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Andro LA 200 Side Effects

Generic name: testosterone

Medically reviewed by Drugs.com. Last updated on Oct 14, 2023.

Note: This document contains side effect information about testosterone. Some dosage forms listed on this page may not apply to the brand name Andro LA 200.

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, 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 Andro LA 200) 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 Andro LA 200) 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 Andro LA 200) 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 Andro LA 200) 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 Andro LA 200) 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 Andro LA 200) 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 Andro LA 200)

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 Andro LA 200) 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 Andro LA 200) 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

References

1. Product Information. Androderm (testosterone topical). SmithKline Beecham. 2001;PROD.

2. Product Information. Testopel (testosterone). Bartor Pharmacal Co, Inc. 2002.

3. Cerner Multum, Inc. UK Summary of Product Characteristics.

4. Cerner Multum, Inc. Australian Product Information.

5. Product Information. Depo-Testosterone (testosterone). Pfizer U.S. Pharmaceuticals Group. 2014.

6. Product Information. Testosterone Enanthate (testosterone). West Ward Pharmaceutical Corporation. 2014.

7. Product Information. Aveed (testosterone). Endo Pharmaceuticals Solutions Inc. 2014.

8. Product Information. Testim (testosterone). A-S Medication Solutions. 2015.

9. Product Information. Fortesta (testosterone). Endo Pharmaceuticals (formally Indevus Pharmaceuticals Inc). 2015.

10. Product Information. Axiron (testosterone). Lilly, Eli and Company. 2015.

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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.