Oxycodone Hydrochloride
Oxycodone hydrochloride · Say it: ox-ee-KOE-done hye-dro-KLOR-ide
A strong prescription opioid pain medicine taken by mouth for severe pain when other treatments are not enough or cannot be tolerated.
⬛ Boxed warning (the FDA's strongest warning)
The label carries a boxed warning about serious and life-threatening risks. (1) Addiction, abuse, and misuse: use can expose people to opioid addiction, abuse, and misuse, which can lead to overdose and death. Prescribers are asked to assess each person's risk before prescribing and reassess regularly. (2) Life-threatening breathing problems: serious, life-threatening, or fatal respiratory depression (slowed or stopped breathing) may occur, especially when starting or after a dose increase. (3) Accidental ingestion: taking even one dose by accident, especially by children, can cause a fatal overdose. (4) Benzodiazepines and other central nervous system depressants, including alcohol: using these together with opioids may cause profound sedation, respiratory depression, coma, and death. The label says to reserve this combination for people for whom other treatments are inadequate. (5) Neonatal opioid withdrawal syndrome: extended use during pregnancy may cause withdrawal in the newborn, which can be life-threatening if not recognized and treated. (6) REMS: healthcare providers are strongly encouraged to complete a REMS-compliant education program and counsel patients on serious risks and safe use. (7) CYP3A4 interaction: using this medicine with CYP3A4 inhibitors may increase oxycodone levels in the body, which could increase or prolong side effects.
Used for
The label says it is used to manage pain severe enough to require an opioid analgesic, when alternative treatments are inadequate. The label also says opioid pain medicines should be reserved for people for whom other treatment options are ineffective, not tolerated, or otherwise inadequate.
Comes as
5 mg white, round tablets; 10 mg light pink, round tablets
Common side effects
Nausea, Constipation, Vomiting
| Generic name | Oxycodone hydrochloride |
|---|---|
| Brand names | — |
| Type of medicine | An opioid pain medicine (the label calls it an opioid agonist). It is a Schedule II controlled substance. |
| How it is sold | Prescription pain tablet (immediate-release, taken by mouth) |
| Comes as | 5 mg white, round tablets; 10 mg light pink, round tablets; 15 mg light yellow, round tablets; 20 mg light yellow, round tablets; 30 mg light yellow, round tablets (flat faced); All strengths are immediate-release tablets. Bottles of 100 or 500 tablets are listed. |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-01-14 |
💊 What is Oxycodone Hydrochloride used for?
- The label says it is used to manage pain severe enough to require an opioid analgesic, when alternative treatments are inadequate. The label also says opioid pain medicines should be reserved for people for whom other treatment options are ineffective, not tolerated, or otherwise inadequate.
How it works
The label describes oxycodone as an opioid agonist, which means it is a type of opioid pain medicine. The label text provided does not explain its effects in more detail.
How it is usually taken
- The label says to take this medicine exactly as prescribed, using the lowest dose possible for the shortest time needed. Doses are taken as needed for pain and spaced out over the day, and you should not take more than prescribed. The label says not to change your dose on your own, and not to stop suddenly if you have been taking it regularly without talking to your healthcare provider. If you miss a dose, the label says to take your next dose at your usual time. If the dose does not control your pain, the label says to call your healthcare provider. Follow the instructions from your prescriber or pharmacist.
Comes as
- 5 mg white, round tablets
- 10 mg light pink, round tablets
- 15 mg light yellow, round tablets
- 20 mg light yellow, round tablets
- 30 mg light yellow, round tablets (flat faced)
- All strengths are immediate-release tablets. Bottles of 100 or 500 tablets are listed.
⚠️ Oxycodone Hydrochloride side effects
Common side effects
- Nausea
- Constipation
- Vomiting
- Headache
- Itching (pruritus)
- Trouble sleeping (insomnia)
- Dizziness
- Weakness (asthenia)
- Sleepiness (somnolence)
- Abdominal pain
- Tiredness
Get medical help right away if
- Get emergency medical help or call 911 right away if you have trouble breathing or shortness of breath.
- Get emergency medical help right away for a fast heartbeat or chest pain.
- Get emergency medical help right away for swelling of your face, tongue, or throat.
- Get emergency medical help right away for extreme drowsiness.
- Get emergency medical help right away for light-headedness when changing positions or feeling faint.
- Get emergency medical help right away for agitation, high body temperature, trouble walking, or stiff muscles.
- Get emergency medical help right away for mental changes such as confusion.
🛑 Who should not take Oxycodone Hydrochloride, and who should be careful
The label says not to take it if
- You have significant respiratory depression (slowed or troubled breathing).
- You have severe asthma, trouble breathing, or other lung problems, or acute or severe bronchial asthma in a setting without monitoring or emergency breathing equipment.
- You have a bowel blockage, known or suspected gastrointestinal obstruction (including paralytic ileus), or narrowing of the stomach or intestines.
- You have a known allergy or hypersensitivity to oxycodone (the label mentions anaphylaxis as an example).
Tell your doctor before taking it if
- Tell your healthcare provider about any history of head injury, seizures, or problems urinating.
- Tell your provider about any history of abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
- Tell your provider about liver, kidney, or thyroid problems, or pancreas or gallbladder problems.
- Tell your provider if your pain is getting worse, if you feel more sensitive to pain, or if you have new pain after taking it.
- Tell your provider if you are pregnant or planning to become pregnant, or if you are breastfeeding.
- Tell your provider if you live in a household with small children or someone who has abused street or prescription drugs.
- Tell your provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take.
🔀 Oxycodone Hydrochloride with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Alcohol and products containing alcohol: the label says this can cause you to overdose and die.
