Drug products: Dolatramyl, Gemadol, Nobligan®, Nobligan® retard, Tiparol®, Tiparol® OD, Tiparol® Retard, Tradolan®, Tradolan® Retard, Tramadol 2care4, Tramadol Actavis, Tramadol Alternova, Tramadol Aurobindo, Tramadol HEXAL, Tramadol Krka, Tramadol Retard Actavis, Tramadol Retard Hexal, Tramadol Retard Krka, Tramadol Retard Medartuum, Tramadol Retard Mylan, Tramadol STADA®, Tramadol Vitabalans, Tramuno, Zaldiar
ATC code: N02AJ13, N02AX02
Substances: tramadol, tramadol hydrochloride
Studies show similar effect of tramadol on pain relief in men and women. In an observational study on patients undergoing laparoscopic cholecystectomy, women and men reported the same pain level before tramadol injection. Women reported more pain and received a higher mean dose tramadol during the first postoperative hour. However, the decrease in pain was similar between men and women after 30 minutes.
Tramadol-induced seizures are dose-dependent in a similar way in men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
The literature indicates that women and men differ in pain behavior. This could be influenced by differences in pharmacokinetics, sex hormones, differences in stress response, or type of pain test. Also, many variables other than a person’s sex/gender account for individual differences in pain sensitivity. The prevalence of several clinical pain conditions are higher in women than men suggests that either different clinical pain mechanisms may operate in men vs. women, or different or additional risk factors are relevant in one sex, or a combination of differences .
A study in healthy Iranian volunteers (12 men, 12 women) showed no differences in pharmacokinetics of a single dose of 100 mg tramadol . The original manufacturer reports that dose-normalized AUC values for tramadol are higher in healthy women than men, but that the results shows considerable overlap in AUC values between men and women. The scientific data backing this statement has not been presented .
In a prospective observational study in patients undergoing laparoscopic cholecystectomy (60 men, 60 women), mean dose of tramadol was higher in women during the first postoperative hour in order to achieve a similar degree of analgesia (40 mg vs. 27.8 mg). Baseline pain score was similar in men and women. The difference in doses was not significant during the later period . The original manufacturer recommends no dosage adjustment based on sex .
The effect of sex on pain perception has been analyzed in a prospective observational study in patients after laparoscopic cholecystectomy (60 men, 60 women). Patients assessed postoperative pain based on a numerical rating score and also indicated the degree of pain improvement after receiving tramadol 10 mg i.v. Baseline pain score was similar in men and women. Women expressed more pain at 20 and 30 min after first tramadol administration and required more tramadol during the first postoperative hour (see Pharmacokinetics and dosing). The decrease in pain was similar in men and women after 30 min postoperatively .A randomized, placebo-controlled trial (63 men, 167 women) showed that the analgesic effect of 200 mg tramadol once daily for osteoarthritis was similar in men and women .
No studies on differences between men and women using therapeutic recommended doses have been found. There is a risk of seizure when using high doses of tramadol in both men and women (see Other information).
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
There is a risk of seizure when using high doses of tramadol . An observational study (112 men, 23 women) analyzed the relation between seizure and tramadol intoxication in Iranian patients with a history of tramadol overdose and experience of seizure or loss of consciousness. Seizures correlated with higher reported doses in a similar way in men and women . Another Iranian study (197 men, 35 women), retrospectively analyzed the prevalence, type and site of injuries due to tramadol-induced seizures. The prevalence of trauma was 24.6% and the occurrence of trauma was independent of sex .
Date of litterature search: 2015-02-23
Reviewed by: Mia von Euler, Karin Schenck-Gustafsson
Approved by: Karin Schenck-Gustafsson