Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
The following adverse reactions have been identified during post approval use of Hydrocodone Bitartrate and Acetaminophen Tablet.
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 predominately 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.
Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a Schedule II controlled substance.
As an opioid, Hydrocodone Bitartrate and Acetaminophen Tablet exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Acetaminophen Tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Hydrocodone Bitartrate and Acetaminophen Tablets and reassess all patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets for the development of these behaviors or conditions.
Like all medications, Hydrocodone/apap can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: