Tramadol

DEA Class; Rx

Common Brand Names; Ultram, ConZip, Qdolo

Oral opioid analgesic
Used for the treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Associated with risk for seizures and suicidal tendency

Indicated for moderate-to-severe pain management in adults which alternative therapies are inadequate

Initiate dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse

Hypersensitivity to tramadol or opioids

Known or suspected gastrointestinal obstruction, including paralytic ileus

Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within last 14 days

Children <12 years

Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy

Severe/acute bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

Significant respiratory depression

Immediate release

• Constipation (24-46%)

• Nausea (24-40%)

• Dizziness/vertigo (26-33%)

• Headache (18-32%)

• Somnolence (16-25%)

• Vomiting (9-17%)

• CNS stimulation (7-14%)

• Dyspepsia (5-13%)

• Asthenia (6-12%)

• Pruritus (8-11%)

Extended release

• Nausea (5.7-25.1%)

• Headache (19-23.1%)

• Constipation (4.2-21.3%)

• Somnolence (4-16.1%)

• Dizziness (4.8-13.6%)

• Dry mouth (3.4-13.1%)

• Vomiting (1.9-10.4%)

Contains a Schedule IV controlled substance; exposes users to risks of addiction, abuse, and misuse

Serotonin syndrome may occur; may be life-threatening; may occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol

Serious, life-threatening, or fatal respiratory depression has been reported; also occurred in children treated with tramadol

Opioids can cause sleep-related breathing disorders including central sleep apnea and sleep-related hypoxemia

Prolonged use during pregnancy can result in withdrawal in the neonate

Seizures have been reported; spontaneous postmarketing reports indicate that seizure risk is increased with doses

May increase the risk of suicide

Cases of adrenal insufficiency have been reported with opioid use, more often following >1 month of use; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids

May cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; monitor for signs of hypotension after initiating or titrating

May impair mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery; advise not to drive or operate dangerous machinery unless tolerant to effects and aware of reaction to medication

Spasm of the sphincter of Oddi reported; opioids may cause increases in serum amylase; monitor with biliary tract disease, including acute pancreatitis for worsening symptoms

Serious and rarely fatal anaphylactic reactions have been reported

Cases of tramadol-associated hypoglycemia reported; some resulting in hospitalization; in most cases, patients had predisposing risk factors (eg, diabetes); if hypoglycemia suspected, monitor blood glucose levels and consider drug discontinuation as appropriate

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome

Tramadol and its active metabolite, O-desmethyltramadol (M1), are present in human milk