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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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