Hydrocodone 5/500mg – Uses, Safety, Side Effects & Important Information

Hydrocodone 5/500mg is a historical hydrocodone/acetaminophen combination containing 5 mg of hydrocodone bitartrate and 500 mg of acetaminophen per tablet. Historical U.S. drug labeling documents this formulation, but its regulatory status should be distinguished from currently approved hydrocodone/acetaminophen products.

The Hydrocodone 5/500mg product page at PrimeFitt identifies the product as containing 5 mg hydrocodone and 500 mg acetaminophen. The page itself should not be interpreted as independent FDA approval or as verification of the product's current regulatory status.

What Is Hydrocodone 5/500mg?

Hydrocodone 5/500mg historically contained two active ingredients:

• Hydrocodone bitartrate – 5 mg: an opioid analgesic.

• Acetaminophen – 500 mg: a non-opioid pain reliever and fever reducer.

Historical FDA/DailyMed documentation confirms that hydrocodone/acetaminophen products were available in formulations containing hydrocodone and varying amounts of acetaminophen.

Hydrocodone acts on opioid receptors in the central nervous system to alter the perception and response to pain, while acetaminophen contributes additional analgesic activity.

For product-specific information, see the PrimeFitt Hydrocodone 5/500mg page.

What Is Hydrocodone 5/500mg Used For?

Historically, hydrocodone/acetaminophen combination products were prescribed for pain sufficiently severe to require an opioid analgesic.

Depending on the clinical situation, hydrocodone combination therapy could be considered for:

• Acute moderate-to-severe pain

• Certain injury-related pain

• Pain following medical or surgical procedures

• Other painful conditions where an opioid was considered appropriate

The decision to use an opioid depends on the patient's diagnosis, severity of pain, previous treatments, medical history, and individual risk factors.

Because Hydrocodone 5/500mg represents an older formulation, patients should not rely on historical prescribing information as current treatment advice.

How Does Hydrocodone 5/500mg Work?

Hydrocodone is a semisynthetic opioid analgesic. It acts primarily through opioid receptors in the central nervous system, reducing the perception and response to painful stimuli.

Acetaminophen works through a separate analgesic mechanism and adds non-opioid pain-relieving activity.

The combination was designed to provide analgesia through two active ingredients.

Hydrocodone 5/500mg Dosage Information

Hydrocodone is a potent prescription opioid, so dosage should be determined by the prescribing healthcare professional.

Historical dosing instructions for older 5/500mg formulations should not be used as current self-treatment instructions. Current treatment should be based on the exact medication dispensed, its approved labeling, the patient's medical condition, and the prescriber's instructions.

Patients should:

• Take hydrocodone only as prescribed.

• Never increase the amount without medical advice.

• Avoid taking additional acetaminophen unless a healthcare professional confirms that it is appropriate.

• Never share opioid medication.

• Tell their healthcare professional about all other medicines and supplements they use.

Hydrocodone 5/500mg Side Effects

Hydrocodone/acetaminophen may cause side effects such as:

• Drowsiness

• Dizziness

• Nausea

• Vomiting

• Constipation

• Lightheadedness

• Sedation

• Fatigue

More serious opioid-related reactions can include:

• Slow or difficult breathing

• Severe sedation

• Loss of consciousness

• Respiratory depression

• Dependence

• Misuse

• Overdose

FDA-approved hydrocodone labeling carries significant warnings concerning respiratory depression, misuse, addiction, and potentially fatal opioid-related complications.

Acetaminophen and Liver Safety

The 500 mg acetaminophen component is particularly important when discussing this historical formulation.

Excessive acetaminophen exposure can cause severe liver injury. The risk can increase when a person takes multiple medicines containing acetaminophen.

FDA specifically requested that manufacturers limit the amount of acetaminophen in prescription combination products to 325 mg per dosage unit because higher amounts could increase the risk of serious liver injury.

Patients should check other prescription and over-the-counter medicines for:

• Acetaminophen

• APAP

• Paracetamol

before combining them with a hydrocodone/acetaminophen product.

For official regulatory information, see the FDA drug safety information and FDA-approved hydrocodone labeling.

Hydrocodone 5/500mg vs. Hydrocodone 5/325mg

The main difference is the amount of acetaminophen:

Formulation	Hydrocodone	Acetaminophen
Hydrocodone 5/500mg	5 mg	500 mg
Hydrocodone 5/325mg	5 mg	325 mg

FDA documentation confirms an approved 5 mg/325 mg hydrocodone/acetaminophen formulation.

The 5/500mg formulation is an older formulation and should not automatically be considered interchangeable with a currently approved 5/325mg product.

Is Hydrocodone 5/500mg FDA Approved?

