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Ultram ER Side Effects

Generic Name: tramadol

Note: This document contains side effect information about tramadol. Some of the dosage forms listed on this page may not apply to the brand name Ultram ER.

In Summary

Common side effects of Ultram ER include: nausea and vomiting. Other side effects include: insomnia, pruritus, and diaphoresis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tramadol: oral capsule extended release, oral suspension, oral tablet, oral tablet extended release

Warning

Oral route (Tablet; Tablet, Extended Release; Capsule, Extended Release)

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.

Along with its needed effects, tramadol (the active ingredient contained in Ultram ER) 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

  • 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 from a lying or sitting position
  • fainting
  • fast heartbeat
  • frequent urge to urinate
  • gaseous abdominal or 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
  • confusion
  • cough
  • darkening of the skin
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fever
  • hives, itching, skin rash
  • irregular heartbeat, recurrent
  • loss of appetite
  • mental depression
  • nausea
  • overactive reflexes
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • shivering
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • 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

  • Change in consciousness
  • decreased awareness or responsiveness
  • difficulty with breathing
  • lack of muscle tone
  • lightheadedness
  • loss of consciousness
  • pinpointed pupils of the eyes
  • severe sleepiness
  • slow or irregular heartbeat
  • unusual tiredness

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

  • Constipation
  • discouragement
  • drowsiness
  • dry mouth
  • feeling of warmth
  • feeling sad or empty
  • feeling unusually cold
  • general feeling of discomfort or illness
  • headache
  • 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

  • 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 aching or cramping
  • muscle injury
  • muscle pain, stiffness, spasms, or twitching
  • nasal congestion
  • 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 with sleeping
  • weight increased or decreased

For Healthcare Professionals

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

General

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]

Very common (10% or more): CNS stimulation (up to 14%)

Common (1% to 10%): Anxiety, euphoria, nervousness, sleep disorder, insomnia, depression, agitation, apathy, depersonalization

Uncommon (0.1% to 1%): Emotional lability

Rare (less than 0.1%): Hallucinations, nightmares, dependency

Very rare (less than 0.01%): Withdrawal syndrome[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, angioneurotic edema, swollen skin[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 40%), constipation (up to 46%), vomiting (up to 17%), dyspepsia (up to 13%)

Common (1% to 10%): Dry mouth, diarrhea, abdominal pain, flatulence, sore throat, gastroenteritis viral

Uncommon (0.1% to 1%): Toothache, appendicitis, pancreatitis[Ref]

Nervous system

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]

Very common (10% or more): Dizziness (up to 28%), somnolence (up to 25%), headache (up to 32%),

Common (1% to 10%): Confusion, coordination disturbance, tremor, paresthesia, hypoesthesia

Uncommon (0.1% to 1%): Migraine, sedation, syncope, disturbance in attention

Rare (less than 0.1%): Epileptiform seizures

Postmarketing reports: Seizures

Opioids:

Postmarketing reports: Serotonin syndrome[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 11%)

Common (1% to 10%): Sweating, rash, dermatitis

Uncommon (0.1% to 1%): Cellulitis, piloerection, clamminess, urticaria, toxic epidermal necrolysis, Stevens Johnson-syndrome, hair disorder, skin disorder[Ref]

Genitourinary

Common (1% to 10%): Menopausal symptoms, urinary frequency, urinary retention, urinary tract infection

Uncommon (0.1% to 1%): Difficulty in micturition, hematuria, dysuria, cystitis, sexual function abnormality[Ref]

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]

Very common (10% or more): Flushing (up to 15.8%)

Common (1% to 10%): Vasodilation, postural hypotension, chest pain

Uncommon (0.1% to 1%): Palpitations, myocardial infarction, lower limb edema, peripheral swelling, hypertension, increased heart rate, peripheral ischemia, EKG abnormality, hypotension, tachycardia

Rare (less than 0.1%): Bradycardia

Postmarketing reports: QT prolongation/torsade de pointes[Ref]

Other

Very common (10% or more): Asthenia (up to 12%)

Common (1% to 10%): Malaise, weakness, pain, feeling hot, influenza like illness, rigors, lethargy, pyrexia

Uncommon (0.1% to 1%): Tinnitus, vertigo, ear infection[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased weight, increased blood glucose

Uncommon (0.1% to 1%): Gout

Rare (less than 0.1%): Changes in appetite[Ref]

Endocrine

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion

Opioids:

Postmarketing reports: Adrenal insufficiency; androgen deficiency[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis[Ref]

Hepatic

Uncommon (0.1% to 1%): Cholelithiasis, cholecystitis, ALT and AST increased, abnormal liver function tests[Ref]

Ocular

Common (1% to 10%): Miosis, visual disturbance, blurred vision

Uncommon (0.1% to 1%): Lacrimation disorder

Frequency not reported: Mydriasis[Ref]

Renal

Uncommon (0.1% to 1%): blood urea nitrogen increased[Ref]

Musculoskeletal

Common (1% to 10%): Hypertonia, arthralgia, back pain, limb pain, neck pain, muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, aggravated osteoarthritis

Uncommon (0.1% to 1%): Joint swelling, joint sprain, muscle injury, leg cramps

Rare (less than 0.1%): Involuntary muscle contractions[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Ultram ER (traMADol)." PriCara Pharmaceuticals, Raritan, NJ.

4. "Product Information. Ultram (tramadol)." McNeil Pharmaceutical, Raritan, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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