Testro-LA Side Effects
Generic name: testosterone
Medically reviewed by Drugs.com. Last updated on Mar 17, 2023.
Note: This document contains side effect information about testosterone. Some dosage forms listed on this page may not apply to the brand name Testro-LA.
Applies to testosterone: implant, oil, solution. Other dosage forms:
Warning
Intramuscular route (Solution)
Testosterone undecanoate is available only through a restricted program called the Aveed® REMS Program due to the risk of serious pulmonary oil microembolism (POME) reactions (urge to cough, dyspnea, throat tightening, chest pain, dizziness, syncope) and potentially life-threatening anaphylaxis. These reactions have occurred during or immediately after administration and may occur at any time during the course of therapy, including after the first dose. Monitor patients in a healthcare setting for 30 minutes after each injection.
Subcutaneous route (Solution)
Warning: Blood Pressure IncreasesTestosterone enanthate can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.Before initiating testosterone enanthate, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of testosterone enanthate outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.Due to this risk, use testosterone enanthate only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
Serious side effects of Testro-LA
Along with its needed effects, testosterone (the active ingredient contained in Testro-LA) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking testosterone:
Less common
- Back pain
- bladder pain
- bleeding from the gums or nose
- bloody or cloudy urine
- bluish lips or skin
- changes in mood
- chills
- difficult, burning, or painful urination
- dizziness
- eye pain
- fever
- frequent urge to urinate
- groin pain
- headache
- irritability
- lower back or side pain
- muscle aches
- pain or burning with urination
- ringing in the ears
- stomach pain
- swelling of the arm or leg
Incidence not known
- Arm, back, or jaw pain
- black, tarry stools
- chest pain or discomfort
- confusion
- cough or urge to cough
- decrease in amount of urine
- difficulty with breathing
- difficulty with swallowing
- fainting
- fast, pounding, or irregular heartbeat or pulse
- inability to move the arms, legs, or facial muscles
- nausea
- noisy, rattling breathing
- pain in the chest, groin, or legs, especially the calves
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, or swelling in the arm or leg
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe, sudden headache
- skin rash, hives, itching
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sweating
- swelling of the fingers, hands, feet, or lower legs
- tightening of your throat
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
- vomiting
- weight gain
Other side effects of Testro-LA
Some side effects of testosterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
- Attack, assault, or force
- difficulty in moving
- joint pain
- muscle pain or stiffness
- not able to ejaculate semen
- pain or redness at the injection site
- trouble sleeping
- weight gain
Incidence not known
- Continuing ringing or buzzing or other unexplained noise in the ears
- decreased interest in sexual intercourse
- hair loss or thinning of the hair
- hearing loss
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- loss in sexual ability, desire, drive, or performance
- more erections than usual or erections that last a long time
- swelling of the breasts or breast soreness in both females and males
For Healthcare Professionals
Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, oral capsule, subcutaneous implant, subcutaneous solution, 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 Testro-LA) 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 Testro-LA) 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 Testro-LA) 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 Testro-LA) 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 Testro-LA) 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, azoospermia[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 Testro-LA) 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 Testro-LA)
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 Testro-LA) 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
Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.[Ref]
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]
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 Testro-LA) topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment[Ref]
Renal
Postmarketing reports: Nephrolithiasis, renal colic, renal pain[Ref]
Frequently asked questions
More about Testro-LA (testosterone)
- Check interactions
- Latest FDA alerts (7)
- Dosage information
- During pregnancy
- Drug class: androgens and anabolic steroids
- Breastfeeding
Patient resources
Other brands
AndroGel, Androderm, Xyosted, Depo-Testosterone, ... +14 more
Professional resources
Related treatment guides
References
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.