Natesto

Last reviewed on RxList: 8/10/2020
Natesto Side Effects Center

What Is Natesto?

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).

What Are Side Effects of Natesto?

Common side effects of Natesto include increased prostate specific antigen (PSA), headache, runny or stuffy nose, nosebleed, nasal discomfort, upper respiratory tract infection, sinusitis, bronchitis, and nasal scab.

Dosage for Natesto

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.

What Drugs, Substances, or Supplements Interact with Natesto?

Natesto may interact with insulin, oral anticoagulants, corticosteroids, and oxymetazoline. Tell your doctor all medications and supplements you use.

Natesto During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Low Testosterone (Low T) Treatments See Slideshow
Natesto Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using testosterone nasal and call your doctor at once if you have:

  • increased urination (many times per day), loss of bladder control;
  • painful or difficult urination;
  • swelling, rapid weight gain, shortness of breath during sleep;
  • breast pain or swelling;
  • chest pain or pressure, pain spreading to your jaw or shoulder;
  • painful or bothersome erections;
  • nasal problems--runny or stuffy nose, sneezing, nosebleed, nose pain or dryness, scabs inside or around your nose;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • nasal problems;
  • sore throat; or
  • headache.

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.

Read the entire detailed patient monograph for Natesto (Testosterone Nasal Gel)

QUESTION

Testosterone is a chemical found only in men. See Answer
Natesto Professional Information

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 ReactionsNatesto
(11 mg of Testosterone) Three Times Daily
(N=78)
n (%)
PSA increased4 (5.1)
Headache3 (3.8)
Rhinorrhea3 (3.8)
Epistaxis3 (3.8)
Nasal discomfort3 (3.8)
Nasopharyngitis3 (3.8)
Bronchitis3 (3.8)
Upper respiratory tract infection3 (3.8)
Sinusitis3 (3.8)
Nasal scab3 (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 ReactionsNatesto 11 mg TID
(N=69)
n (%)
Nasopharyngitis6 (8.7)
Rhinorrhea5 (7.2)
PSA increased4 (5.8)
Parosmia4 (5.8)
Nasal discomfort4 (5.8)
Nasal Scab4 (5.8)
Upper respiratory tract infection3 (4.3)
Bronchitis3 (4.3)
Procedural pain3 (4.3)
Pain in extremity3 (4.3)
Headache3 (4.3)
Epistaxis3 (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.

Cardiovascular Disorders: myocardial infarction, stroke [see WARNINGS AND PRECAUTION]

Vascular Disorders: Venous thromboembolism [see WARNINGS AND PRECAUTION]

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

© Natesto Patient Information is supplied by Cerner Multum, Inc. and Natesto Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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