Tramadol Side Effects
- agitation
- anaphylactoid reactions
- anxiety
- asthenia
- confusion
- constipation
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dyspepsia
- emotional lability
- euphoria
- fetal death
- hallucinations
- headache
- hypertension
- hypotension
- increased urinary frequency
- insomnia
- lethargy
- nausea/vomiting
- neonatal abstinence syndrome
- physiological dependence
- pruritus
- rash (unspecified)
- respiratory depression
- seizures
- serotonin syndrome
- sinus tachycardia
- Stevens-Johnson syndrome
- tolerance
- toxic epidermal necrolysis
- tremor
- urinary retention
- urticaria
- vertigo
- visual impairment
- withdrawal
- xerostomia
Tramadol Adverse Reactions
The dose, route and duration of treatment affect the incidence of adverse effects associated with tramadol. Adverse effects are more likely associated with tramadol doses of 200 mg versus 50 or 100 mg and with intravenous as opposed to oral or intramuscular administration. The most common adverse reactions to tramadol are (incidence refers to 7 and 90 days of treatment, respectively) dizziness or vertigo (26%, 33%), nausea/vomiting (24%, 40% and 9%, 17%), constipation (24%, 46%), lethargy (16%, 25%), pruritus (8%. 11%), asthenia (6%, 12%), diaphoresis (sweating) (6%, 9%), dyspepsia (5%, 13%), xerostomia (dry mouth) (5%, 10%), and diarrhea (5%, 10%). Nausea, vomiting, and diaphoresis are more common after rapid IV infusion and to limit these effects, tramadol should be infused over 1 - 2 minutes. A slow oral dose titration (increasing tramadol by 50 mg every 3 days) has been associated with a decreased incidence of nausea and vomiting. Concomitant administration of an antiemetic during the first few days of tramadol therapy or with dosage increases may be beneficial. Tramadol is less likely to cause constipation than equipotent doses of acetaminophen and codeine. Tramadol does not have significant effects on the sphincter of Oddi.
Headache was reported in 18% and 32% of patients treated with tramadol for 7 and 90 days, respectively. Overuse of analgesics such as tramadol products by headache-prone patients frequently produces drug-induced rebound headache accompanied by dependence on symptomatic medication, tolerance (refractoriness to prophylactic medication), and withdrawal symptoms. In this case, overuse of tramadol products has been defined as taking 3 or more doses per day more often than 3 - 5 days per week. The frequency of use may be more important than the dose. Features of a rebound headache include morning headache, end-of-dosing interval headache, or headache improvement with discontinuation of overused medication. Stopping the symptomatic medication may result in a period of increased headache and then headache improvement. Analgesic overuse may be responsible for the transformation of episodic migraine or episodic tension headache into daily headache and may perpetuate the syndrome.
CNS stimulation consisting of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations has been reported in 7% of patients treated with tramadol for 7 days and in 14% of patients treated with tramadol for 90 days. Other CNS effects reported in 1 - 5% of patients include confusion, coordination disturbance, drowsiness, insomnia and visual impairment. Amnesia is reported in <1% of patients. Animal studies have implicated tramadol in seizure induction and seizures have been reported with tramadol use in humans. Seizures have ocurred at recommended doses as well as at high doses. Concomitant treatment with antidepressants, especially tricyclic antidepressants or SSRIs, or opiate agonists may increase the risk of seizures. Patients with an existing seizure disorder are most at risk. In a postmarketing surveillance case-control study (n=10,916) in the United Kingdom, patient exposure to tramadol alone at usual therapeutic dosages was not associated with an increased risk of idiopathic incident seizures. In overdose situations, tramadol ‘s neurotoxicity due to monoamine uptake inhibition appears to be a major problem as opposed to the opioid effects.
Some evidence of respiratory depression exists and the respiratory effects of tramadol have been compared to other opiate agonists. Tramadol produces less respiratory depression than morphine. At recommended doses of tramadol, respiratory depression is not likely to be significant. In tramadol overdose or in combination with anesthetic agents or ethanol, significant respiratory depression may occur. In a prospective case study of reports made to poison control centers of tramadol overdose, the lowest dose of tramadol associated with coma or respiratory depression was 800 mg.
Serious, but rarely fatal, anaphylactoid reactions have been reported in patients receiving tramadol. According to documented case reports on file with the manufacturer, patients with an allergy to codeine are at increased risk. Other allergic manifestations of tramadol include urticaria, rash (unspecified), Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Physiological dependence, tolerance and withdrawal reactions have been reported during tramadol therapy. Tramadol has also been associated with psychological dependence including drug craving and drug seeking behavior. Withdrawal reactions have been reported in patients receiving tramadol following naloxone administration. Tramadol can reinitiate physical dependence in patients who have been previously dependent or chronically taking opiate agonists. In patients with a tendency to drug abuse, a history of drug dependence, or who are taking chronic opiate agonists, treatment with tramadol is not recommended.
Urogenital effects reported in 1 - 5% of patients, that may be related to tramadol therapy include increased urinary frequency, urinary retention, and menopausal symptoms such as hot flashes.
The incidence of adverse cardiovascular events with tramadol is low. From 1 - 5% of patients developed vasodilatation and less than 1% of patients developed hypotension, orthostatic hypotension, or sinus tachycardia. In overdose situations, sinus tachycardia, agitation, confusion, and hypertension suggestive of a serotonin syndrome have been reported.
Neonatal abstinence syndrome, fetal death, and still birth have been reported with tramadol in post-marketing reports.
[ Last revised: 4/14/2003 3:58:00 PM ]
References
1784. Jick H, Derby LE, Vasilakis C et al. The risk of seizures associated with tramadol. Pharmacotherapy 1998;18:607-11.
2543. Kahn LH, Alderfer RJ, Graham DJ. Seizures reported with tramadol. JAMA 1997;278:1661.
2544. Spiller HA, Gorman SE, Villalobos D, et al. Prospective multicenter evaluation of tramadol exposure. J Toxicol Clin Toxicol 1997;35:361-4.
4043. Silberstein SD. Drug-induced headache. Neuro Clinic N America 1998;16:107-23.
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