Important Safety Information for Testosterone Therapy

Important Medical Disclaimer

Completing the online assessment via the Alorah Wellness platform does not establish a formal doctor-patient relationship. All clinical evaluations and healthcare services are facilitated by OpenLoop Health and a network of licensed U.S. medical professionals.

These clinicians hold sole authority to determine a patient’s suitability for hormone therapy based on their comprehensive medical profile and assessment data. Providers maintain absolute clinical discretion regarding the prescription or denial of any testosterone therapies.

Medication Safety & Standards

  • Regulatory Status: Testosterone products prescribed through Alorah Wellness may include compounded medications prepared in FDA-registered facilities. Compounded medications are not FDA-approved and have not been independently evaluated by the FDA for safety, quality, or therapeutic effectiveness.
  • Manufacturing: Alorah Wellness does not manufacture pharmaceuticals. We partner exclusively with certified U.S. compound pharmacies dedicated to rigorous quality control and safety protocols. Please note that the physical appearance, packaging, or labeling of the medication you receive may differ from the images or representations shown on our website.
  • Costs: Alorah Wellness membership programs include the cost of medication unless otherwise specified.

Expectations & Results

Therapeutic outcomes are highly individual and rely on consistent adherence to the treatment plan, clinical guidance, and lifestyle considerations. Any patient testimonials or success stories shared by Alorah Wellness reflect the personal experiences of our members rather than data from controlled clinical trials. A licensed provider will evaluate your symptoms, health history, and available clinical information to determine whether treatment is appropriate and may adjust care as clinically necessary.

Medication Overview

Testosterone therapy is a prescription treatment that may be used in provider-guided hormone programs when clinically appropriate. Testosterone plays a role in multiple physiologic functions and may be evaluated as part of a broader hormone management program for individuals experiencing symptoms associated with hormone imbalance.

Treatment decisions are made solely by licensed medical professionals who review your symptoms, health history, and available laboratory data to determine whether testosterone therapy may be appropriate for you.

Prescription Drug Disclosure

Testosterone products prescribed through Alorah Wellness may include compounded medications. Compounded drugs may be prescribed under applicable federal law but are not FDA-approved and do not undergo FDA review for safety, effectiveness, or manufacturing quality.

Limitations of Use

  • Testosterone therapy is not intended for bodybuilding or athletic performance enhancement.
  • This therapy may not be appropriate for all individuals experiencing symptoms related to hormone changes.
  • Eligibility and treatment decisions are determined by a licensed healthcare provider following clinical evaluation.

Who Should Not Use Testosterone Therapy?

Do not use testosterone therapy if:

  • You have a known allergic reaction to testosterone or any component of the prescribed formulation.
  • You have certain hormone-sensitive cancers unless your healthcare provider determines treatment may be appropriate.
  • You are pregnant or may become pregnant, as testosterone exposure may cause harm to a developing fetus.

What Should I Tell My Provider Before Using Testosterone Therapy?

Before beginning treatment, your provider should review your complete medical history and current medications. Tell your provider about all prescription medications, over-the-counter medications, vitamins, herbal products, and other treatments you are currently using.

Some medications to discuss with your provider include:

  • Anticoagulants or blood thinners
  • Insulin or other diabetes medications
  • Corticosteroids
  • Other hormone therapies or anabolic agents

Tell your provider if you have or have had a history of:

  • Heart disease or cardiovascular conditions
  • High blood pressure
  • Blood clots or clotting disorders
  • Sleep apnea
  • Kidney or liver disease
  • Hormone-sensitive cancers

Pregnancy and Breastfeeding

Testosterone therapy is not intended for use during pregnancy. Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding so they can determine whether treatment is appropriate.

Important: Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm.

What Are the Most Serious Side Effects to Monitor For?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

Serious side effects may occur. Contact your healthcare provider or seek medical attention if you experience:

  • Blood Clots: Chest pain, shortness of breath, coughing up blood, or leg swelling and pain.
  • Heart Attack or Stroke: Sudden chest pressure, weakness or numbness, difficulty speaking, severe headache, or sudden vision changes.
  • High Red Blood Cell Count: Your provider may monitor laboratory tests to evaluate for elevated red blood cell levels.
  • Severe Allergic Reactions: Swelling of the face, lips, tongue, or throat; severe rash; trouble breathing; or fainting.
  • Severe Mood or Behavioral Changes: Contact your provider if you experience significant irritability, aggression, depression, or other concerning mood changes.

What Are the Most Common Side Effects?

Possible side effects may include:

  • Acne or oily skin
  • Injection site irritation
  • Fluid retention or swelling
  • Changes in red blood cell levels
  • Mood changes or irritability
  • Hair thinning
  • Breast tenderness

Reporting Side Effects

You are encouraged to report negative side effects of dietary supplements or other medical products:

  • FDA MedWatch: 1-800-FDA-1088
  • Visit: www.fda.gov/medwatch
  • Contact your provider immediately with any adverse reactions or side effects

This information is not comprehensive. Please consult your healthcare provider for complete safety information and guidance specific to your health history.

The Food and Drug Administration has not evaluated these statements. The FDA neither approves nor reviews compounded products for safety, effectiveness, or quality. This product is not intended to diagnose, treat, cure, or prevent any disease.

All medications listed are prescription-only products and require a consultation with a licensed healthcare provider. Always consult with a professional before starting a new treatment.