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For Healthcare Professionals
Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet

General
The most commonly reported adverse reactions include light-headedness, dizziness, sedation, nausea and vomiting.[Ref]

Nervous system
Hydrocodone-acetaminophen:

Frequency not reported: Dizziness, lightheadedness, mental and physical performance impairment, lethargy, sedation, somnolence progressing to stupor or coma

Opioids:

Frequency not reported: Serotonin syndrome[Ref]



Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Cardiovascular
Frequency not reported: Bradycardia, cardiac arrest, circulatory collapse, hypotension

Hepatic
Frequency not reported: Hepatic necrosis, hepatitis[Ref]

Gastrointestinal
Frequency not reported: Abdominal pain, constipation, gastric distress, heartburn, nausea, peptic ulcer, vomiting, occult blood loss[Ref]

Dermatologic
Frequency not reported: Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions, cold and clammy skin, diaphoresis[Ref]

Renal
Frequency not reported: Renal toxicity, renal tubular necrosis[Ref]

Hematologic
Frequency not reported: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia[Ref]

Hypersensitivity
Frequency not reported: Allergic reactions, anaphylaxis[Ref]

Respiratory
Frequency not reported: Acute airway obstruction, apnea, dose-related respiratory depression, shortness of breath[Ref]

Metabolic
Frequency not reported: Hypoglycemic coma

Genitourinary
Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention[Ref]

Endocrine
Opioids:

Frequency not reported: Androgen deficiency, adrenal insufficiency

Other
Frequency not reported: Hearing impairment or permanent loss[Ref]

Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.[Ref]

Musculoskeletal
Frequency not reported: Skeletal muscle flaccidity

Psychiatric
Frequency not reported: Anxiety, euphoria, fear, mood changes, psychological dependence, dysphoria
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