Get emergency medical help if you have signs of an allergic reaction: hives, rash; fever, difficulty breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- weak or shallow breathing, breathing that stops during sleep;
- severe constipation;
- confusion, unusual thoughts or behavior, feeling like you might pass out;
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, feeling weak or tired.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects may include:
- stomach pain, nausea, vomiting, constipation;
- headache, dizziness, drowsiness, tiredness;
- rash; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Endodan (Oxycodone and Aspirin Tablets)
Serious adverse reactions that may be associated with ENDODAN tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSE).
The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation and pruritus.
Aspirin may increase the likelihood of hemorrhage due to its effect on the gastric mucosa and platelet function. Furthermore, aspirin has the potential to cause anaphylaxis in hypersensitive patients as well as angioedema especially in patients with chronic urticaria. Other adverse reactions due to aspirin use include anorexia, reversible hepatotoxicity, leukopenia, thrombocytopenia, purpura, decreased plasma iron concentration, and shortened erythrocyte survival time.
Other adverse reactions obtained from postmarketing experiences with ENDODAN tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:
Body As A Whole
allergic reaction, malaise, asthenia, headache, anaphylaxis, fever, hypothermia, thirst, increased sweating, accident, accidental overdose, non-accidental overdose.
tachycardia, dysrhythmias, hypotension, orthostatic hypotension, bradycardia, palpitations
Central And Peripheral Nervous System
stupor, paresthesia, agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures, anxiety, mental impairment
Fluid And Electrolyte
dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis
hemorrhagic gastric/duodenal ulcer, gastric/peptic ulcer, dyspepsia, abdominal pain, diarrhea, eructation, dry mouth, gastrointestinal bleeding, intestinal perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye syndrome, pancreatitis, intestinal obstruction, ileus
Hearing And Vestibular
hearing loss, tinnitus. Patients with high frequency loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism.
unspecified hemorrhage, purpura, reticulocytosis, prolongation of prothrombin time, disseminated intravascular coagulation, ecchymosis, thrombocytopenia.
acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction
Metabolic And Nutritional
hypoglycemia, hyperglycemia, acidosis, alkalosis
miosis, visual disturbances, red eye.
drug dependence, drug abuse, somnolence, depression, nervousness, hallucination
prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding, closure of patent ductus arteriosis
bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema
Skin And Appendages
urticaria, rash, flushing
interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention
Read the entire FDA prescribing information for Endodan (Oxycodone and Aspirin Tablets)
© Endodan Patient Information is supplied by Cerner Multum, Inc. and Endodan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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