ADVERSE REACTIONS
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:
Central Nervous System
Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.
Gastrointestinal System
Prolonged administration of ZYDONE (hydrocodone bitartrate and acetaminophen tablets) may produce constipation.
Genitourinary System
Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Respiratory Depression
Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on brain stem respiratory center (see OVERDOSAGE).
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.
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