Reported Adverse Drug Reaction Cases
- Edronax, Australian Product Information, Pharmacia Australia Pty Ltd. 1 Sep 2004
- McEwen J. Meyboom RH. Testicular pain caused by mazindol. Brit Med J 1983;287:1763-4.
Genitourinary symptoms with reboxetine
Reboxetine (Edronax) is a selective noradrenaline reuptake inhibitor for the treatment of major depression. ADRAC has received 130 reports concerning reboxetine. Genitourinary problems, occurring within 5 weeks of commencing therapy, were described in 41 reports.
In 26 reports patients developed urinary symptoms consistent with obstruction including hesitancy, reduced urine flow, retention, and dribbling post micturition. All but 6 of the patients were male. During short-term clinical trials, urinary retention was reported in 3% of patients and impaired urination in 4.6%.1
ADRAC has also received 22 reports of male sexual dysfunction including ejaculation disorder (7 reports), erectile dysfunction (4) and pain or swelling of the testicles or external genitalia (10).
Two additional reports were of increased libido in women. In short term clinical trials, abnormalities of sexual function and impotence were reported in 1.3% and 1.6% of patients, respectively.1 Testicular pain is a very unusual adverse reaction. It has also been associated with mazindol (Sanorex) an anorectic drug no longer marketed in Australia which has a similar structure to reboxetine.2
Patients prescribed reboxetine should be asked about symptoms of urinary obstruction and sexual dysfunction soon after commencing therapy.Reference
Australian Adverse Drug Reactions Bulletin
Volume 24, Number 3, June 2005