Testim Side Effects
Generic Name: Testosterone
Please note - some side effects for Testim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
|
For the consumer For the professional
|
|
Side Effects of Testim - for the consumer
Testim Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Testim Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Testim Gel:Acne; bitter or strange taste in mouth; change in sex drive; dry skin; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache; skin irritation at the application site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; dark urine or light-colored bowel movements; decreased urination; depression or mood changes; dizziness; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; stomach pain; swelling of the ankles or legs; unusual tiredness or weakness; urination problems; weight gain; yellowing of the skin or eyes.
For the professional
Testim
In a controlled clinical study, 304 patients were treated with Testim® 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received Testim® 50 mg or 100 mg daily and 99 patients received placebo. Patients with adverse events that were possibly or probably related to study drug and reported by ≥1% of the Testim® patients and greater than placebo are listed in Table 3.
| Event | Testim®50 mg | Testim®100 mg | Placebo |
|---|---|---|---|
| Application Site Reactions | 2% | 4% | 3% |
| Benign Prostatic Hyperplasia | 0% | 1% | 1% |
| Blood Pressure Diastolic Decreased | 1% | 0% | 0% |
| Blood Pressure Increased | 1% | 1% | 0% |
| Gynecomastia | 1% | 0% | 0% |
| Headache | 1% | 1% | 0% |
| Hematocrit/hemoglobin Increased | 1% | 2% | 0% |
| Hot Flushes | 1% | 0% | 0% |
| Insomnia | 1% | 0% | 0% |
| Lacrimation Increased | 1% | 0% | 0% |
| Mood Swings | 1% | 0% | 0% |
| Smell Disorder | 1% | 0% | 0% |
| Spontaneous Penile Erection | 1% | 0% | 0% |
| Taste Disorder | 1% | 1% | 0% |
The following adverse events possibly or probably related to Testim® occurred in fewer than 1% of patients but were greater in Testim® groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne.
In this clinical trial of Testim®, six patients had adverse events that led to their discontinuation. These events included: vertigo, coronary artery disease, depression with suicidal ideation, urinary tract infection/pneumonia (none of which were considered related to Testim® administration), mood swings and hypertension. No Testim® patients discontinued due to skin reaction.
In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse event. In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin (≥ 19 gm/dL) or hematocrit (≥ 58%), respectively.
In the combined ongoing U.S. and European open label extension studies, approximately 140 patients received Testim® for at least 6 months. The preliminary results from these studies are consistent with those reported for the U.S. controlled clinical trial.
TopMore resources:
Androderm - Includes detailed dosage instructions.
Striant - Includes detailed dosage instructions.
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
