Nebido Adverse Reactions

Summary of the safety profile: Regarding undesirable effects associated with the use of androgens, please also refer to Precautions.
The most frequently reported undesirable effects during treatment with Testosterone undecanoate (Nebido) are acne and injection site pain.
The table as follows reports adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs, version 10.1)* reported with Testosterone undecanoate (Nebido). The frequencies are based on clinical trial data and defined as Common (≥1/100 to <1/10) and Uncommon (≥1/1000 to <1/100). The ADRs were recorded in 6 clinical studies (N=422) and considered at least possibly causally related to Testosterone undecanoate (Nebido).
Tabulated list of adverse reactions: See table.

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Description of selected adverse reactions: Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhydrosis, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported rarely in clinical trials (in ≥1/10,000 and <1/1,000 injections) as well as from postmarketing experience (see Precautions).
Suspected anaphylactic reactions after Testosterone undecanoate (Nebido) injection have been reported.
In addition to the previously mentioned adverse reactions, nervousness, hostility, sleep apnea, various skin reactions including seborrhoea, increased hair growth, increased frequency of erections and in very rare cases jaundice have been reported under treatment with testosterone containing preparations.
Therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and edema.