Safety Information
Safety Information
Last updated: October 20, 2026
MADRES LLC ("MADRES," "we," "us," or "our") is committed to helping patients access care through a convenient telehealth experience. This Safety Information page provides general information about using MADRES and is intended to help you understand important limitations and safety considerations associated with telehealth and prescription treatment.
This page is not medical advice and does not replace your healthcare provider's instructions, your individualized treatment plan, FDA-approved prescribing information, medication guides, pharmacy instructions, or informed consent materials.
If you have questions about whether a treatment is appropriate for you, contact your MADRES provider.
Important Safety Information by Medication
This section summarizes key safety information for medications available through MADRES. It is not complete. Your physician and pharmacy will give you full information about your medication. Tell your physician about every medication, supplement, and health condition you have.
Tirzepatide (including low-dose / microdose plans)
Thyroid tumor warning. In animal studies, tirzepatide caused thyroid C-cell tumors. It is not known whether it causes these tumors, including medullary thyroid carcinoma (MTC), in people. Do not use tirzepatide if you or any family member has ever had MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your physician right away if you notice a lump or swelling in your neck, trouble swallowing, hoarseness, or shortness of breath.
Do not use tirzepatide if you have had a serious allergic reaction to tirzepatide or any of its ingredients, or if you are pregnant or planning to become pregnant.
Birth control. Tirzepatide may make birth control pills taken by mouth work less well. Your physician may recommend a non-oral method, or adding a barrier method, for 4 weeks after you start tirzepatide and for 4 weeks after each dose increase.
Pregnancy. Tirzepatide may harm an unborn baby. If you plan to become pregnant, talk with your physician. Because tirzepatide stays in the body for a long time, it is generally stopped at least 1 month before a planned pregnancy. Tell your physician right away if you become pregnant.
Serious side effects can include: inflammation of the pancreas (severe stomach pain that may spread to your back, with or without vomiting); gallbladder problems; kidney problems, which can be worsened by dehydration from nausea, vomiting, or diarrhea; severe stomach problems; serious allergic reactions; low blood sugar, especially if you also take insulin or a sulfonylurea; changes in vision; and changes in mood or thoughts of self-harm. Tell anyone giving you anesthesia or sedation that you take tirzepatide.
Common side effects include nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, and injection-site reactions. These are most common when starting or increasing a dose.
Do not combine tirzepatide with other tirzepatide products or any other GLP-1 medication.
Hormone Therapy (Estradiol, Progesterone)
Do not use estrogen if you have unexplained vaginal bleeding, have had breast cancer or another estrogen-sensitive cancer, have had blood clots, a stroke, or a heart attack, have liver disease, or are pregnant. If you have a uterus, your physician will usually prescribe progesterone with estrogen, because estrogen alone increases the risk of endometrial (uterine) cancer. In February 2026, the FDA updated the labels of several approved menopausal hormone therapy products, removing cardiovascular disease, breast cancer, and dementia statements from the boxed warning. Hormone therapy still carries risks, and your physician will review your personal and family history with you.
Call your physician right away if you notice new breast lumps, unusual vaginal bleeding, chest pain, leg pain or swelling, sudden severe headache, or changes in vision or speech. Common side effects include breast tenderness, headache, bloating, spotting, and skin irritation where a patch is applied. Progesterone can cause drowsiness or dizziness and is often taken at bedtime. Some progesterone capsules contain peanut oil; tell your physician about any peanut allergy.
Testosterone Cream (for women)
No testosterone product is FDA-approved for women in the United States; prescribing it for women is off-label. Baseline lab work is required before testosterone is prescribed, with periodic follow-up labs. Possible side effects include acne, unwanted facial or body hair, scalp hair thinning, and voice changes, which may be permanent. Testosterone can transfer to others, including children and partners, through skin contact. Wash your hands after applying and keep the area covered until dry. Do not use if you are pregnant, planning pregnancy, or breastfeeding. Testosterone is a controlled substance and is prescribed according to federal and state law.
