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Endocet Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Endocet (oxycodone and acetaminophen) is a combination of a narcotic pain reliever and a non-narcotic pain reliever used to relieve moderate to moderately severe pain. Endocet is available in generic form. Common side effects of Endocet include nausea, vomiting, upset stomach, indigestion, constipation, lightheadedness, weakness, dizziness, drowsiness, itching or rash, blurred vision, dry mouth, or sweating.
Endocet is available in several different doses, adjusted according to the severity of the pain and the patient's response. Products that may interact with this drug include alcohol, pain medications, narcotics, allergy or cough and cold medications, seizure medications, medicine for sleep or anxiety, muscle relaxants, or psychiatric medications. Endocet contains acetaminophen, an ingredient in many nonprescription and combination prescription medications. Read labels or consult a pharmacist or doctor before taking Endocet with other pain relievers, fever reducers, or cold products to see if they contain acetaminophen as this can cause liver damage. During pregnancy, Endocet should be used only if a doctor prescribes it. Using it for long periods or in high doses near the expected delivery date is not recommended because of potential harm to the fetus. Babies born to mothers who have used this medication may have withdrawal symptoms. This medication passes into breast milk and may have effects on a nursing infant. Consult your doctor before breast-feeding. This medication may cause withdrawal reactions, especially if it has been used long-term or in high doses. Withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication.
Our Endocet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Endocet in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, unusual thoughts or behavior;
- seizure (convulsions);
- problems with urination; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects include:
- feeling dizzy or drowsy;
- mild nausea, vomiting, upset stomach, constipation;
- blurred vision; or
- dry mouth.
Read the entire detailed patient monograph for Endocet (Oxycodone and Acetaminophen Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Endocet FDA Prescribing Information: Side Effects
Serious adverse reactions that may be associated with ENDOCET (oxycodone and acetaminophen tablets) tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSAGE).
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.
Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.
Other adverse reactions obtained from postmarketing experiences with ENDOCET (oxycodone and acetaminophen tablets) tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:
Body as a Whole
Central and Peripheral Nervous System
Fluid and Electrolyte
Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus
Hearing and Vestibular
Hearing loss, tinnitus
Metabolic and Nutritional
Skin and Appendages
Drug Abuse And Dependence
ENDOCET (oxycodone and acetaminophen tablets) tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with chronic pain but may be more common in individuals who have a past history of alcohol or substance abuse or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.
Physical dependence on a prescribed medication does not signify addiction. Physical dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week period will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.
The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.
"Drug-seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor Shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated infection.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non- medical purposes, often in combination with other psychoactive substances. Oxycodone, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Like other opioid medications, ENDOCET (oxycodone and acetaminophen tablets) tablets are subject to the Federal Controlled Substances Act. After chronic use, ENDOCET (oxycodone and acetaminophen tablets) tablets should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.
Interactions with Alcohol and Drugs of Abuse
Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
Read the entire FDA prescribing information for Endocet (Oxycodone and Acetaminophen Tablets)
Additional Endocet Information
Report Problems to the Food and Drug Administration
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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