This point requires careful wording.

Historical hydrocodone/acetaminophen products containing 500 mg acetaminophen were documented in U.S. labeling. However, FDA later took regulatory action concerning prescription combination products containing more than 325 mg acetaminophen per dosage unit because of the risk of severe liver injury. FDA stated in a 2017 enforcement action that there were no approved drug applications in effect for the 500 mg-acetaminophen hydrocodone products being marketed on the websites involved in that action.

Therefore, a product page should not claim that Hydrocodone 5/500mg is currently FDA-approved simply because historical FDA or DailyMed records document the formulation.

Current FDA-approved hydrocodone/acetaminophen products include formulations containing 325 mg acetaminophen, such as hydrocodone 5 mg/325 mg.

Alcohol and Hydrocodone

Alcohol can increase opioid-related sedation and respiratory-depression risks.

Patients using hydrocodone should discuss alcohol consumption with their healthcare professional and generally avoid combining alcohol with opioid medication unless specifically instructed otherwise.

Hydrocodone and Other Medicines

Tell the prescribing healthcare professional about all prescription medicines, OTC products, supplements, and other substances being used.

Particular caution is required with:

• Benzodiazepines

• Other opioids

• Sedative medications

• Sleep medicines

• Alcohol

• Other central nervous system depressants

Combining opioids with benzodiazepines or other CNS depressants can increase the risk of profound sedation and respiratory depression. FDA-approved hydrocodone labeling contains warnings regarding these combinations.

Dependence, Misuse and Withdrawal

Hydrocodone can cause physical dependence, tolerance, and addiction.

Physical dependence means the body adapts to repeated exposure, while addiction involves compulsive drug use despite harmful consequences. These are not identical conditions.

Patients taking opioids regularly should not abruptly discontinue treatment without discussing an appropriate plan with their healthcare professional.

Hydrocodone 5/500mg and Driving

Hydrocodone may cause:

• Drowsiness

• Dizziness

• Slower reaction time

• Impaired coordination

• Reduced alertness

Patients should avoid driving or operating machinery until they know how the medication affects them.

Alcohol and other sedating medicines can further increase impairment.

What Happens in a Hydrocodone Overdose?

An opioid overdose can be life-threatening.

Warning signs can include:

• Extremely slow or shallow breathing

• Difficulty breathing

• Extreme sleepiness

• Inability to wake

• Loss of consciousness

• Bluish or grayish lips or skin

Because the medication also contains acetaminophen, excessive exposure can additionally cause serious liver injury.

Suspected opioid overdose requires immediate emergency medical attention. Naloxone can reverse opioid effects and may be used as an emergency rescue medication when appropriate.

Safe Storage and Disposal

Hydrocodone should be stored securely and kept away from children and anyone for whom it was not prescribed.

Unused opioid medication should be disposed of through an authorized medication take-back or disposal program whenever possible.

Safe storage and disposal can help reduce accidental exposure, misuse, and diversion.

Frequently Asked Questions

What does Hydrocodone 5/500mg contain?

Historical Hydrocodone 5/500mg tablets contained 5 mg hydrocodone bitartrate and 500 mg acetaminophen per tablet.

Is Hydrocodone 5/500mg the same as Hydrocodone 5/325mg?

No. Both contain 5 mg hydrocodone, but the acetaminophen amounts differ. The 5/500mg formulation contains 500 mg acetaminophen, while the FDA-approved 5/325mg formulation contains 325 mg.

Why was the acetaminophen amount reduced?

FDA requested that manufacturers limit prescription combination products to 325 mg acetaminophen per dosage unit because of concerns about severe liver injury.

Can Hydrocodone 5/500mg cause dependence?

Yes. Hydrocodone is an opioid and can cause physical dependence, tolerance, misuse, and addiction.

Can alcohol be taken with hydrocodone?

Alcohol can increase sedation and respiratory-depression risks associated with opioids. Patients should discuss alcohol use with their healthcare professional.

Can additional acetaminophen be taken with Hydrocodone 5/500mg?

Additional acetaminophen can increase total acetaminophen exposure and potentially increase liver-injury risk. Ask a doctor or pharmacist before combining acetaminophen-containing medicines.

Important Safety Information

Hydrocodone is a prescription opioid and should only be used under appropriate medical supervision.

The 5/500mg formulation should not be presented as a currently FDA-approved formulation merely because historical labeling exists. FDA-approved hydrocodone/acetaminophen products with 325 mg acetaminophen are documented in FDA labeling, while FDA has taken action concerning prescription hydrocodone products containing 500 mg acetaminophen.

For authoritative information, consult FDA, FDA AccessData, and DailyMed.