Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Dazidox
  2. Eth-Oxydose
  3. Oxaydo
  4. OxyCONTIN
  5. OxyCONTIN CR
  6. Oxydose
  7. Oxyfast
  8. Oxy IR
  9. Roxicodone
  10. Roxicodone Intensol

Descriptions


Oxycodone is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. It belongs to the group of medicines called narcotic analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.

Oxycodone extended-release capsules or tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

This product is available in the following dosage forms:

  • Capsule, Extended Release
  • Tablet, Extended Release
  • Tablet
  • Solution
  • Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Oxaydo®, Roxicodone®, Roxybond™, and Xtampza® ER in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oxycontin® in children. However, safety and efficacy have not been established in children younger than 11 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving oxycodone in order to avoid potentially serious side effects.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Nalmefene
  • Naltrexone
  • Safinamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Acepromazine
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Alvimopan
  • Amifampridine
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Aripiprazole
  • Armodafinil
  • Asenapine
  • Atazanavir
  • Baclofen
  • Benperidol
  • Benzhydrocodone
  • Benzphetamine
  • Boceprevir
  • Bosentan
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clopidogrel
  • Clorazepate
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxylamine
  • Dronedarone
  • Droperidol
  • Duloxetine
  • Efavirenz
  • Eletriptan
  • Enflurane
  • Enzalutamide
  • Erdafitinib
  • Erythromycin
  • Escitalopram
  • Esketamine
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Etravirine
  • Fentanyl
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Idelalisib
  • Imatinib
  • Imipramine
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ivacaftor
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Lanreotide
  • Levomilnacipran
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lofexidine
  • Lomitapide
  • Lopinavir
  • Lorazepam
  • Lorcaserin
  • Lorlatinib
  • Loxapine
  • Lumacaftor
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Methylnaltrexone
  • Metoclopramide
  • Mibefradil
  • Midazolam
  • Mifepristone
  • Milnacipran
  • Mirtazapine
  • Mitotane
  • Moclobemide
  • Modafinil
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nafcillin
  • Nalbuphine
  • Nalorphine
  • Naloxone
  • Naratriptan
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nevirapine
  • Nialamide
  • Nicomorphine
  • Nilotinib
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxcarbazepine
  • Oxymorphone
  • Palbociclib
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Posaconazole
  • Prazepam
  • Prednisone
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Ranitidine
  • Ranolazine
  • Rasagiline
  • Remifentanil
  • Remoxipride
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rizatriptan
  • Samidorphan
  • Saquinavir
  • Scopolamine
  • Secobarbital
  • Selegiline
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Tapentadol
  • Telaprevir
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Verapamil
  • Vilazodone
  • Voriconazole
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • St John's Wort

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing or lung problems (eg, hypoxia) or
  • Cancer of the esophagus or colon or
  • Central nervous system (CNS) depression or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Drug dependence, especially with narcotics, or history of or
  • Enlarged prostate (eg, BPH, prostatic hypertrophy) or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Problems with passing urine or
  • Psychosis (mental disease) or
  • Trouble swallowing or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, acute or severe or
  • Respiratory depression (serious breathing problem) or
  • Stomach or bowel blockage (including paralytic ileus)—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) or
  • Pancreatitis (swelling of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. This medicine should also come with a Medication Guide and a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Oxycodone extended-release capsules or tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the Oxaydo® or OxyContin® tablet whole with water. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time. Also, do not give this medicine through nasogastric or feeding tubes.

If you are using the extended-release capsules:

  • Take this medicine with food and with about the same amount of food each time.
  • If you have trouble swallowing, you may open the capsule and sprinkle the contents on soft foods (eg, applesauce, pudding, yogurt, ice cream, or jam) or into a cup and swallow immediately. Drink a glass of water to make sure all the medicine has been taken.
  • This medicine may also be given through a nasogastric or gastrostomy tube.

Oxycodone extended-release capsules or tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

While taking the Roxybond™ tablet, part of it may pass into your stool. This is normal and nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release capsules):
    • For severe pain:
      • Patients who are not taking narcotic medicines or are not opioid tolerant:
        • Adults—At first, 9 milligrams (mg) every 12 hours with food. Your doctor may adjust your dose as needed. However, the dose is usually not more than 288 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • Patients switching from other narcotic medicines:
        • Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • For moderate to severe pain:
      • Patients switching from regular oxycodone forms:
        • Adults—One tablet every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed.
        • Children 11 years of age and older—Dose must be determined by your doctor. The patient must already be receiving and tolerating opioids for at least 5 days in a row with a minimum of 20 mg per day of oxycodone or its equivalent for at least 2 days before taking OxyContin®.
        • Children younger than 11 years of age—Use and dose must be determined by your doctor.
      • Patients switching from other narcotic medicines:
        • Adults—One tablet every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed.
        • Children 11 years of age and older—Dose must be determined by your doctor. The patient must already be receiving and tolerating opioids for at least 5 days in a row with a minimum of 20 mg per day of oxycodone or its equivalent for at least 2 days before taking OxyContin®.
        • Children younger than 11 years of age—Use and dose must be determined by your doctor.
      • Patients who are not taking narcotic medicines:
        • Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (immediate-release tablets):
    • For moderate to severe pain:
      • Patients who are not taking narcotic medicines:
        • Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • Patients switching from other narcotic medicines:
        • Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage forms (liquid concentrate or solution):
    • For moderate to severe pain:
      • Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For moderate to severe pain:
      • Roxicodone®:
        • Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • Roxybond™:
        • Adults—5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Roxybond™ or Xtampza® ER, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Oxycodone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush any unused medicine down the toilet. Also ask your pharmacist about the best way to dispose of medicine you do not use.

