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Description

Generic Name

Tramadol hydrochloride

Active Ingredient

Tramadol hydrochloride

Chemical Name and Composition

Tramadol hydrochloride is chemically described as (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride.

Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder. It is readily soluble in water and in ethanol. It has a molecular weight of about 299.84. It is a synthetic, centrally acting analgesic.

Medication Classification

Tramadol is a centrally acting opioid analgesic with a dual mechanism of action. It works in two ways:

• Mu-opioid receptor agonism: Tramadol and its active metabolite (M1) bind to opioid receptors in the central nervous system to change how the body senses and responds to pain.
• Monoamine reuptake inhibition: It blocks the reuptake of norepinephrine and serotonin, two nerve signaling chemicals, which also contributes to pain relief.

Tramadol is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indications

• Immediate-release tablets (Ultram) are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.
• Extended-release tablets and capsules (ConZip and others) are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in adults for whom alternative treatments are inadequate. The extended-release form is not for use as an as-needed (PRN) pain reliever.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Immediate-release oral tablets
  • Extended-release oral tablets
  • Extended-release oral capsules
• Route of Administration: Oral
• Common Strengths:
• • Immediate-release tablets: 50 mg
  • Extended-release tablets: 100 mg, 200 mg, and 300 mg
  • Extended-release capsules: 100 mg, 150 mg, 200 mg, and 300 mg

Formulations and strengths may vary by manufacturer. Confirm the exact strength on your product label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Immediate-release tablets may contain microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and colorants. Extended-release tablets and capsules may contain hypromellose, polyethylene oxide, ethylcellulose, and other release-controlling agents, along with a film coating. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take tramadol exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your pain, your prior opioid use, and your overall health. Do not change your dose on your own.

How to Take Tramadol

• Immediate-release tablets: Swallow with water. These are usually taken every 4 to 6 hours as needed for pain, following your provider's directions.
• Extended-release tablets and capsules: Swallow whole, one at a time, with enough water to make sure it goes down right away. Take these on a regular schedule, usually once daily.
• Never crush, chew, break, cut, or dissolve an extended-release tablet or capsule. Doing so can release a fatal dose all at once.
• Do not pre-soak, lick, or wet the extended-release product before placing it in your mouth.
• Do not take more than prescribed, and do not take it more often than directed.

General Dosing Principles

• Dosing is individualized based on the severity of pain, your response, and your prior opioid experience.
• The immediate-release and extended-release forms are not interchangeable milligram-for-milligram.
• The maximum daily dose is limited, and your provider will not exceed the recommended ceiling because higher doses raise the risk of seizures.
• Your provider will select the exact dose, strength, and schedule for your situation and may adjust it based on your response and side effects.

Food Considerations

Tramadol may be taken with or without food. Take extended-release products in a consistent way each day. Avoid alcohol entirely while taking tramadol. Drinking alcohol or taking products that contain alcohol with the extended-release form can cause it to release the drug too quickly, leading to a dangerous or fatal overdose.

Missed Dose Instructions

• Immediate-release tablets are often taken only when you have pain, so a missed dose may not be a concern. Take it when needed, following your provider's directions.
• Extended-release tablets and capsules: If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If you are unsure what to do, contact your healthcare provider or pharmacist.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children. Accidental use by a child can be fatal.

Disposal

Because tramadol is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, the FDA recommends flushing certain opioid products, including tramadol, down the toilet to prevent accidental exposure. Follow the disposal instructions on your product label or ask your pharmacist. Accidental exposure, especially in children, can cause serious harm or death.

Special Instructions

Children: Tramadol is not for use in children. It is contraindicated in all children younger than 12 years of age and in children younger than 18 years of age after surgery to remove the tonsils or adenoids. Serious and fatal breathing problems have occurred in some children, especially those who process tramadol quickly ("ultra-rapid metabolizers"). Keep the medication where children cannot reach it. Accidental ingestion by a child can cause fatal respiratory depression. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of tramadol, including sedation, confusion, dizziness, constipation, and breathing problems. A provider may start at a lower dose and monitor closely, given the higher risk of falls and possible reduced liver, kidney, or lung function.

Patients with Liver Problems: Use with caution. Tramadol is broken down by the liver, so impaired liver function can increase drug levels and prolong effects. Extended-release forms are generally not recommended for patients with severe liver problems, and immediate-release dosing may need to be reduced.

Patients with Kidney Problems: Use with caution. Tramadol and its active metabolite are removed from the body partly through the kidneys, so reduced kidney function can increase drug levels. Your provider may extend the time between doses. Extended-release forms are generally not recommended for patients with severe kidney problems.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, or trouble waking the patient, and seek emergency care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking tramadol suddenly after prolonged use. Abrupt discontinuation can cause opioid withdrawal symptoms.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, widened pupils, irritability, anxiety, backache, joint pain, weakness, stomach cramps, trouble sleeping, nausea, loss of appetite, vomiting, and diarrhea. Because tramadol also affects serotonin and norepinephrine, some people may notice added symptoms such as anxiety, panic, hallucinations, or unusual sensations.
• Tell your provider if withdrawal symptoms occur so the taper can be adjusted.

