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Pregnancy and breastfeeding

Pregnancy category C: Risk in pregnancy cannot be ruled out. Animal controlled studies have not been conducted with this medication.[8]

Low concentrations of acetaminophen is excreted through breast milk, however, hydrocodone’s excretion is unknown.[8]

Kidney and liver impairment

Use with caution due to possible risk of toxicity.[8]

Side effects

Most common
  • Lightheadedness[3]
  • Dizziness[3]
  • Euphoria[citation needed]
  • Sedation[3]
  • Nausea and vomiting[3]
  • Headaches
Less common
  • Central nervous system: drowsiness, confusion, lethargy, anxiety, fear, unease, psychic dependence, mood changes, impairment of mental and physical performance[3]
  • Gastrointestinal system: constipation[3]
  • Genitourinary system: inability to urinate, bladder spasms[3]
  • Respiratory depression: inadequate breaths[3]
  • Special senses: hearing impairment, permanent hearing loss[3]
  • Dermatological: rash, itching[3]

* Exact prevalence (%) is unknown[citation needed]

Black box warning

“Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.”[3]

Allergy warning

“Do not take hydrocodone bitartrate and acetaminophen tablets if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking hydrocodone bitartrate and acetaminophen tablets and contact your healthcare provider immediately.”[3]


Hydrocodone: Respiratory depression, extreme somnolence progressing towards coma, muscle limpness, cold and clammy skin, slow heart rate, low blood pressure, abrupt loss of heart function, and death may occur.[3] visit more

Acetaminophen: Liver and kidney failure, low blood sugar coma may occur.[3]


  • Mechanism of action: Hydrocodone acts primarily at the mu-opioid receptors, but is also a weak agonist against the delta opioid and kappa opioid receptors.[10]
  • Absorption/distribution: The oral formulation can be absorbed from the gastrointestinal tract and remain 20-50% bound to plasma proteins.[10] The onset of analgesia is about 20 to 30 minutes with duration of 4 to 8 hours and t1/2 of 3 to 4 hours.[10]
  • Metabolism/excretion: It is metabolized to norhydrocodone by cytochrome P450 3A4 and to hydromorphone, also biologically active, by cytochrome P450 2D6.[11][12] For individuals who have a defect in the gene encoding CYP2D6, the clearance of the drug will be lower and less metabolite such as hydromorphone will be formed; however, the effect on analgesia remains unknown.[12]
  • Mechanism of action: Acetaminophen acts to inhibit COX enzyme, which is responsible for prostaglandin synthesis.[13] Prostaglandins increase the perception of pain. Inhibition of prostaglandin production helps to alleviate pain.[14] visit more
  • Absorption/distribution: The half-life of oral acetaminophen is 1.25 to 3 hours and peak level is reached by 10–60 minutes after ingestion.[15]
  • Metabolism/excretion: Acetaminophen is metabolized primarily in the liver via glucuronidation and sulfation to mostly non-toxic metabolites and some highly reactive metabolites, which is inactivated by glutathione.[15] 85% of the oral dose is excreted renally.[3] At high doses, the supply of glutathione cannot meet its demand, thus results in the accumulation of highly reactive compounds leading to liver damage.[15]
Brand names READ MORE

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