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Tramadol Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.

Applies to tramadol: oral capsule extended release, oral capsule extended release 24 hr, oral solution, oral suspension, oral tablet, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, extended release; capsule, extended release; solution)

Addiction, Abuse, and Misuse

TraMADol hydrochloride 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 traMADol hydrochloride, and monitor all patients regularly for the development of these behaviors or conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products.

Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of traMADol hydrochloride.

Monitor for respiratory depression, especially during initiation of traMADol hydrochloride or following a dose increase.

Instruct patients to swallow traMADol hydrochloride extended release formulations intact, and not to cut, break, chew, crush, or dissolve the tablets to avoid exposure to a potentially fatal dose of traMADol.

Accidental Ingestion

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

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

Life-threatening respiratory depression and death have occurred in children who received traMADol.

Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of traMADol due to a CYP2D6 polymorphism.

TraMADol hydrochloride tablets are 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 traMADol hydrochloride tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of traMADol.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of traMADol hydrochloride 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.

Interactions with Drug Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with traMADol are complex.

Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with traMADol hydrochloride requires careful consideration of the effects on the parent drug, traMADol, and the active metabolite, M1.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

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

Reserve concomitant prescribing of traMADol hydrochloride 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.

Precautions

It is very important that your doctor check your or your child's progress at regular visits, especially within the first 24 to 72 hours of treatment to make sure the medicine is working properly. 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) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

You should not take other medicines that also contain tramadol. This includes Conzip®, Qdolo, Ryzolt™, Ultram®, or Ultracet®. Using these medicines together may increase your chance for more serious side effects.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with tramadol may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product (O-desmethyltramadol) more quickly than others. These individuals are called "ultra-rapid metabolizers of tramadol". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of tramadol." As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:

If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine:

Check with your doctor right away if you or your child 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.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, unusual tiredness or weakness, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

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

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your doctor or dentist gives you certain medicines without knowing that you have been taking tramadol.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose. Signs of an overdose include: seizures, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or trouble breathing.

Do not change your dose or suddenly stop using this medicine without first 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, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

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.

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.

Common side effects of tramadol

Some side effects of tramadol 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 side effects

  • constipation
  • discouragement
  • drowsiness
  • dry mouth
  • feeling of warmth
  • feeling sad or empty
  • feeling unusually cold
  • general feeling of discomfort or illness
  • heartburn
  • irritability
  • itching or skin rash
  • joint pain
  • loss of interest or pleasure
  • loss of strength or weakness
  • muscle aches and pains
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • sleepiness or unusual drowsiness
  • sore throat
  • stomach pain
  • stuffy nose
  • tiredness
  • trouble concentrating
  • unusual feeling of excitement
  • weakness

Less common side effects

  • abnormal dreams
  • appetite decreased
  • back pain
  • bladder pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody or cloudy urine
  • body aches or pain
  • change in hearing
  • clamminess
  • cough producing mucus
  • cracked, dry, or scaly skin
  • decreased interest in sexual intercourse
  • difficult, burning, or painful urination
  • difficulty with moving
  • disturbance in attention
  • ear congestion
  • ear drainage
  • earache or pain in the ear
  • excessive gas
  • falls
  • false or unusual sense of well-being
  • feeling hot
  • feeling jittery
  • general feeling of bodily discomfort
  • goosebumps
  • headache, severe and throbbing
  • hoarseness
  • inability to have or keep an erection
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • joint sprain, stiffness, or swelling
  • loss in sexual ability, desire, drive, or performance
  • loss of voice
  • lower back or side pain
  • muscle injury, stiffness, spasms, or twitching
  • neck pain
  • night sweats
  • pain in the limbs
  • pain or tenderness around the eyes and cheekbones
  • pain, swelling, or redness in the joints
  • skin discoloration
  • trouble in holding or releasing urine
  • trouble sleeping
  • weight changes

Serious side effects of tramadol

Along with its needed effects, tramadol 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 while taking tramadol:

Less common side effects

  • abnormal or decreased touch sensation
  • blisters under the skin
  • bloating
  • blood in the urine
  • blood pressure increased
  • blurred vision
  • change in walking and balance
  • chest pain or discomfort
  • chills
  • dark urine
  • difficult urination
  • dizziness or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast heartbeat
  • frequent urge to urinate
  • gaseous stomach pain
  • indigestion
  • irregular heartbeat
  • loss of memory
  • numbness and tingling of the face, fingers, or toes
  • pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale, bluish-colored or cold hands or feet
  • recurrent fever
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe cramping
  • severe nausea
  • severe redness, swelling, and itching of the skin
  • stomach fullness
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • trembling and shaking of the hands or feet
  • trouble performing routine tasks
  • weak or absent pulses in the legs
  • yellow eyes or skin

Incidence not known

  • agitation
  • anxiety
  • chest tightness
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough
  • darkening of the skin
  • decreased urine output
  • depression
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fever
  • headache
  • hives, itching, skin rash
  • increased hunger
  • increased thirst
  • loss of appetite
  • mental depression
  • muscle cramps
  • nausea
  • nervousness
  • nightmares
  • overactive reflexes
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • shakiness
  • shivering
  • slurred speech
  • swelling of the face, ankles, or hands
  • talking or acting with excitement you cannot control
  • trouble breathing
  • twitching
  • unusual tiredness or weakness
  • vomiting

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

Symptoms of overdose

For healthcare professionals

Applies to tramadol: oral capsule extended release, oral liquid, oral tablet, oral tablet disintegrating, oral tablet extended release.

General adverse events

The most common adverse reactions include nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.[Ref]

Psychiatric

CNS stimulation has been reported as a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations. During clinical trials, tolerance development was mild and the reports of a withdrawal syndrome were rare. Symptoms of a withdrawal syndrome have included: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).[Ref]

Hypersensitivity

Gastrointestinal

Nervous system

Opioids:

Epileptiform seizures primarily occurred following administration of high doses or following concomitant treatment with drugs that lower the seizure threshold or trigger seizures.

Serotonin syndrome has been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Dermatologic

Genitourinary

Cardiovascular

Reports of QT prolongation and/or torsade de pointes have been received. In many cases, patients were taking another drug associated with QT prolongation, had risk factors for QT prolongation such as hypokalemia, or in the overdose setting.[Ref]

Other

Metabolic

Severe hyponatremia and/or SIADH have been reported, most often in females over 65 years old, and within the first week of therapy.[Ref]

Endocrine

Opioids:

Hematologic

Hepatic

Ocular

Renal

Musculoskeletal

See also:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2015) "Product Information. Ultram ER (tramadol)." PriCara Pharmaceuticals

4. (2001) "Product Information. Ultram (tramadol)." McNeil Pharmaceutical

Frequently asked questions

Further information

Tramadol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.