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Striant

Last reviewed on RxList: 9/4/2019
Striant Side Effects Center

Last reviewed on RxList 9/4/2019

Striant (testosterone) buccal system is an androgen, a naturally occurring male sex hormone, used to treat men with low testosterone levels. Side effects of Striant in the mouth and gums may occur, including;

  • redness,
  • irritation,
  • pain,
  • tenderness,
  • swelling,
  • and
  • bitter/strange/change in taste

These effects usually go away within several days but may last up to 2 weeks. Other side effects of Striant include:

The recommended dosing schedule for Striant is the application of one buccal system (30 mg) to the gum region twice daily, morning and evening (about 12 hours apart). It should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). Striant may interact with warfarin, insulin or oral diabetes medications, propranolol, or corticosteroids. Tell your doctor all medications and supplements you use. This medication is not usually used in women, and is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have questions.

Our Striant (testosterone) 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
Striant Consumer Information

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

Call your doctor at once if you have:

  • severe gum or mouth irritation;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • breathing problems during sleep;
  • chest pain or pressure, pain spreading to your jaw or shoulder;
  • prostate symptoms--increased urination (especially at night), loss of bladder control, very little urine or a weak stream of urine;
  • 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:

  • pain, swelling, or tenderness of your gums;
  • headache;
  • more frequent or prolonged erections;
  • altered sense of taste; or
  • bitter or unpleasant taste in the mouth.

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 Striant (Testosterone)

QUESTION

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

SIDE EFFECTS

Clinical Trials Experience

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

Twelve Week Clinical Trials in Hypogonadal Men

In the Phase 3, open-label study, 98 patients received Striant for up to 12 weeks. Adverse reactions to Striant reported by ≥ 1% of patients are listed in Table 1.

Table 1: Adverse Reactions Observed With the Use of Striant in ≥ 1% of Patients

Adverse Reaction Striant
(n=98)
Gum or Mouth Irritation 9.2%
Taste Bitter 4.1%
Gum Pain 3.1%
Gum Tenderness 3.1%
Headache 3.1%
Gum Edema 2.0%
Taste Perversion 2.0%

Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days [see Gum-related adverse events and gum examinations in Adverse Reactions].

The following adverse reactions to Striant occurred in 1 patient each: acne, anxiety, breast enlargement, breast pain, buccal mucosal roughening, difficulty in micturition, fatigue, gingivitis, gum blister, gustatory sense diminished, hematocrit increased, lipids serum increased, liver function tests abnormal, nose edema, stinging of lips, and toothache.

There was one additional 12-week study in 12 patients. In this study, additional adverse reactions to Striant and reported by 1 patient each included emotional lability and hypertension.

Long-Term Extension Clinical Trials in Hypogonadal Men

In two extension trials, a total of 117 and 51 patients received Striant for at least 6 months and 1 year, respectively.

Of 117 patients treated for at least 6 months, adverse reactions reported by 1 patient each included: anxiety, buccal inflammation, depression, dry mouth, gum redness, hypertension, infection, medication error, nausea, pruritus, renal function abnormal, stomatitis, taste bitter, taste perversion and toothache. Polycythemia and increased serum prostate specific antigen (PSA) were reported in three and two patients, respectively.

In these two extension studies, a total of 48 patients received Striant for at least 2 years. In these patients, adverse reactions included: gingival recession, lip ulceration, stomatitis, rash, prostate cancer, increased PSA, abdominal pain, diarrhea, hypertension aggravated, headache, nervousness, polycythemia, taste perversion, aggressiveness, hyperlipidemia, peripheral edema, and anxiety.

Gum-related Adverse Events And Gum Examinations

In the open-label study, all reported gum-related adverse events were collected and gum examinations were conducted at Baseline and every month thereafter.

A total of 16 patients reported 19 gum-related adverse reactions. Of these, ten patients (10.2%) reported 12 reactions of mild intensity, four patients (4.1%) reported 5 reactions of moderate intensity, and two patients (2.0%) reported 2 reactions of severe intensity. Four patients (4.1%) discontinued treatment with Striant due to gum or mouth-related adverse reactions including two with severe gum irritation, one with mouth irritation, and one with “bad taste in mouth.” Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.

Monthly gum examinations were conducted to assess for gingivitis, gum edema, oral lesions, ulcerations or leukoplakia. No cases of ulceration or leukoplakia were observed. No new oral lesions were observed. The incidence of gingivitis and gum edema was not increased during treatment.

In the two extension trials, gum examinations were conducted every 3 months while on treatment. In one of these trials, no patient had a gum abnormality, and in the other trial, moderate gingivitis and mild gum edema were reported by 1 patient each.

In these two extension studies, patient-reported information on Striant gum adherence was collected every 3 months for 1 year. At each visit, 37% to 52% of patients reported problems with Striant adhering to the gum. Circumstances surrounding Striant detachment included eating, drinking and oral care. Hot foods and hot beverages were more likely to be associated with detachment than cold food and cold beverages.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Striant. 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: dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis, red blood cell increased, dysgeusia, venous thromboembolism, myocardial infarction, and stroke.

Read the entire FDA prescribing information for Striant (Testosterone)

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

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