Natesto

Natesto Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Natesto (testosterone) nasal gel is testosterone, an androgen, used for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary or hypogonadotropic hypogonadism (congenital or acquired). Common side effects include increased prostate specific antigen (PSA), headache, runny nose, nosebleed, nasal discomfort, nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, and nasal scab.

The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations; 1 actuation per nostril) administered intranasally three times daily for a total daily dose of 33 mg. Natesto may interact with insulin, oral anticoagulants, corticosteroids, and oxymetazoline. Tell your doctor all medications and supplements you use. Natesto is not recommended for use in women, therefore it is unlikely to be used while pregnant or breastfeeding. Anabolic steroids, such as testosterone, are often abused. Abuse is often associated with adverse physical and psychological effects. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Natesto (testosterone) nasal gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Natesto FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Natesto was evaluated in a multicenter, open-label, 90-day clinical study. Patients could continue treatment with Natesto in two, open-label extension periods for an additional 90 and 180 days, respectively. A total of 306 hypogonadal men with morning testosterone concentrations ≤ 300 ng/dL received Natesto. Of these, 78 received Natesto at a dose of 11 mg three times daily.

90-Day Clinical Study

Among the 78 patients who received Natesto three times daily in the 90-day clinical study, the most common adverse reactions were: prostate specific antigen (PSA) increased, headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, upper respiratory tract infection (URI), sinusitis, bronchitis and nasal scab. PSA increased was considered an adverse reaction by meeting one of two pre-specified criteria: (1) increase from baseline serum PSA greater than 1.4 ug/L, or (2) serum PSA greater than 4.0 ug/L.

Table 1 shows adverse reactions reported by ≥ 3% of patients treated with 11 mg three times daily in the 90-day clinical study.

Table 1: Adverse Reactions Reported by ≥ 3% of Patients Treated with Natesto (11 mg of testosterone) Three Times Daily in the 90-Day Clinical Study

Adverse Reactions Natesto (11 mg of Testosterone) Three Times Daily
(N=78)
n (%)
PSA increased 4 (5.1)
Headache 3 (3.8)
Rhinorrhea 3 (3.8)
Epistaxis 3 (3.8)
Nasal discomfort 3 (3.8)
Nasopharyngitis 3 (3.8)
Bronchitis 3 (3.8)
Upper respiratory tract infection 3 (3.8)
Sinusitis 3 (3.8)
Nasal scab 3 (3.8)

Adverse reactions reported by > 2% but < 3% of patients in the 90-day clinical study include: blood pressure increased, dysgeusia, nasal dryness, nasal congestion, and cough.

Extension Periods

Among the 78 patients who received Natesto three times daily in the 90-day clinical study, a total of 69 patients received Natesto three times daily in the first 90-day extension period. Among these 69 patients, the most common adverse reactions were: nasopharyngitis, PSA increased, parosmia, nasal discomfort, rhinorrhea and nasal scab.

Table 2 shows adverse reactions reported by ≥ 3% of patients who received Natesto three times daily in both the 90-day clinical study and in the 90-day extension period.

Table 2: Adverse Reactions Reported by ≥ 3% of Patients in Both the 90-Day Clinical Study and in the 90-Day Extension Period

Adverse Reactions Natesto 11 mg TID
(N=69)
n (%)
Nasopharyngitis 6 (8.7)
Rhinorrhea 5 (7.2)
PSA increased 4 (5.8)
Parosmia 4 (5.8)
Nasal discomfort 4 (5.8)
Nasal Scab 4 (5.8)
Upper respiratory tract infection 3 (4.3)
Bronchitis 3 (4.3)
Procedural pain 3 (4.3)
Pain in extremity 3 (4.3)
Headache 3 (4.3)
Epistaxis 3 (4.3)

A total of 18 patients received Natesto three times daily in all three treatment periods, including the 90-day clinical study, the first 90-day extension period, and the second 180-day extension period. Among these 18 patients, the following adverse reactions were reported in more than one patient each: nasopharyngitis, parosmia, PSA increased, nasal discomfort, nasal scab and hypertension. The following adverse reactions were reported in one patient each: nausea, nasal excoriation, thyroid stimulating hormone increased, decreased appetite, myalgia, anosmia, testicular atrophy, epistaxis, nasal septum disorder, nasal discomfort, and rhinorrhea.

In patients who received Natesto three times daily, mean serum PSA concentrations increased by 0.2 ng/mL, 0.1 ng/mL, and 0.2 ng/mL after 90, 180 and 360 days, respectively.

Discontinuations due to Adverse Reactions

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90-and 180-day extension periods, a total of 6 subjects withdrew from treatment for the following adverse reactions, reported by 1 subject each: nasal discomfort, headache, dysgeusia, PSA increased, allergic reaction (hives, swollen lips and tongue), and 1 patient with myalgia, arthralgia, fever, chills and petechiae.

Increased Hematocrit

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90-and 180-day extension periods, a total of 4 subjects had a hematocrit level > 55%. These 4 patients had baseline hematocrits of 48% and 51%. In no case did hematocrit exceed 58%.

Nasal Adverse Reactions

Among all subjects (n=306) who received Natesto at any dose in the 90-day clinical study and its 90-and 180-day extension periods, the following nasal adverse reactions were reported: nasopharyngitis (8.2%), rhinorrhea (7.8%), epistaxis (6.5%), nasal discomfort (5.9%), parosmia (5.2%), nasal scab (5.2%), upper respiratory infection (4.2%), nasal dryness (4.2%), and nasal congestion (3.9%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of testosterone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Vascular Disorders: Venous thromboembolism [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Natesto (Testosterone Nasal Gel) »

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