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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Generic drug name: acetaminophen and hydrocodone (a seat a MEE noe fen and hye droe KOE done)
Brand name(s): ANEXSIA, BANCAP-HC, HYDROGESIC, LORTAB, PROCET, VICODIN
GENERIC: available FAMILIES: Non-Narcotic Painkillers, Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Generic drug name: hydrocodone (hye droe KOE done)
Brand name(s): HYSINGLA ER, NORCO, VANTRELA ER, ZOHYDRO ER, ZOHYRDRO
GENERIC: not available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Generic drug name: hydrocodone and ibuprofen (hye droe KOE done and eye byoo PROE fen)
Brand name(s): REPREXAIN, VICOPROFEN
GENERIC: not available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Generic drug name: hydromorphone (hye dro MOR fone)
Brand name(s): DILAUDID, DILUDID-5, EXALGO
GENERIC: available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Generic drug name: morphine (MOR feen)
Brand name(s): ARYMO ER, KADIAN, MORPHABOND ER, MS CONTIN, ROXANOL
GENERIC: available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: acetaminophen and codeine (a seat a MEE noe fen and KOE deen)
Brand name(s): TYLENOL WITH CODEINE
GENERIC: available FAMILIES: Non-Narcotic Painkillers, Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: acetaminophen and oxycodone (a seat a MEE noe fen and ox ee KOE done)
Brand name(s): OXYCET, PERCOCET, ROXICET, TYLOX, XARTEMIS XR
GENERIC: available FAMILIES: Non-Narcotic Painkillers, Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: aspirin and oxycodone (AS per in and ox ee KOE done)
Brand name(s): PERCODAN
GENERIC: available FAMILIES: Opiate-containing Painkillers, Salicylates
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: codeine (KOE deen)
Brand name(s):
GENERIC: available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: meperidine (me PER i deen)
Brand name(s): DEMEROL
GENERIC: available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: oxycodone (ox ee KOE done)
Brand name(s): OXAYDO, OXYCONTIN, ROXICODONE, ROXICODONE INTENSOL, XTAMPZA ER
GENERIC: available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Some opioids caused fetal harm in animal studies including neurological, soft tissue, and skeletal abnormalities; exposure during pregnancy was also associated with reduction in growth and a number of behavioral abnormalities. In humans, infants born to mothers who have taken opioids chronically may exhibit withdrawal symptoms (irritability and excessive crying, tremors, hyperactive reflexes, diarrhea, sneezing, yawning, vomiting, and fever), reversible reduction in brain volume, small size, and increased risk of sudden infant death syndrome. These drugs should be used by a pregnant woman only if the need for opioid analgesia clearly outweighs the potential risks to the fetus.

Breast-feeding Warning

It is known that some of these drugs are excreted in human milk. Because of the potential for serious adverse effects in nursing infants, you should not take these drugs while nursing.

Safety Warnings For This Drug [top]

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Codeine is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of codeine in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.

FDA BLACK-BOX WARNING for all other opioids, including codeine(OXYCONTIN label is used as a representative example)

Addiction, Abuse and Misuse

OXYCONTIN exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OXYCONTIN and monitor all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCONTIN. Monitor for respiratory depression, especially during initiation of OXYCONTIN or following a dose increase. Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing, or dissolving OXYCONTIN tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone.

Accidental Ingestion

Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of OXYCONTIN during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of OXYCONTIN with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCONTIN and any CYP3A4 inhibitor or inducer.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death.

  • Reserve concomitant prescribing of OXYCONTIN Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

 

One hazard of taking these drugs continuously for longer than several weeks is drug-induced dependence. Do not stop taking your drug suddenly. With the help of your doctor, work out a schedule for slowly lowering the amount of the drug you take by about 5 to 10 percent each day. Keep a written record of the dosage reduction schedule with you. These steps will make it much easier to become drug free without developing distressing symptoms of drug withdrawal.

These drugs can increase the risk of hip fracture.

