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NORCO (HYDROCODONE/ACETAMINOPHEN) TABLETS: ADVERSE REACTIONS / SIDE EFFECTS

The following adverse reactions have been identified during post approval use of Norco (Hydrocodone, Acetaminophen). 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 light-headedness, sedation, dizziness, nausea and vomiting.

Other adverse reactions include:

Central Nervous System: mental clouding, drowsiness, lethargy, impairment of mental and physical performance, fear, anxiety, dysphoria, mood changes, psychological dependence.

Gastrointestinal System: constipation.

Genitourinary System: spasm of vesical sphincters, ureteral spasm, urinary retention.

Special Senses: cases of hearing impairment or permanent loss have been reported predominately in patients with chronic overdose.

Dermatological: pruritus, skin rash, Stevens-Johnson syndrome, allergic reactions, toxic epidermal necrolysis.

Hematological: agranulocytosis, thrombocytopenia.

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 Norco (Hydrocodone, Paracetamol).
  • Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.

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