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Commonly reported side effects of tramadol include: pruritus, agitation, anxiety, constipation, diarrhea, hallucination, nausea, tremor, vomiting, and diaphoresis. Other side effects include: insomnia. See below for a comprehensive list of adverse effects.
Applies to tramadol: oral capsule extended release, oral suspension, oral tablet, oral tablet extended release
Oral route (Tablet; Tablet, Extended Release; Capsule, Extended Release)
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.
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.
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 of even one dose of tramadol hydrochloride, especially by children, can result in a fatal overdose of tramadol.
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.
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.
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.
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 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:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking tramadol:
Symptoms of overdose
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:
Applies to tramadol: oral capsule extended release, oral tablet, oral tablet disintegrating, oral tablet extended release
The most common adverse reactions include nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.
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).
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
Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, angioneurotic edema, swollen skin
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
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.
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
Postmarketing reports: Serotonin syndrome
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
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
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.
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
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
Common (1% to 10%): Anorexia, decreased weight, increased blood glucose
Uncommon (0.1% to 1%): Gout
Rare (less than 0.1%): Changes in appetite
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion
Postmarketing reports: Adrenal insufficiency; androgen deficiency
Uncommon (0.1% to 1%): Anemia, ecchymosis
Uncommon (0.1% to 1%): Cholelithiasis, cholecystitis, ALT and AST increased, abnormal liver function tests
Common (1% to 10%): Miosis, visual disturbance, blurred vision
Uncommon (0.1% to 1%): Lacrimation disorder
Frequency not reported: Mydriasis
Uncommon (0.1% to 1%): blood urea nitrogen increased
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
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