Facts About This Drug [top]

Codeine, hydrocodone, hydromorphone, meperidine and oxycodone are narcotics or opioids basically derived from morphine. They are approved by the Food and Drug Administration (FDA) to relieve pain but are sometimes also used to treat cough and diarrhea not caused by poison. They also are used as sedatives to cause drowsiness before an operation. These drugs can be habit-forming and have many adverse effects. Their use should be limited to the lowest dose for the shortest period of time, except...

Codeine, hydrocodone, hydromorphone, meperidine and oxycodone are narcotics or opioids basically derived from morphine. They are approved by the Food and Drug Administration (FDA) to relieve pain but are sometimes also used to treat cough and diarrhea not caused by poison. They also are used as sedatives to cause drowsiness before an operation. These drugs can be habit-forming and have many adverse effects. Their use should be limited to the lowest dose for the shortest period of time, except in cases of terminally ill people with extraordinary pain.

Patients taking any of the combination drugs listed at the top of this page should also read the information about acetaminophen (TYLENOL), ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) or aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN).

Public Citizen has categorized acetaminophen and codeine (TYLENOL WITH CODEINE), acetaminophen and oxycodone (PERCOCET, ROXICET, TYLOX), aspirin and oxycodone (PERCODAN), codeine, meperidine (DEMEROL) and oxycodone (OXYCONTIN, ROXICODONE INTENSOL) as Limited Use drugs. Public Citizen has categorized hydrocodone (ZOHYDRO) as Do Not Use.

Adverse effects

Narcotic drugs affect the central nervous system, producing pain relief and drowsiness, as well as less desirable effects. Older adults may require less than the usual adult dose to produce desired effects because older people have greater sensitivity to the drugs. Some of the adverse effects frequently seen in older adults are slow or troubled breathing (narcotics should never be given to anyone with slowed breathing), stimulation or confusion,[1] and hallucinations and unpleasant dreams.[2]

Patients who frequently use medication to relieve headache pain may develop a condition known as medication overuse headache (MOH). According to a 2004 review published in the medical journal Lancet Neurology,[3] there is substantial evidence that all headache drugs can cause MOH in patients who use these drugs excessively. The narcotic or opioid painkillers that are derivatives of morphine and codeine can cause MOH.

Patients experiencing MOHs should discuss with their doctors the important details of their headaches and, depending on the individual case, the type of withdrawal from the MOH-causing drugs that is best. [4]

For more information about adverse effects of these drugs, see the “Adverse Effects” section below.

Meperidine (DEMEROL)

After expert analysis, meperidine has been deemed inappropriate for use in older adults because the drug is not particularly effective in the commonly prescribed oral doses. It also may cause confusion and has many disadvantages over other narcotic drugs.[5]

Overprescribing of and ease of access to narcotics

In 2012, Public Citizen, along with 36 doctors, researchers and public health officials, petitioned the FDA to require changes in the drug labeling for opioid pain medications in an effort to reduce the massive overprescribing of these medications. At that time, the labels of opioid analgesics simply stated that they were approved for moderate-to-severe pain. The petition called for striking the term “moderate,” inserting a suggested duration of use and adding a suggested maximum dose equivalent of 100 milligrams of morphine. The requested changes relate only to opioids used for noncancer pain. In 2013, the FDA granted the petition in part by requiring that the product labeling of extended-release and long-acting opioids be revised to state that the drugs are indicated for “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” However, the FDA denied the petition’s request to require changes suggesting a maximum dose and duration of use for opioids. As a result, drug companies can continue to promote these pain medications as safe and effective for long-term use by noncancer patients where risks are likely to outweigh benefits.

In testimony before an FDA advisory committee, West Virginia Senator Joe Manchin spoke in troubling terms about the ease of access to hydrocodone, stating: “For underage children, these drugs are easier to get than beer or cigarettes.”

