NORCO SIDE EFFECTS

SIDE EFFECTS

The following adverse reactions have been identified during post approval use of NORCO. 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, dizziness, sedation, nausea and vomiting. Other adverse reactions include:

Central Nervous System – Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, 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 predominantly in patients with chronic overdose.

Dermatological – Skin rash, pruritus, Stevens-Johnson syndrome, 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 NORCO.
• Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.