TRAUMEEL® PRODUCT MONOGRAPH58

Similar to the above drug surveillance studies, surveillance in 1,359 patients treated with oral forms of Traumeel® found that Traumeel® was well tolerated and no adverse reactions were observed.[Zenner 1997]

Observational studies comparing Traumeel® with conventional treatments for musculoskeletal injury show that the tolerability of Traumeel® is significantly greater compared with conventional treatment.[Birnesser 1994, Schneider 2008]

In an observational, non-randomized study comparing Traumeel® injection (n=106) with NSAID injection (n=78; mainly diclofenac) in 184 patients with diagnosed epicondylitis over 2 weeks, both treatments were well tolerated.[Birnesser 1994] However, a significantly greater proportion of patients receiving Traumeel® reported very good tolerability compared with those receiving NSAIDs (88% versus 45%, respectively). Indeed, only three adverse events were reported during the study, all in the NSAID group.

A prospective, observational cohort study compared 69 patients treated with Traumeel® with 64 conventionally treated patients with various musculoskeletal injuries followed over a maximum of 3 months.[Schneider 2008] Tolerability was judged by physicians to be very good in a significantly greater proportion of patients receiving Traumeel® compared with conventional treatment (90% versus 50%; p=0.001). Furthermore, there were no adverse events reported in the Traumeel® group, while 6 adverse events were reported with conventional therapy.

In MOZArT, the co-administration of Traumeel® and Zeel® T was safe and very well tolerated.[Lozada 2017]

SAFETY IN CHILDREN

Data in children are limited to one study conducted in 157 children aged 0 12 years, median age 10 years.[Ludwig 2001] The use of Traumeel® ointment was rated as having excellent or good tolerability in all patients by reporting pediatricians. No adverse effects were reported from the use of Traumeel® ointment.

REPORTED ADVERSE EFFECTS

Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Tablets: In isolated cases transient skin reactions have been reported. Solution for Injection: In isolated cases transient allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) have been reported. Ointment: In isolated cases transient skin reactions have been reported. Gel: In isolated cases transient skin reactions (eg. rash, itchiness) have been reported. Drops: In isolated cases transient allergic skin reactions have been reported.