Overdose Warning

An overdose of tramadol can be serious and may be fatal, especially when combined with benzodiazepines, alcohol, or other CNS depressants. Symptoms of overdose may include:

• Slowed, shallow, or stopped breathing
• Extreme drowsiness or difficulty staying awake
• Loss of consciousness or coma
• Limp or weak muscles
• Cold, clammy skin
• Pinpoint pupils
• Slow heartbeat or low blood pressure
• Seizures

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Naloxone may be used to reverse an opioid overdose, though it may only partly reverse tramadol's effects and can increase the risk of seizures. Repeated doses of naloxone may be needed, and the patient should be watched closely for an extended period, even after the first dose.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking tramadol and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or stopped breathing; extreme sleepiness; or difficulty waking. This risk is highest when starting treatment, after a dose increase, or when combined with other CNS depressants.
• Seizures: Tramadol may increase the risk of seizures, particularly at higher doses, in people with a seizure disorder, or when taken with certain other medicines.
• Serotonin syndrome: Agitation, hallucinations, fast heartbeat, fever, excessive sweating, shivering, shaking, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea, especially when taken with other serotonergic medicines.
• Suicidal thoughts: New or worsening depression or thoughts of harming yourself. The risk may be higher in people who are prone to addiction or who take certain other medicines.
• Severe allergic reactions (including anaphylaxis): Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Adrenal insufficiency: Ongoing nausea, vomiting, loss of appetite, dizziness, or severe weakness.
• Severe low blood pressure: Dizziness, lightheadedness, or fainting, especially when standing up.
• Severe constipation or bowel obstruction: Ongoing constipation, stomach pain, or inability to have a bowel movement.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Nausea
• Dizziness
• Constipation
• Drowsiness or sleepiness
• Headache
• Vomiting
• Dry mouth
• Sweating
• Itching

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Ultra-Rapid Metabolism and Death in Children; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; and Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

• Addiction, abuse, and misuse: Tramadol exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and monitor throughout treatment.
• Life-threatening respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur. The risk is greatest during treatment initiation and after a dose increase. Monitor closely, especially when starting treatment and after dose increases.
• Ultra-rapid metabolism and death in children: Some people convert tramadol to its active form quickly ("ultra-rapid metabolizers"), which can cause dangerously high drug levels. Deaths have occurred in children, especially after surgery to remove the tonsils or adenoids. Tramadol is contraindicated in children younger than 12 and in children younger than 18 after such surgery.
• Accidental ingestion: Accidental ingestion of even one dose, especially by children, can result in fatal overdose. Store securely and out of reach.
• Neonatal opioid withdrawal syndrome (NOWS): Prolonged use during pregnancy can result in NOWS, which may be life-threatening if not recognized and treated.
• Risks from concomitant use with benzodiazepines or other CNS depressants: Combining tramadol with these substances may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative options, and limit the dose and duration.

Conditions to Disclose to Your Healthcare Provider

Before taking tramadol, tell your healthcare provider if you have or have had any of the following:

• Seizures or a seizure disorder, or conditions that raise seizure risk
• Breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea
• Liver or kidney problems
• A head injury, brain tumor, or a condition causing increased pressure in the brain
• Adrenal gland problems, such as Addison's disease
• Low blood pressure or fainting spells
• Enlarged prostate or urination problems
• Gallbladder, pancreas, or thyroid problems
• Mental health conditions, including depression or thoughts of suicide
• Trouble swallowing, or a narrowing or blockage in your stomach or intestines
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Recent use of an MAOI (within the past 14 days)
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take tramadol if you:

• Are a child younger than 12 years of age
• Are a child younger than 18 years of age who recently had surgery to remove the tonsils or adenoids
• Have significant respiratory depression
• Have acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
• Have a known or suspected gastrointestinal obstruction, including paralytic ileus
• Are taking, or have taken within the past 14 days, a monoamine oxidase inhibitor (MAOI), because this can cause serious and possibly fatal interactions, including serotonin syndrome and seizures
• Have a known hypersensitivity to tramadol, other opioids, or any component of the formulation

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because tramadol is processed mainly by the CYP2D6 and CYP3A4 liver enzymes, many drugs can affect its levels. Key interactions include:

