Prescription medication · Opioid Analgesic Combination
acetaminophen/hydrocodone
Also sold as Vicodin, Norco, Lortab. This medicine can relieve minor aches and pains.
- 247,238
- FDA reports
- Rx
- Availability
acetaminophen/hydrocodone (Vicodin) is a prescription Opioid Analgesic Combination. This medicine can relieve minor aches and pains.
This medicine contains acetaminophen and hydrocodone. It is used to relieve moderate to severe pain.
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What it does
This medicine can relieve minor aches and pains.
Common side effects
Nausea, Headache, Dizziness
Key warnings
This drug has a risk of serious side effects, including addiction, abuse, and misuse, which can lead to overdose and death.
The sections below are summarized in plain English from acetaminophen/hydrocodone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Acetaminophen relieves pain and reduces fever. Hydrocodone is an opioid pain reliever. It works in the brain to decrease pain signals.
How to Take It
Adults and children 12 years and over should take 2 gelcaps every 6 hours as needed. Do not take more than 6 gelcaps in 24 hours, unless your doctor tells you to. Do not take it for more than 10 days unless your doctor tells you to. Children under 12 years should ask a doctor.
This is a plain-language summary of acetaminophen/hydrocodone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
This medicine may harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not recommended to breastfeed while taking this medicine, as it can pass into breast milk and cause serious harm to a nursing infant.
This is a plain-language summary of acetaminophen/hydrocodone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of acetaminophen/hydrocodone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, about 77°F. Avoid high humidity.
Side Effects (from patient reports)
Based on 247,238 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for acetaminophen/hydrocodone, by number of reports
- Tiredness
Tiredness
34,486 reports
- Feeling sick to your stomach
Feeling sick to your stomach
29,571 reports
- Head pain
Head pain
28,378 reports
- Aches
Aches
28,322 reports
- Loose stool
Loose stool
23,628 reports
- Difficulty breathing
Difficulty breathing
22,691 reports
- Joint pain
Joint pain
22,204 reports
- Throwing up
Throwing up
20,752 reports
- Fever
Fever
19,561 reports
- Skin irritation
Skin irritation
17,645 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Serious Warnings
This drug has a risk of serious side effects, including addiction, abuse, and misuse, which can lead to overdose and death. Your breathing may become dangerously slow. Do not take more medicine than prescribed. Never give this medicine to anyone else, especially children.
Common Questions
Can I take more than 6 gelcaps in 24 hours?
Can I take this medicine for more than 10 days?
Can children under 12 take this medicine?
What should I do if I miss a dose?
How should I store this medicine?
Can I drink alcohol while taking this medicine?
Is this medicine safe during pregnancy?
Can I breastfeed while taking this medicine?
What are the most common side effects?
What should I do if I experience serious side effects?
What are the common side effects of acetaminophen/hydrocodone?
What drug class is acetaminophen/hydrocodone?
Is acetaminophen/hydrocodone safe during pregnancy?
Related Medications in Opioid Analgesic Combination
Other drugs grouped near acetaminophen/hydrocodone - same-class peers and common alternatives.
abatacept
Orencia
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acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
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acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
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adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
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allopurinol
Zyloprim
Allopurinol is a medicine that lowers uric acid levels in your body.
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What the FDA Data Shows for acetaminophen/hydrocodone
The FDA label for acetaminophen/hydrocodone (sold under brand names such as Vicodin, Norco, Lortab) classifies it as a prescription-only medication in the Opioid Analgesic Combination class. This medicine can relieve minor aches and pains. Official labeling lists 3 commonly reported side effects, including Nausea, Headache, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 247,238 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 14, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages