Striant Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Striant (testosterone) buccal system is used to treat men with low testosterone levels. It is a naturally occurring male sex hormone. Side effects 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. Headache, nausea, acne, change in sexual interest, hair loss, toothache, or trouble sleeping may also occur.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Striant in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- nausea or vomiting;
- changes in skin color;
- swelling of the ankles or legs;
- breathing disturbances, including those associated with sleep;
- too frequent or prolonged erections;
- liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or
- dark colored urine or problems with urination.
Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience
- irritation or changes in the gum at the system application site;
- bitter or unusual taste in the mouth;
- emotional changes;
- increased blood pressure;
- decreased interest in sex;
- changes in blood cholesterol or number of red blood cells (detected by blood tests);
- prostate changes or difficulty urinating;
- enlarged, swollen or tender breasts; or
Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Striant (Testosterone) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Striant Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, anxiety), bleeding gums, mouth sores, trouble breathing (especially while sleeping), breast enlargement/pain.
Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea/vomiting, dark urine, yellowing of eyes/skin, stomach/abdominal pain, swelling of ankles/feet, sudden weight gain, trouble urinating, painful ejaculation, bloody semen, frequent pain/stiffness in lower back/hips/thighs, testicle pain/tenderness, change in size/shape of the testicles.
In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, fast heartbeat, and sweating. If you are experiencing these symptoms, consult your doctor. Your doctor may need to adjust your diabetes medications.
In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Striant (Testosterone)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Striant FDA Prescribing 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%|
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.
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.
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, and venous thromboembolism.
Read the entire FDA prescribing information for Striant (Testosterone) »
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