Testim

Dosage Forms And Strengths

Testim® (testosterone gel) for topical use is available in a unit-dose tube. Each tube contains 50 mg testosterone in 5 g of gel.

Storage And Handling

Testim is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:

Store at 20 to 25°C (68°F to 77°F). Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Discard used Testim tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see BOXED WARNING and WARNINGS AND PRECAUTIONS]. Contents are flammable [see WARNINGS AND PRECAUTIONS].

Manufactured for: Auxilium Pharmaceuticals, Inc. Chesterbrook, PA 19087 USA. By: DPT Laboratories, Ltd. San Antonio, TX 78215. Revised: May 2015

Clinical Studies 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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. Subjects could be counted in both Testim treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both dose levels. Adverse reactions reported by ≥ 1% of the Testim patients and greater than placebo are listed in Table 1.

Table 1: Incidence of Adverse Reactions (Reported by ≥ 1% of the Testim Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days

The following adverse reactions 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 reactions that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, 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 reaction.

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 g/dL) or hematocrit ( ≥ 58%), respectively, compared to 1.0% and 1.5% of patients in the placebo group, respectively.

In the combined US and European open label extension studies, approximately 140 patients received Testim for at least 6 months. The results from these studies are consistent with those reported for the US controlled clinical trial.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of testosterone gel products. Because the 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.

Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or of the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirts and/or other fabric, such as towels and sheets [see WARNINGS AND PRECAUTIONS].

Venous thromboembolism [see WARNINGS AND PRECAUTIONS]

Myocardial infarction, stroke [see WARNINGS AND PRECAUTIONS]

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Testosterone topical (for the skin) is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone topical may also be used for purposes not listed in this medication guide.

Do not apply AndroGel or Testim testosterone gel to your penis or your scrotum. Testim gel should also not be applied to your stomach area.

Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel testosterone gel, or 2 hours after applying Testim testosterone gel.

Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.

If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a testosterone skin patch, avoid using an ointment form of the steroid.

Testosterone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Topical:

Testosterone is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone.

Injectable:

Testosterone is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone. Injectable forms of testosterone may also be used to treat delayed puberty in adolescent males. Testosterone may also be administered to women to treat certain types of cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Testim is part of the drug class:

• 3 oxoandrosten 4 derivatives

Before taking testosterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to testosterone or to any of its ingredients
• have or have had prostate cancer or an enlarged prostate
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

This section provides information on the proper use of a number of products that contain testosterone. It may not be specific to Testim. Please read with care.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Androgel® or Fortesta® is available in two forms: individual packets or multi-dose pump. Vogelxo™ is available in three forms: individual packets, multi-dose pump, or tube. If you are using the pump gel for the first time, prime the pump before measuring out your first dose. Hold the pump over a sink and press the pump all the way down at least 3 times (Androgel® or Vogelxo™) or 8 times (Fortesta®) or until the gel begins to flow freely. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.

If you are using the gel in foil packets, tear the packet completely open along the perforation. Squeeze the entire contents directly onto the skin where you will apply the gel. You may also empty the packet into the palm of your hand and then apply the medicine. Throw away the empty foil packet in a place where children and pets cannot reach it.

Axiron® is available in two forms:

• Pump actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and press the pump all the way down at least 3 times. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.
• Twist actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and twist the dose dial on the bottle. Rinse the medicine discarded into the sink down the drain. Repeat this two more times. Completely twist (180° turn) the dose dial one time after priming to get your correct dose.

AndroGel® is available in two dosage strengths: AndroGel® 1% and AndroGel® 1.62%. AndroGel® 1% is used differently than AndroGel® 1.62%, even though they are both applied to the skin. Do not change your dose unless your doctor tells you to.

To use the gel:

• Make sure that you wash your hands with soap and water before and after applying the gel.
• Apply AndroGel® 1% to a clean, dry, intact skin of the shoulders, upper arms, or abdomen (stomach), unless your doctor tells you to use it on another part of your body. AndroGel® 1.62% should only be applied to a clean, dry intact skin of the shoulders and upper arms. Fortesta® should be applied to a clean, dry, intact skin of the front or inner thighs. Vogelxo™ should be applied to a clean, dry, intact skin of the shoulders or upper arms. Do not apply Vogelxo™ to your abdomen or stomach. Do not apply this medicine to your scrotum or your penis. Do not use the medicine on skin that has a cut, scrape, or other type of injury.
• Allow the gel to dry on your skin before you cover it with clothing (eg, shorts, pants, t-shirt).
• Wait for at least 2 hours (for AndroGel® 1.62%, Fortesta®, and Vogelxo™) or 5 hours (for AndroGel® 1%) after applying this medicine before showering or swimming.

