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VICODIN, VICODIN ES, VICODIN HP (HYDROCODONE/ACETAMINOPHEN) TABLETS: ADVERSE REACTIONS / SIDE EFFECTS
The following adverse reactions have been identified during post approval use of Vicodin (Hydrocodone Bitartrate, Acetaminophen) tablets. Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequently reported adverse reactions are dizziness, light-headedness, sedation, nausea and vomiting.
Other adverse reactions include:
Central Nervous System: drowsiness, lethargy, mental clouding, impairment of mental and physical performance, fear, anxiety, dysphoria, psychological dependence, mood changes.
Gastrointestinal System: constipation.
Genitourinary System: ureteral spasm, spasm of vesical sphincters, and urinary retention.
Special Senses: cases of hearing impairment or permanent loss have been reported predominately in patients with chronic overdose.
Dermatological: skin rash, Stevens-Johnson syndrome, pruritus, toxic epidermal necrolysis, allergic reactions.
Hematological: thrombocytopenia, agranulocytosis.
Serotonin syndrome: cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Vicodin, Vicodin ES, Vicodin HP.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.
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