• Monoamine oxidase inhibitors (MAOIs): Combined use, or use within 14 days of an MAOI, may cause serious, possibly fatal reactions, including serotonin syndrome, seizures, and dangerous blood pressure changes. This combination is contraindicated.
• SSRIs, SNRIs, and other serotonergic drugs: Combined use with certain antidepressants, triptans, or other serotonergic medicines may increase the risk of serotonin syndrome and may also lower the seizure threshold.
• Benzodiazepines and other CNS depressants: Combined use increases the risk of profound sedation, respiratory depression, coma, and death. This includes sedatives, tranquilizers, muscle relaxants, sleep medications, other opioids, and alcohol.
• Alcohol: Drinking alcohol or taking products that contain alcohol can cause the extended-release form to release tramadol too quickly, dangerously raising drug levels and increasing the risk of fatal overdose. Avoid alcohol entirely.
• Drugs that lower the seizure threshold: Certain antidepressants, antipsychotics, and other medicines may raise the risk of seizures when combined with tramadol.
• CYP2D6 inhibitors: Drugs such as certain antidepressants (for example, fluoxetine, paroxetine) may change how tramadol is converted to its active form, affecting pain relief and side effects.
• CYP3A4 inhibitors and inducers: Inhibitors such as certain antifungals and macrolide antibiotics may raise tramadol levels, while inducers such as rifampin, carbamazepine, and phenytoin may lower its effectiveness.
• Mixed agonist/antagonist and partial agonist opioids: Drugs such as buprenorphine, nalbuphine, or pentazocine may reduce the pain-relieving effect and may trigger withdrawal.
• Anticholinergic drugs: May increase the risk of severe constipation, urinary retention, or bowel obstruction.
• Digoxin and warfarin: Tramadol may affect the levels or effects of these medicines. Your provider may monitor you more closely.

Monitoring Requirements

Your healthcare provider may monitor:

• Signs of respiratory depression and sedation, especially early in treatment and after dose increases
• Signs of seizures, particularly at higher doses or with other seizure-lowering medicines
• Signs of serotonin syndrome, particularly when combined with serotonergic medicines
• New or worsening mood, behavior, or thoughts of self-harm
• Your pain relief and overall response to treatment
• Your risk for abuse, misuse, and diversion throughout treatment
• Blood pressure, particularly in patients at risk for low blood pressure
• Bowel function, given the risk of constipation
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Tramadol is a Schedule IV controlled substance.

• Although tramadol was once thought to have a low abuse potential, it can be misused, abused, and diverted, and it may be a target for people who abuse prescription medicines.
• Physical dependence and tolerance can develop with continued use. Physical dependence is not the same as addiction, but it means you should not stop suddenly.
• Do not increase your dose on your own.
• Do not sell or give away tramadol. Doing so may harm others and is against the law. Even a single dose can be fatal to someone who is not opioid-tolerant, especially a child.
• Misusing this medication, including crushing, snorting, or injecting it or taking it in ways other than prescribed, can cause overdose and death.

Long-Term Use Considerations

• If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
• Physical dependence and tolerance are expected with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Long-term opioid use may affect hormone levels, leading to symptoms such as low energy, reduced sex drive, or menstrual changes. Tell your provider if these occur.
• Ongoing constipation is common with continued use and may require a management plan from your provider.

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Patient Counseling Information

Safe Medication Use

• Take tramadol exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Do not exceed the maximum daily dose set by your provider, since higher doses raise the risk of seizures.
• Swallow extended-release tablets and capsules whole. Never crush, chew, break, or dissolve them, as this can release a fatal dose all at once.
• Take extended-release forms on a regular schedule. They are not for as-needed pain relief.
• Do not stop taking tramadol suddenly after prolonged use. Talk to your healthcare provider about a safe tapering plan.
• Do not share tramadol with anyone else. Sharing is dangerous and against the law.
• Keep tramadol in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Seizure and serotonin syndrome risk: Tell your provider about all medicines you take, especially antidepressants, other opioids, and medicines that affect serotonin or lower the seizure threshold. Watch for signs of serotonin syndrome, such as agitation, fast heartbeat, fever, or muscle stiffness, and get help right away if they occur.
• MAOIs: Never take tramadol within 14 days of an MAOI.
• Benzodiazepines, alcohol, and CNS depressants: Do not use these with tramadol unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking tramadol. Alcohol can cause the extended-release form to release the drug too quickly, leading to a fatal overdose.
• Driving and machinery: Tramadol can make you sleepy or dizzy and can slow your thinking and reaction time. Do not drive or operate heavy machinery until you know how it affects you.
• Naloxone preparedness: Ask your provider about naloxone, a medicine that can reverse an opioid overdose. Make sure family members or caregivers know how to recognize an overdose and use naloxone. Because tramadol is long-acting in its extended-release form, more than one dose of naloxone may be needed.
• Mental health: Tell your provider about any new or worsening depression or thoughts of self-harm.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant, as prolonged use can cause neonatal opioid withdrawal syndrome in your baby.
• Breastfeeding: Tramadol can pass into breast milk and may cause serious harm to a nursing baby, including breathing problems. Talk to your provider before breastfeeding while taking tramadol.
• Constipation: Ask your provider about ways to prevent or manage constipation while taking tramadol.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or stopped breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Have a seizure
• Develop signs of serotonin syndrome, such as agitation, hallucinations, fast heartbeat, fever, or muscle stiffness
• Have new or worsening depression or thoughts of harming yourself
• Have a severe allergic reaction, such as swelling of the face or throat, hives, or trouble breathing
• Feel faint, very dizzy, or lightheaded
• Develop signs of adrenal problems, such as ongoing nausea, vomiting, loss of appetite, or severe weakness
• Have severe constipation, stomach pain, or are unable to have a bowel movement
• Experience withdrawal symptoms such as restlessness, sweating, muscle aches, nausea, or diarrhea after reducing or stopping the medication
• Have any symptom that concerns you or does not go away