To use the topical solution:

• Apply an antiperspirant or deodorant spray at least 2 minutes before you apply this medicine.
• Apply Axiron® to each clean, dry, intact skin of your underarm using an applicator. Do not apply this medicine to your stomach, penis, scrotum, shoulders, or upper arms. Do not use the medicine on skin that has a cut, scrape, or other type of injury. Do not drink this medicine.
• Wipe any medicine that drips or runs with an applicator. Do not rub the solution with your fingers or hand.
• Pump actuated metered dose bottle: Rinse the applicator cup with water and pat it dry with a tissue. Put the cup and cap back onto the bottle.
• Twist actuated metered dose bottle: Rinse the applicator with water and pat it dry with a tissue. Put the lid back on the bottle.
• Allow the solution to dry for at least 3 minutes before you cover the area with clothing. Do not shower or swim for least 2 hours.
• If any medicine gets in your eyes, rinse them right away with water and call your doctor. Do not drink the medicine.

The gel or solution form can be transferred to another person if they touch or rub the skin where the medicine was placed or if some of it remains on your hands. To keep this from happening, wash your hands again after applying the medicine. Also, wash the area where you applied the gel with soap and water if you expect to have a skin-to-skin contact with another person.

This medicine is flammable until it dries on the skin. Do not use it near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hormone replacement:
  • For topical dosage form (gel):
    • Adults—
      • AndroGel® 1%: At first, apply 50 milligrams (mg) (two 25 mg packets or a single 50 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per day.
      • AndroGel® 1.62%: At first, apply 40.5 milligrams (mg) (2 pumps or a single 40.5 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 81 mg per day.
      • Fortesta®: At first, apply 40 milligrams (mg) (4 pumps) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 70 mg per day.
      • Vogelxo™: At first, apply 50 milligrams (mg) (1 tube, 1 packet, or 4 pumps) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg once a day.
    • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (solution):
    • Adults—At first, apply 60 milligrams (mg) (1 pump or 1 twist actuation of 30 mg) to each clean, dry, intact skin of your underarm once a day (usually in the morning). Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms. Throw away the empty pump, tube, or packet in a place where children and pets cannot reach it.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• There may be a higher chance of prostate cancer. Talk with the doctor.
• If you have an enlarged prostate, your signs can get worse while you use Testim. Call your doctor if this happens to you.
• High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
• Treatment with Testim may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• This medicine is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for treating low testosterone levels caused by getting older. Talk with your doctor.
• This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
• Tell the doctor right away if a child or woman touches the gel or solution and has any bad effects. In children, these are forceful actions, enlarged sex organs, and early growth of pubic hair. In women, these are a deep voice, change in body hair, or pimples.
• If a pregnant woman touches the gel or solution, call the doctor right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Pimples (acne).
• Loose stools (diarrhea).
• Emotional ups and downs.
• Change in sex interest.
• Change in sex ability.
• Feeling tired or weak.
• Not able to sleep.
• Irritation where this medicine is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Testim is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Testim or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Testim. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Testim is supplied in unit-dose tubes in cartons of 30.  Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:

Store at 20° to 25°C (68°F to 77°F). Excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Discard used Testim tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions (5.2)]. Contents are flammable [see Warnings and Precautions (5.16)].

Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, subcutaneous implant, transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution

General

The most frequently reported side effects with this drug are edema, acne, site pain, injection site erythema, cough or dyspnea during or immediately after injection.

The most frequently reported side effects with testosterone (the active ingredient contained in Testim) topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).[Ref]

Dermatologic

Very common (10% or more): Testosterone topical: Skin reaction (16.1%), burn-like blisters (12%), itching, allergic contact dermatitis (up to 37%)
Common (1% to 10%): Acne, induration, burning
Uncommon (0.1% to 1%): Alopecia, erythema, rash (including rash popular), pruritus, dry skin, folliculitis (testosterone (the active ingredient contained in Testim) topical)
Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammation
Postmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis[Ref]

Endocrine

Very common (10% or more): Accelerated growth
Common (1% to 10%): Increased estradiol, hypogonadism
Uncommon (0.1% to 1%): Increased blood testosterone (the active ingredient contained in Testim) Frequency not reported: Signs of virilization in women (e.g., hoarseness, acne, hirsutism, menstrual irregularity, clitoral enlargement, and alopecia), precocious puberty (in prepubertal males)
Postmarketing reports: Hyperparathyroidism, prolactin increased, testosterone increased[Ref]

Gastrointestinal

Very common (10% or more): Testosterone (the active ingredient contained in Testim) buccal film: Gingivitis (32.6%)
Common (1% to 10%): Diarrhea, oily stools (due to IM injection oily solvent); Testosterone topical: Gastroesophageal reflux disease, gastrointestinal bleeding, gum or mouth irritation (9.2%), taste bitter, gum pain, gum tenderness, gum edema, taste perversion
Uncommon (0.1% to 1%): Nausea
Rare (less than 0.1%): Abdominal pain
Frequency not reported: Abdominal disorder, intraabdominal hemorrhage
Postmarketing reports: Vomiting; Testosterone buccal film: Dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis[Ref]

The majority of gum-related adverse events were transient.[Ref]

Local

Very common (10% or more): Testosterone topical: Application site pruritus (up to 37%), application site blistering (12%)
Common (1% to 10%): Injection site pain, injection site discomfort, injection site pruritus, erythema, injection site hematoma, injection site irritation, injection site inflammation; injection site reaction; Topical testosterone (the active ingredient contained in Testim) Application site erythema, application site warmth, application site irritation, application site vesicles, application site exfoliation, application site burning, application site induration, bullae at application site, mechanical irritation at application site, rash at application site, contamination of application site
Postmarketing reports: Injection site abscess, procedural pain, application site swelling (topical testosterone)[Ref]

