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In addition to requiring new labeling on these prescript"...
Zydone Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zydone (hydrocodone bitartrate and acetaminophen) is a combination of a narcotic pain reliever (hydrocodone) and a less potent pain reliever that increases the effects of hydrocodone (acetaminophen) used to relieve moderate to severe pain. Common side effects include anxiety, dizziness, drowsiness, nausea, vomiting, upset stomach, constipation, headache, mood changes, blurred vision, ringing in your ears, or dry mouth.
The dosage of Zydone is adjusted according to severity of pain and response of the patient. Zydone may interact with other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, other medicines that can make you sleepy or slow your breathing, antidepressants, MAO inhibitors, atropine, benztropine, dimenhydrinate, glycopyrrolate, mepenzolate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, or irritable bowel medications. Tell your doctor all medications and supplements you use. It is unknown if this medication is harmful to a fetus, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Zydone (hydrocodone bitartrate and acetaminophen) 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.
Zydone 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, fear, 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 may include:
- anxiety, dizziness, drowsiness;
- mild nausea, vomiting, upset stomach, constipation;
- headache, mood changes;
- blurred vision;
- ringing in your ears; or
- dry mouth.
Read the entire detailed patient monograph for Zydone (Hydrocodone Bitartrate and Acetaminophen) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zydone FDA Prescribing Information: Side Effects
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Gastrointestinal System: Prolonged administration of ZYDONE (hydrocodone bitartrate and acetaminophen) (hydrocodone bitartrate and acetaminophen tablets) may produce constipation.
Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological: Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the OVERDOSAGE section.
Drug Abuse And Dependence
ZYDONE (hydrocodone bitartrate and acetaminophen) tablets are classified as a Schedule III controlled substance.
Abuse and Dependence
Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.
Read the entire FDA prescribing information for Zydone (Hydrocodone Bitartrate and Acetaminophen) »
Additional Zydone Information
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