Public Citizen testified in the same January 2013 hearing at which Sen. Manchin spoke. Our testimony supported increased regulatory control by moving hydrocodone out of the dangerously loosely regulated Narcotics Schedule III and reclassifying it as Schedule II. Public Citizen pointed out that the total defined daily dose (a statistical measure of drug consumption) of hydrocodone consumption for a year among the entire U.S. population is 2.8 billion doses, which translates to almost eight doses per person per year. The drug has since been reclassified as Schedule II.

Regulatory actions surrounding narcotics

2005: The FDA asked the manufacturer of the long-acting morphine product KADIAN to add to the drug’s professional product label a warning about a possible interaction with alcohol.[6]

2007: The FDA issued a public health advisory with important new information about a very rare but serious adverse effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Nursing mothers taking codeine may have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal adverse effects in nursing babies.[7]

2011: The FDA issued an advisory concerning the strength of acetaminophen in prescription-drug products. The FDA requested that drug manufacturers limit the strength of acetaminophen in prescription-drug products to 325 milligrams per tablet. The agency also required that a black-box warning, the agency's strongest warning, be added to the drug label of all acetaminophen-containing prescription products that would highlight the potential for severe liver injury. The agency stated that another warning highlighting the potential for allergic reactions (swelling of the face, mouth and throat; difficulty breathing; itching; or rash) also would be added to the drug label.[8]

2012: The FDA announced that it was reviewing data on the safety of codeine use in children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Reports of deaths have occurred in these cases. Many of the cases of serious adverse events or death occurred in children with obstructive sleep apnea who received codeine after a tonsillectomy and/or adenoidectomy.[9]

2013: The FDA announced that a new black-box warning would be added to the drug label of codeine-containing products to address the use of codeine for pain management in postoperative pain for children after tonsillectomy and/or adenoidectomy. A black-box warning is the FDA’s strongest warning. The Warnings/Precautions, Pediatric Use, and Patient Counseling Information sections of the drug label will also be updated. A contraindication will be added to restrict codeine from being used in this setting.[10]

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee and the Canadian agency Health Canada also issued a similar recommendation for restrictions on the use of codeine for pain relief in children.[11][12]

2016: The FDA issued a safety warning for the entire opioid class of drugs concerning potential harmful interactions with other medications, problems with the adrenal glands, and decreased sex hormone levels.[13]

The FDA required the addition of a black-box warning to opioid and benzodiazepine drugs stating that profound sedation, depressed breathing, coma and death can occur when these medications are used together.

2017: The FDA announced that it was restricting the use of codeine in children and requiring changes in the product labeling accordingly.[14] Codeine should not be used to treat pain or cough. A new warning was added that codeine is not recommended in adolescents between 12 and 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe lung disease. A strengthened warning was added that codeine is not recommended in mothers who are breast-feeding because of the risk of serious adverse reactions in breastfed infants.

Before You Use This Drug [top]

Do not use if you have or have had:

  • respiratory depression
  • diarrhea caused by antibiotics or poisoning
  • are breast-feeding

Tell your doctor if you have or have had:

  • an unusual reaction to any narcotics
  • brain disease or head injury
  • recent surgery in gastrointestinal tract
  • colitis (inflammation of the colon)
  • emphysema, asthma, or other lung disease
  • enlarged prostate or trouble urinating
  • gallbladder disease or gallstones
  • heart, kidney, or liver problems
  • seizures
  • underactive thyroid gland
  • alcohol or drug abuse
  • emotional problems
  • pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Do not drink alcohol or take any drugs that make you drowsy unless you have checked with your doctor first. When codeine is combined with these substances, it will make you even more drowsy, which puts you at risk of having accidents.
  • Do not drive or perform other activities that require alertness, because this drug may make you drowsy, dizzy, or lightheaded.
  • If this drug seems less effective after a few weeks of use, do not increase the dose. Call your doctor instead.
  • Lie down if you have nausea, vomiting, dizziness, or lightheadedness.
  • If you use this drug for a long time, have regular checkups.
  • You may feel dizzy when rising from a lying or sitting position. If you are lying down, hang your legs over the side of the bed for a few minutes, then get up slowly. When getting up from a chair, stay by the chair until you are sure that you are not dizzy.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.
  • Check with your doctor before discontinuing medication after prolonged use or high doses.
  • Use sugarless gum or candy, ice, or a saliva substitute for dry mouth.
  • Get emergency help at once if you suspect an overdose.