Precautions

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, or cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

For nursing mothers taking Roxybond™ or Xtampza® ER:

  • Talk to your doctor if you have any questions about taking oxycodone or about how this medicine may affect your baby.
  • Call your doctor if you become extremely tired and have difficulty caring for your baby.
  • Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
  • Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Chills
  2. cold sweats
  3. confusion
  4. difficult or labored breathing
  5. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  6. fever
  7. tightness in the chest
  8. twitching

Rare

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. blood in the urine
  3. burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. chest pain
  5. cough
  6. decrease in the frequency of urination
  7. decreased urine output
  8. difficult or painful urination
  9. difficulty in passing urine (dribbling)
  10. difficulty with swallowing
  11. dizziness
  12. dry mouth
  13. fainting
  14. fast, irregular, pounding, or racing heartbeat or pulse
  15. feeling of warmth or heat
  16. flushing or redness of the skin, especially on the face and neck
  17. frequent urination
  18. headache
  19. hives, itching, or skin rash
  20. increase in heart rate
  21. increased thirst
  22. increased volume of pale, dilute urine
  23. lightheadedness
  24. muscle pain or cramps
  25. nausea
  26. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  27. rapid breathing
  28. rapid weight gain
  29. seizures
  30. severe constipation
  31. severe vomiting
  32. stomach pain
  33. sunken eyes
  34. sweating
  35. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  36. thirst
  37. trembling or shaking of the hands or feet
  38. unusual tiredness or weakness
  39. unusual weight gain or loss
  40. vomiting
  41. wrinkled skin

Incidence not known

  1. Blurred vision
  2. choking
  3. clay-colored stools
  4. cold, clammy skin
  5. dark urine
  6. diarrhea
  7. fast, weak pulse
  8. gagging
  9. irregular, fast, slow, or shallow breathing
  10. loss of appetite
  11. loss of consciousness
  12. pale or blue lips, fingernails, or skin
  13. unpleasant breath odor
  14. very slow heartbeat
  15. yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Change in consciousness
  2. chest pain or discomfort
  3. constricted, pinpoint, or small pupils (black part of the eye)
  4. decreased awareness or responsiveness
  5. extreme drowsiness
  6. loss of consciousness
  7. no muscle tone or movement
  8. severe sleepiness
  9. slow or irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Difficulty having a bowel movement
  2. drowsiness
  3. lack or loss of strength
  4. relaxed and calm feeling
  5. sleepiness or unusual drowsiness

Less common

  1. Abnormal dreams
  2. anxiety
  3. belching
  4. burning feeling in the chest or stomach
  5. false or unusual sense of well-being
  6. heartburn
  7. hiccups
  8. indigestion
  9. stomach discomfort or upset
  10. tenderness in the stomach area
  11. trouble sleeping
  12. weight loss

Rare

  1. Absent, missed, or irregular menstrual periods
  2. bad, unusual or unpleasant (after) taste
  3. bloated or full feeling
  4. body aches or pain
  5. change in taste
  6. change in walking and balance
  7. changes in vision
  8. clumsiness or unsteadiness
  9. congestion
  10. continuous ringing or buzzing or other unexplained noise in the ears
  11. crying
  12. decreased interest in sexual intercourse
  13. deep or fast breathing with dizziness
  14. delusions of persecution, mistrust, suspiciousness, or combativeness
  15. dental caries or tooth decay
  16. depression
  17. difficulty with speaking
  18. dry skin
  19. dryness or soreness of the throat
  20. excess air or gas in the stomach or bowels
  21. excessive muscle tone
  22. feeling of constant movement of self or surroundings
  23. feeling of unreality
  24. general feeling of discomfort or illness
  25. headache, severe and throbbing
  26. hearing loss
  27. hoarseness
  28. inability to have or keep an erection
  29. increase in body movements
  30. increased appetite
  31. increased cough
  32. irritability
  33. loss in sexual ability, desire, drive, or performance
  34. loss of heat from the body
  35. loss of memory
  36. loss of strength or energy
  37. muscle pain or weakness
  38. muscle stiffness, tension, or tightness
  39. neck pain
  40. numbness of the feet, hands, and around the mouth
  41. passing of gas
  42. problems with memory
  43. quick to react or overreact emotionally
  44. rapidly changing moods
  45. red, swollen skin
  46. restlessness
  47. runny nose
  48. scaly skin
  49. sensation of spinning
  50. sense of detachment from self or body
  51. severe sleepiness
  52. swelling or inflammation of the mouth
  53. voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.