Tapentadol belongs to a class of pain relievers known as opioid analgesics (also known as narcotic analgesics) that act on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

It is used to treat moderate to severe pain in adults.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose (for people who are not currently taking opioid pain relievers) is 50 mg to 100 mg every 4 to 6 hours depending on the level of your pain. The dose may be increased depending on how the medication is tolerated and how well it works for your pain. The maximum total daily dose on the first day is 700 mg. On the second and subsequent days of treatment, the maximum total daily dose is 600 mg.

If you have been taking another opioid medication, the starting dose of tapentadol may be higher, depending on the dose of the other medication. Your doctor will determine the most appropriate starting dose.

You may take the tablets on an empty stomach or with meals. Always swallow the tablet whole with sufficient liquid. Do not crush, break, chew or dissolve the tablets, as this can be dangerous and potentially cause serious harm or death.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Stopping the medication suddenly may cause withdrawal symptoms (such as restlessness, irritability, nausea and vomiting, diarrhea, sweating, chills, muscle aches, or watery eyes and nose). Do not stop taking this medication without checking with your doctor first. Your doctor will advise you on how to stop the medication safely.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children and pets. Accidental use by a child is a medical emergency and may result in death.

50 mg
Each yellow, round, biconvex, film-coated tablet debossed with "O-M" on one side and "50" on the other side contains 50 mg of tapentadol. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K29 to K32). Film coating: D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

75 mg
Each yellow-orange, round, biconvex, film-coated tablet debossed with "O-M" on one side and "75" on the other side contains 75 mg of tapentadol. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K29 to K32). Film coating: D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

100 mg
Each orange, round, biconvex, film-coated tablet debossed with "O-M" on one side and "100" on the other side contains 100 mg of tapentadol. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K29 to K32). Film coating: FD&C Yellow No. 6 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Do not take tapentadol if you:

• are allergic to tapentadol or any ingredients of the medication
• are allergic to opioids
• are also taking MAO inhibitors (certain medications used for treatment of depression) or have taken them in the last 14 days before treatment with tapentadol
• are pregnant, in labour, or breast-feeding
• have a head injury, increased intracranial pressure (pressure inside the head), or severe central nervous system depression (a slowing of the central nervous system leading to decreased heart rate, decreased breathing rate, or loss of consciousness)
• have asthma or dangerously slow or shallow breathing (respiratory depression, hypercapnia)
• have respiratory depression (decreased breathing with increased carbon dioxide in the blood)
• have convulsions or a seizure disorder
• have pain that can be controlled by occasional use of painkillers or by painkillers available without a prescription
• have paralysis of the gut or a bowel obstruction
• have severe kidney or liver dysfunction
• are addicted to alcohol
• have an abdominal condition that may require surgery (e.g., acute appendicitis or pancreatitis)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• decreased interest in sexual activity
• decreased sexual ability
• dizziness
• drowsiness
• dry mouth
• headache
• itchiness
• nausea
• poor appetite
• sweating
• tiredness
• trouble sleeping
• vision problems
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• decreased coordination
• fainting
• fast, slow or pounding heartbeat
• opioid withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety, and shivering (these may occur after converting from your previous opioid analgesic to tapentadol or converting from tapentadol to another opioid)
• severe dizziness when getting up from a sitting or lying position

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of a bowel blockage (e.g., severe constipation, abdominal pain, nausea)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• symptoms of too much medication (e.g., extreme sleepiness, a slow heartbeat, cold, clammy skin, feeling faint, confused, or being unable walk or talk normally)
• trouble breathing or slow or shallow breathing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal (stomach) conditions: As with other narcotic medications, tapentadol may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Accidental use: When tapentadol is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are especially at risk. Keep this medication out of sight and reach of children.

Addiction: Tapentadol may lead to physical and psychological addiction. Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medications, or street drugs.

Adrenal gland problems:  People who take opioid medications, such as tapentadol, for more than 1 month may experience symptoms of decreased adrenal gland function. The adrenal gland produces certain hormones that keep the body functioning normally. If you experience nausea or vomiting, decreased appetite, and feelings of tiredness, weakness, or dizziness, talk to your doctor.

Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol and should avoid combining it with other medications, such as narcotic pain relievers, sedatives, or anxiety medications, that cause drowsiness. Doing so can cause additive drowsiness and reduced breathing, as well as other side effects, which can be dangerous and possibly fatal.

Breathing: Tapentadol can suppress breathing. This effect on breathing may be more pronounced for people with breathing problems, brain damage, or who are taking other medications that suppress breathing (e.g., codeine, morphine). If you have breathing problems, such as COPD, asthma or respiratory depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Constipation: Constipation happens frequently while taking opioid (narcotic) pain relievers on a regular basis. Your doctor will discuss the use of stimulant laxatives, stool softeners, and other measures to be used as required.

Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with this medication. Severe withdrawal symptoms may be experienced (e.g., seizures) if the dose is significantly reduced or suddenly stopped. Withdrawal symptoms include irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.

Drowsiness/reduced alertness: This medication may cause drowsiness or reduced alertness. Avoid driving or engaging in other activities requiring alertness unless and until you know how the medication affects you. Alcohol and antianxiety medications can increase the drowsiness caused by this medication.

Head injury: Tapentadol can cause increased pressure inside the head. If you have acute head injuries or other conditions which increase their intracranial pressure (pressure inside the head) discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The safety and effectiveness of tapentadol has not been established for people with reduced kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Overdose: If you experience the following symptoms after taking very high doses, seek medical help immediately:

• breathing that is stopped or dangerously slow or shallow
• collapse
• disturbed consciousness or coma (deep unconsciousness)
• drop in blood pressure
• fast heartbeat
• pin-point pupils
• vomiting
• seizures

Pancreatitis: If you have a history of pancreatitis (inflammation of the pancreas), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Seizures: There have been reports of seizures occurring with tapentadol. Seizures are more likely to occur when higher doses of this medication are taken. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin Syndrome: Severe reactions are possible when tapentadol is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

Pregnancy: This medication should not be used during pregnancy, prior to or during labour. Infants born to mothers who have taken tapentadol during pregnancy have been born with signs of narcotic withdrawal. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication can pass into breast milk. If you are a breast-feeding mother and are taking tapentadol, it may cause life-threatening breathing problems for your baby. This medication is not recommended for breast-feeding mothers.

Children: The safety and effectiveness of using this medication have not been established for children. Tapentadol is not recommended for use by people under 18 years of age.

Seniors: Seniors are at an increased risk of experiencing side effects of tapentadol. Your doctor may prescribe a lower dose than those recommended here.

There may be an interaction between tapentadol and any of the following:

• aclidinium
• alcohol
• alpha agonists (e.g., clonidine, guanfacine)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• anti-emetic medications (dimenhydrinate, granisetron, ondansetron)
• antihistamines (e.g., azelastine, bilastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
• anti-Parkinson's medications (e.g., entacapone, pramipexole, ropinirole, rotigotine, rasagiline, safinamide, selegiline)
• antipsychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• atropine
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• benztropine
• brimonidine
• buprenorphine
• cannabis
• carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide)
• chloral hydrate
• clidinium
• darifenacin
• desmopressin
• diphenoxylate
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• domperidone
• efavirenz
• esketamine
• fesoterodine
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• ipratropium
• kava kava
• ketotifen
• lemborexant
• linezolid
• lithium
• metoclopramide
• methadone
• methylene blue
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• naltrexone
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tramadol)
• oxybutynin
• pizotifen
• pomalidomide
• pramipexole
• pregabalin
• prucalopride
• ropinirole
• rotigotine
• St. John's wort
• seizure medications (e.g., clobazam, carbamazepine, levetiracetam, phenobarbital, phenytoin, primidone, rufinamide, topiramate, valproic acid)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• solifenacin
• somatostatin analogues (e.g., lanreotide, octreotide, pasireotide)
• tetrabenazine
• thalidomide
• tiotropium
• tizanidine
• tolterodine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
• "triptan" migraine medications (e.g., eletriptan, sumatriptan)
• trospium
• tryptophan
• umeclidinium
• vilazodone
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.