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Meperidine syrup: mix with one half glass (four ounces) of water.
  • Morphine oral liquid: may be mixed with fruit juice to improve taste.
  • Morphine and oxycodone extended-release tablets: swallow whole; do not break, crush, or chew.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children. Protect liquid form from freezing.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

abciximab, acetazolamide, AGGRASTAT, alcohol, aluminum/magnesium antacids, AMARYL, ANTURANE, ardeparin, CAPOTEN, captopril, carbamazepine, certoparin, chlorpromazine, chlorpropamide, cimetidine, clopidogrel, COUMADIN, danaparoid, DEPAKENE, DIABINESE, , digoxin, DILANTIN, enoxaparin, eptifibatide, glimepiride, GLUCHOPHAGE, GLUCOVANCE, heparin, INTEGRILIN, ketorolac, LANOXIN, LOVENOX, methotrexate, MEDROL, MERIDIA, METAGLIP, metformin, MEXATE, methylprednisolone, nadroparin, naltrexone, NARDIL, NORVIR, PENTOTHAL, phenelzine, phenytoin, PLAVIX, quinidine, reteplase, REVIA, ritonavir, sibutramine, sulfinpyrazone, TAGAMET, TEGRETOL, thiopental, THORAZINE, TICLID, ticlopidine, tirofiban, TORADOL, tramadol, trovafloxacin, TROVAN, TUBARINE, tubocrarine, ULTRAM, valproic acid, warfarin.

These drugs will increase the effects of other drugs that cause dizziness or drowsiness.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • feelings of unreality
  • hallucinations
  • unusual excitement or restlessness
  • skin rash, hives, or itching
  • depression or other mood or mental change
  • ringing or buzzing sound in ears
  • slow, irregular, or troubled breathing
  • swollen, red, or flushed face (more often with meperidine or methadone)
  • trembling or uncontrolled or rigid muscle movements
  • abnormal (slow, fast, or pounding) heartbeat
  • increased sweating (more often with meperidine and methadone)

Call your doctor if these symptoms continue:

  • dizziness
  • drowsiness
  • confusion
  • headache
  • feeling faint or lightheaded
  • nausea or vomiting (which might go away if you lie down for a while)
  • loss of appetite
  • stomach cramps or pain
  • constipation (more often seen with long-term use and with codeine)
  • dry mouth
  • false sense of well-being
  • general feeling of discomfort or illness
  • nervousness or restlessness
  • unusual tiredness or weakness
  • nightmares, unusual dreams or insomnia
  • difficult or painful urination, frequent urge to urinate, abnormal decrease in amount of urine
  • vision changes (especially blurry vision or double vision)
  • redness
  • swelling
  • pain or burning at place of injection
  • sexual problems

Call your doctor if these symptoms continue after you stop taking this drug:

  • shivering or trembling
  • stomach cramps
  • body aches
  • diarrhea
  • fast heartbeat
  • fever, runny nose, or sneezing
  • increased yawning
  • loss of appetite
  • nausea or vomiting
  • unusual excitement, nervousness, or restlessness
  • trouble sleeping
  • unusually large pupils
  • weakness or tiredness

Signs of overdose:

  • cold, clammy skin
  • seizures
  • severe dizziness or drowsiness
  • severe nervousness or restlessness
  • confusion
  • convulsions
  • pinpoint pupils
  • unconsciousness
  • abnormally low blood pressure
  • slow heartbeat
  • slow or troubled breathing
  • severe weakness

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • respiratory function tests

last reviewed August 31, 2021