- Benzodiazepines, gabapentinoids (gabapentin or pregabalin), other opioid medicines, and other central nervous system depressants, including street drugs: the label says these can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- CYP3A4 inhibitors, such as macrolide antibiotics (for example erythromycin), azole antifungals (for example ketoconazole), and protease inhibitors (for example ritonavir): these can increase oxycodone levels and prolong opioid effects. The label says that if a CYP3A4 inhibitor is stopped, oxycodone levels may fall.
- CYP3A4 inducers: these can decrease oxycodone levels, which may reduce effectiveness or cause withdrawal. The label says that if an inducer is stopped, oxycodone levels may rise and may cause serious breathing problems.
- Prescription and over-the-counter medicines, vitamins, and herbal supplements can interact, so tell your provider about everything you take.
Alcohol and food
The label says not to drink alcohol or use prescription or over-the-counter medicines that contain alcohol while taking this medicine, because this may cause overdose and death. The label text provided does not give food instructions.
🤰 Oxycodone Hydrochloride in pregnancy and breastfeeding
Pregnancy
The label says this medicine may cause fetal harm. It also says that use for an extended period during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. The label states that animal studies did not show teratogenicity at the doses tested, but also that data in pregnant women are insufficient, and it advises that pregnant women be told of the potential risk to a fetus. Discuss pregnancy with your healthcare provider.
Breastfeeding
The label says oxycodone passes into breast milk and may harm a baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness, and seek immediate medical care if you notice these signs.
🗓️ Storage, missed doses and taking too much
Storage
The label says to store this medicine securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. The label text provided does not list a storage temperature. For disposal, the label says to flush expired, unwanted, or unused tablets down the toilet if a drug take-back option is not readily available, and to visit www.fda.gov/drugdisposal for more information.
If a dose is missed
The label says that if you miss a dose, take your next dose at your usual time. Do not take more than your prescribed dose.
If too much is taken
The label says to get emergency help or call 911 right away if you take too much. Signs of acute overdose described in the label include slowed or stopped breathing, sleepiness progressing to stupor or coma, limp muscles, cold and clammy skin, small pupils, and in some cases death. Ask your healthcare provider about medicines such as naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
🗒️ Questions to ask about Oxycodone Hydrochloride
🎯 Check what you understood
1. What does the label say to do if your pain gets worse after taking this medicine?
2. Which combination does the label warn can cause profound sedation, respiratory depression, coma, and death?
3. Which symptom does the label say needs emergency medical help right away?
❓ Oxycodone Hydrochloride: frequently asked questions
Is oxycodone hydrochloride addictive?
The label says that exposure to opioids carries a risk of addiction, abuse, and misuse, which can lead to overdose and death. It also says addiction can occur in people who are appropriately prescribed the medicine.
Can I drink alcohol while taking this medicine?
The label says not to drink alcohol or use products containing alcohol during treatment, because it may cause you to overdose and die.
What should I do if I miss a dose?
The label says to take your next dose at your usual time. It also says not to take more than your prescribed dose.
How should I dispose of leftover tablets?
The label says to flush expired, unwanted, or unused tablets down the toilet if a drug take-back option is not readily available. It directs readers to www.fda.gov/drugdisposal for more information.
Can I stop taking this medicine suddenly?
The label says that if you have been taking it regularly, you should not stop without talking to your healthcare provider. It also says rapid reduction or abrupt discontinuation has resulted in serious withdrawal symptoms in physically dependent patients.
🧪 Tests and reports linked to Oxycodone Hydrochloride
The label text mentions these. If you have one of these reports, get every line of it explained.
- Thyroid tests
a test or report linked to this medicine
- Culture and sensitivity
a test or report linked to this medicine
- Urinalysis
a test or report linked to this medicine
- Pregnancy hCG test
a test or report linked to this medicine
📖 Medical words used on this page
- Acute vs chronic
Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.
- Allergic reaction
An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.
- Anaphylaxis
Anaphylaxis is a severe, whole-body allergic reaction that comes on fast and is a medical emergency needing urgent help.
- Angina
Angina is chest pain or tightness caused by the heart muscle not getting enough blood and oxygen, usually from narrowed heart arteries.
- Antibiotic
An antibiotic is a medicine that kills bacteria or stops them growing; it treats bacterial infections, not viral ones like colds or flu.
- Antifungal
An antifungal is a medicine that treats or prevents infections caused by fungi, such as yeast infections, athlete's foot and ringworm.
- Benzodiazepine
A benzodiazepine is a type of calming medicine used for anxiety, sleep problems, seizures or muscle spasm. It can cause drowsiness and dependence.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Bronchospastic Disease
Bronchospastic disease means a lung condition, such as asthma, in which the airways tend to tighten suddenly (bronchospasm).
- CNS depressant
A CNS depressant is any medicine or substance that slows down brain and nerve activity, causing drowsiness, relaxation or slower breathing.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Controlled substance
A controlled substance is a medicine or drug whose making, prescribing and supply are tightly regulated by law because it can be misused or cause dependence.
- CYP3A
CYP3A is a family of enzymes, mainly in the liver and gut, that break down a large share of commonly used medicines.
- CYP3A Inhibitor
A CYP3A inhibitor is a medicine or food that slows the liver enzyme CYP3A, which can make other medicines build up in the body.
📖 Medical words on this page
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Explain my leafletDecode my prescription🔗 Trusted sources about Oxycodone Hydrochloride
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Oxycodone Hydrochloride on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Search the NHS website for Oxycodone Hydrochloride ↗
UK National Health Service
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
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Source: official FDA drug label (label updated 2026-01-14). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.