NAD+ Injections
NAD+ is a self-administered injection. The most common side effect is mild soreness, redness, or bruising at the injection site, which usually resolves on its own. Allergic reactions are rare; seek medical help right away for rash, itching, swelling, or trouble breathing. NAD+ may interact with some medications, so tell your physician about everything you take and any underlying health conditions. Long-term effects of NAD+ injections are not yet fully understood.
Sermorelin
Sermorelin is a self-administered peptide injection that prompts the body to release its own growth hormone. Common side effects include injection-site pain, redness, swelling, or itching, and mild fatigue or dizziness. Less common side effects include headache, flushing, sleepiness, restlessness, and skin itching. Do not use sermorelin if you are pregnant, planning to become pregnant, or breastfeeding, if you have active cancer or cancer not in remission, or if you are allergic to sermorelin. Use caution with thyroid, endocrine, or metabolic conditions. Glucocorticoids (steroids such as prednisone) and thyroid medications may affect how sermorelin works. Your physician may order lab work during treatment. Store refrigerated at 36 to 46°F, do not freeze, and protect from light. Allergic reactions are rare; seek medical help right away for rash, swelling, or trouble breathing.
Compounded Medications
Some MADRES medications are compounded by licensed 503A pharmacies for an individual patient. Compounded medications are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness, or quality. Compounded medications are not the same as, and are not affiliated with, brand-name FDA-approved products.
If you are experiencing a medical emergency, call 911. For questions about your treatment, message your physician through your patient portal. For other questions, contact MADRES at 1-844-456-2373 or support@wethemadres.com.
1. MADRES Is Not an Emergency Medical Service
MADRES's telehealth Services are not intended for medical emergencies or crisis situations.
If you are experiencing a medical emergency, call 911 or go to the nearest emergency department immediately.
Do not rely on MADRES messaging, email, scheduling tools, or customer support for emergency care. These services are not intended to provide continuous or real-time emergency monitoring.
Examples of symptoms that may require immediate in-person medical attention include, but are not limited to:
- Chest pain or pressure
- Severe or sudden difficulty breathing
- Signs of a stroke, including sudden weakness, confusion, difficulty speaking, or facial drooping
- Severe allergic reaction, particularly swelling of the face or throat or difficulty breathing
- Loss of consciousness or severe confusion
- Severe or rapidly worsening pain
- Severe bleeding
- Other symptoms that you believe may be life-threatening
If you are experiencing a mental health emergency or believe you may be at immediate risk of harming yourself or someone else, seek emergency assistance immediately.
When in doubt about whether a situation is an emergency, seek immediate in-person medical care.
2. Telehealth Has Limitations
Telehealth can provide convenient access to healthcare, but it cannot replace every aspect of an in-person medical evaluation.
Depending on your condition, your provider may determine that telehealth is not appropriate or that an in-person examination, laboratory testing, imaging, vital signs, or other evaluation is necessary before treatment can be provided.
Technical problems, incomplete information, or the inability to perform a physical examination may also affect the provider's ability to evaluate or treat a condition.
Your provider may therefore:
- Request additional information or testing;
- Ask you to obtain an in-person examination;
- Recommend that you see your primary care provider or another specialist;
- Decline to prescribe a requested treatment; or
- Recommend another form of care.
The use of MADRES does not guarantee that you will receive a prescription or that any particular treatment will be appropriate for you.
These limitations are inherent to telehealth and are recognized by other major telehealth platforms.
3. Who Provides Your Medical Care
MADRES is a technology and administrative platform. MADRES is not a medical practice, does not itself diagnose medical conditions, and does not make clinical prescribing decisions.
Medical evaluations, diagnoses, treatment recommendations, and prescribing decisions are made by appropriately licensed healthcare professionals participating in the clinical network supporting MADRES.
