"Jan. 13, 2011 - The FDA is warning about the dangers of acetaminophen in popular prescription pain drugs, but did it go far enough?
Acetaminophen, the active ingredient in Tylenol, is found in a wide range of over-the-counter and prescr"...
The most frequently reported adverse reactions are lightheadedness, dizziness, 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:
Central Nervous System
Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation.
Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Skin rash, pruritus.
Potential effects of high dosage are listed in the OVERDOSAGE section.
Drug Abuse And Dependence
Hydrocone bitartrate and acetaminophen tablets is classified as a Schedule II controlled substance.
Abuse And Dependence
Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; 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 narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic 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 Vicodin ES (hydrocodone bitartrate and acetaminophen) Side Effects Center for a complete guide to possible side effects
Patients receiving other narcotics, 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.
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Read the Vicodin ES Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/18/2016
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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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