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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 Zydone (hydrocodone bitartrate and acetaminophen) Side Effects Center for a complete guide to possible side effects »
Patients receiving opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Zydone 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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