Cardiovascular

Common (1% to 10%): Hot flush, hypertension
Uncommon (0.1% to 1%): Cardiovascular disorder
Frequency not reported: Venous thromboembolism
Postmarketing reports: Angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia, cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, syncope, thromboembolism, thrombosis, venous insufficiency, stroke[Ref]

Genitourinary

Common (1% to 10%): Abnormal prostate examination, benign prostate hyperplasia (BPH), ejaculation disorder, prostatitis
Uncommon (0.1% to 1%): Prostate induration, prostatic disorder, testicular pain, decreased urine flow, urinary retention, urinary tract disorder, nocturia, dysuria
Rare (less than 0.1%): Micturition disorders, epididymitis, bladder irritability, impotence, inhibition of testicular function and testicular atrophy
Frequency not reported: Oligospermia, priapism, benign prostatic hyperplasia (prostatic growth to eugonadal state), excessive frequency and duration of erections; Pediatrics: Precocious sexual development, an increased frequency of erections, phallic enlargement
Postmarketing reports: Prostate infection, calculus urinary, dysuria, hematuria, urinary tract disorder, pollakiuria[Ref]

Hematologic

Common (1% to 10%): Polycythemia, hematocrit increased
Uncommon (0.1% to 1%): Increased red blood cell count, increased hemoglobin, prolonged activated partial thromboplastin time, prolonged prothrombin time
Frequency not reported: Blood and lymphatic system disorders, suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy
Postmarketing reports: Thrombocytopenia, anemia[Ref]

Metabolic

Common (1% to 10%): Weight increased, appetite increased, fluid retention (sodium, chloride, water, potassium, calcium, and inorganic phosphates)
Uncommon (0.1% to 1%): Increased glycosylated hemoglobin, hypercholesterolemia, increased triglyceride
Frequency not reported: Abnormal lipids (decrease in serum LDL, HDL, and triglycerides), metabolism and nutrition disorders, hypercalcemia
Postmarketing reports: Hypoglycemia, diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia, blood glucose increased[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, hemarthrosis (testosterone (the active ingredient contained in Testim) topical)
Uncommon (0.1% to 1%): Arthralgia, pain in extremity, muscle spasm, muscle strain, myalgia, musculoskeletal stiffness, increased creatine phosphokinase
Frequency not reported: Pediatrics: Premature epiphyseal closure, increased bone formation
Postmarketing reports: Musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus[Ref]

Nervous system

Common (1% to 10%): Headache, vertigo (topical testosterone (the active ingredient contained in Testim)
Uncommon (0.1% to 1%): Migraine, tremor, dizziness
Frequency not reported: Nervousness, paresthesia
Postmarketing reports: Cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack, amnesia[Ref]

Oncologic

Common (1% to 10%): Prostatic specific antigen (PSA) increased, prostate cancer
Uncommon (0.1% to 1%): Prostatic intraepithelial neoplasia
Rare (less than 0.1%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)[Ref]

Other

Common (1% to 10%): Fatigue, hyperhidrosis; chills, body pain, smell disorder
Uncommon (0.1% to 1%): Breast induration, breast pain, sensitive nipples, gynecomastia, increased estradiol, increased testosterone (the active ingredient contained in Testim) asthenia, night sweats
Rare (less than 0.1%): Fever, malaise
Frequency not reported: Edema
Postmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness[Ref]

Psychiatric

Common (1% to 10%): Irritability, insomnia, mood swings, aggression,
Uncommon (0.1% to 1%): Depression, emotional disorder, restlessness, increased libido, decreased libido
Frequency not reported: Hostility, anxiety
Postmarketing reports: Korsakoff's psychosis nonalcoholic, male orgasmic disorder, restlessness, sleep disorder[Ref]

Respiratory

Common (1% to 10%): Sinusitis, nasopharyngitis, upper respiratory tract infection, bronchitis
Uncommon (0.1% to 1%): Cough, dyspnea, snoring, dysphonia
Rare (less than 0.1%): Pulmonary microembolism (POME) (cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope) caused by oily solutions
Frequency not reported: Sleep apnea
Postmarketing reports: Chest pain, asthma, chronic obstructive pulmonary disease, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome[Ref]

Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal LFT, increased AST
Rare (less than 0.1%): Abnormal hepatic function
Frequency not reported: Jaundice, benign liver tumor, malignant liver tumor, liver enlargement, peliosis hepatitis
Postmarketing reports: ALT increased, AST increased, bilirubin increased, transaminases increased, gamma-glutamyltransferase increased[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reactions
Postmarketing reports: Anaphylactic shock[Ref]

Ocular

Uncommon (0.1% to 1%): Testosterone (the active ingredient contained in Testim) topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment[Ref]

Renal

Postmarketing reports: Nephrolithiasis, renal colic, renal pain[Ref]

Some side effects of Testim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.