)
Myocardial Ischaemia (1)
Overdose (1)
Cerebral Infarction (1)
Oesophagitis (1)
Obstructive Airways Disorder (1)
Completed Suicide (1)
Metabolic Disorder (1)
Cerebrovascular Accident (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Paracetamol+codeine Side Effects Reported to FDA

The following Paracetamol+codeine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Paracetamol+codeine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Abdominal Pain Upper
This is a report of a 50-year-old male patient (weight: NA) from UNITED KINGDOM, suffering from the following symptoms/conditions: osteoarthritis, who was treated with Paracetamol+codeine (ngx) (dosage: 1 Df, Unk, start time: Jan 28, 2010), combined with:
  • Simvastatin (40 Mg, Unk)
  • Omeprazole (40 Mg, Unk)
  • Acidex (Unk)
  • Aspirin (75 Mg, Unk)
  • Metformin Hcl (1.5 G, Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Abdominal Pain Upper
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paracetamol+codeine (ngx) treatment in male patients, resulting in abdominal pain upper side effect. The patient was hospitalized.

Abdominal Pain Upper
This report suggests a potential Paracetamol+codeine (ngx) Abdominal Pain Upper side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from UNITED KINGDOM was diagnosed with the following symptoms/conditions: osteoarthritis and used Paracetamol+codeine (ngx) (dosage: 1 Df, Unk) starting Jan 28, 2010. Soon after starting Paracetamol+codeine (ngx) the patient began experiencing various side effects, including:
  • Abdominal Pain Upper
Drugs used concurrently:
  • Simvastatin (40 Mg, Unk)
  • Acidex (Unk)
  • Acetylsalicylic Acid (75 Mg, Unk)
  • Omeprazole (40 Mg, Unk)
  • Metformin Hcl (1.5 G, Unk)
The patient was hospitalized. Although Paracetamol+codeine (ngx) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as abdominal pain upper, may still occur.

Areflexia, Cerebrovascular Accident, Hemiparesis, Loss Of Consciousness, Mechanical Ventilation, Obstructive Airways Disorder, Overdose, Respiratory Disorder, Suicide Attempt
This Areflexia, Cerebrovascular Accident, Hemiparesis, Loss Of Consciousness, Mechanical Ventilation, Obstructive Airways Disorder, Overdose, Respiratory Disorder, Suicide Attempt problem was reported by a physician from UNITED KINGDOM. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Paracetamol+codeine (ngx) (dosage: NA). The following drugs were being taken at the same time:
  • Diazepam
  • Chloral Hydrate
  • Alcohol
  • Methotrexate (ngx)
When commencing Paracetamol+codeine (ngx), the patient experienced the following unwanted symptoms/side effects:
  • Areflexia
  • Cerebrovascular Accident
  • Hemiparesis
  • Loss Of Consciousness
  • Mechanical Ventilation
  • Obstructive Airways Disorder
  • Overdose
  • Respiratory Disorder
  • Suicide Attempt
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as areflexia, may become evident only after a product is in use by the general population.

Apnoea, Cerebral Infarction, Metabolic Disorder, Miosis, Unresponsive To Stimuli
This is a report of a male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: analgesia and was treated with 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) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Apnoea
  • Cerebral Infarction
  • Metabolic Disorder
  • Miosis
  • Unresponsive To Stimuli
The patient was hospitalized. This opens a possibility that Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha treatment could cause the above reactions, including apnoea, and some male subjects may be more susceptible.


Pancreatitis Acute
A 24-year-old male patient (weight: NA) from FRANCE with the following symptoms/conditions: headache started Paracetamol+codeine (ngx)(acetaminophen (paracetamol),codeine Phosphat treatment (dosage: Single Dose: 500mg/20mg, Oral) on NS. Soon after starting Paracetamol+codeine (ngx)(acetaminophen (paracetamol),codeine Phosphat treatment, the subject experienced various side effects, including:
  • Pancreatitis Acute
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Paracetamol+codeine (ngx)(acetaminophen (paracetamol),codeine Phosphat.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Hiatus Hernia, Oesophagitis, Pancreatitis Acute
A 60-year-old male patient from SPAIN (weight: NA) experienced symptoms, such as: nasopharyngitis and was treated with Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph(dosage: Oral). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
  • Blood Bilirubin Increased
  • Hiatus Hernia
  • Oesophagitis
  • Pancreatitis Acute
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph efficacy: NA.The patient was hospitalized.

Pancreatitis Acute
In this report, Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosth was administered for the following condition: headache.A 24-year-old male consumer from FRANCE (weight: NA) started Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosth treatment (dosage: Single Dose: 500mg/20mg, Oral) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pancreatitis Acute
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosth treatment could be related to the listed above side effect(s).

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pancreatitis Acute
This is a report of the following Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha side effect(s):
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
  • Pancreatitis Acute
A 60-year-old male patient from SPAIN (weight: NA) presented with the following condition: nasopharyngitis and received a treatment with Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha (dosage: Oral) starting: NS.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha treatment could be associated with the listed above side effect(s).

Pancreatitis
This Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha report was submitted by a 35-year-old male consumer from UNITED KINGDOM (weight: NA). The patient was diagnosed with: NA and Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha was administered (dosage: 10-20 Tds, Oral) starting: NS. The consumer developed a set of symptoms:
  • Pancreatitis
Other drugs used simultaneously:
  • Zopiclone(zopiclone) (10-20 Tds, Oral)
The patient was hospitalized.Those unexpected symptoms could be linked to a Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Left Ventricular Failure, Myocardial Ischaemia
This is a report of a possible correlation between Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha use and the following symptoms/side effect(s):
  • Left Ventricular Failure
  • Myocardial Ischaemia
which could contribute to an assessment of Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha risk profile.A 78-year-old male consumer from (weight: NA) was suffering from NA and was treated with Paracetamol+codeine (ngx)(acetaminophen (paracetamol), Codeine Phospha (dosage: NA) starting NS.Other concurrent medications:
  • 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
A 82-year-old female patient from (weight: NA) presented with the following symptoms: NA and after a treatment with Paracetamol+codeine Phosphate (ngx) (acetaminophen (paracetamol), Code (dosage: NA) experienced the following side effect(s):
  • Aortic Aneurysm Rupture
  • Completed Suicide
  • Hepatic Enzyme Increased
  • Intentional Misuse
  • Prothrombin Time Prolonged
  • Suicide Attempt
The treatment was started on NS. Paracetamol+codeine Phosphate (ngx) (acetaminophen (paracetamol), Code was used in combination with the following drugs:
  • Furosemide+amiloride Hydrochloride (ngx) (amiloride, Furosemide)
  • Acetylsalicylic Acid (ngx) (acetylsalicylic Acid)
  • Calcichew-d3 (calcium Carbonate, Colecalciferol)
  • Ibuprofen
The patient was hospitalized.This report could alert potential Paracetamol+codeine Phosphate (ngx) (acetaminophen (paracetamol), Code consumers.

Pancreatitis Acute
In this report, a 24-year-old male patient from (weight: NA) was affected by a possible Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph side effect.The patient was diagnosed with headache. After a treatment with Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph (dosage: See Image, start date: NS), the patient experienced the following side effect(s):
  • Pancreatitis Acute
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Paracetamol+codeine (ngx) (acetaminophen (paracetamol), Codeine Phosph treatment.



Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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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    Paracetamol+codeine Safety Alerts, Active Ingredients, Usage Information

    More About Paracetamol+codeine

    Side Effects reported to FDA: 12

    Paracetamol+codeine safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 3

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