Your provider is responsible for determining whether telehealth is appropriate for your particular circumstances and whether a medication or treatment is medically appropriate based on your health history, symptoms, medications, laboratory information, and other relevant information.
[BELUGA REVIEW REQUIRED: Confirm the precise legal and operational description of the relationship among MADRES, Beluga Health, the applicable medical group, and individual providers. Replace the above language with the approved contractual description if necessary.]
4. Your Health Information Matters to Your Safety
Your provider's ability to provide safe and appropriate care depends on receiving accurate and complete information.
You should provide truthful, current, and complete information about your:
- Medical history;
- Current and prior medications;
- Allergies and medication reactions;
- Diagnoses and medical conditions;
- Pregnancy or plans to become pregnant, where applicable;
- Supplements and other products you take;
- Recent laboratory or diagnostic results; and
- Symptoms and changes in your health.
You should also tell your provider about any significant changes in your health after receiving treatment.
Do not intentionally withhold health information or provide inaccurate information in order to obtain a prescription. Doing so may result in inappropriate treatment and could cause serious harm.
Accurate patient information is an important component of safe telehealth prescribing.
5. Prescription Medication Safety
Prescription medications can cause side effects, allergic reactions, drug interactions, and other risks.
Before beginning any medication prescribed through MADRES, carefully review the treatment instructions provided by your healthcare provider and the information supplied by the dispensing pharmacy.
Use medications only as directed by your healthcare provider and pharmacy.
Do not:
- Take more medication than prescribed;
- Change your dose without discussing it with your provider;
- Share prescription medication with another person;
- Use medication prescribed to another person;
- Combine medications or supplements without first discussing potential interactions with an appropriate healthcare professional; or
- Continue using a medication if you believe you are experiencing a serious reaction without seeking appropriate medical guidance.
If you have questions about a medication, contact your provider or dispensing pharmacy.
6. Treatment-Specific Safety Information
MADRES may offer access to different categories of prescription treatments depending on clinical protocols, provider availability, pharmacy availability, and applicable federal and state law.
Not every treatment is appropriate for every patient, and the availability of a treatment through MADRES does not mean that the treatment is appropriate for you.
Your provider will determine whether a particular treatment is appropriate based on your individual circumstances.
GLP-1 and Related Metabolic Treatments
Certain metabolic treatments, including medications that act on the GLP-1 pathway, can have significant risks, contraindications, drug interactions, and side effects.
Depending on the medication, important risks may include gastrointestinal side effects, dehydration, gallbladder-related complications, pancreatitis, hypoglycemia when used with certain other medications, and other serious adverse reactions.
Some medications in this category also carry important warnings concerning thyroid C-cell tumors based on animal studies and have specific contraindications. The applicable medication's FDA-approved prescribing information and your provider's instructions control.
[BELUGA/CLINICAL REVIEW REQUIRED: Confirm exact medications offered, including whether tirzepatide and/or other GLP-1/GIP therapies will be offered, and insert medication-specific approved safety language where appropriate.]
Hormone Therapy
Hormonal treatments, including estrogen, progesterone, testosterone, and other hormone therapies, can carry significant risks and are not appropriate for everyone.
Risks and contraindications vary depending on the specific hormone, formulation, route of administration, dose, patient's age, medical history, reproductive status, and other factors.
Potential risks may include blood clots, cardiovascular events, certain cancers, abnormal bleeding, changes in mood or other clinically significant effects.
Your provider will evaluate whether hormone therapy is appropriate for you and will provide treatment-specific instructions and safety information.
Do not begin, stop, or change hormone therapy without discussing the change with your healthcare provider.
[CLINICAL/LEGAL REVIEW REQUIRED: Insert specific safety language only after confirming the actual hormone products, formulations, routes of administration, and prescribing protocols MADRES will offer.]
Compounded Medications
Some treatments available through MADRES may be compounded medications.
Compounded drugs are not FDA-approved. The FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed in the same manner that it reviews FDA-approved drugs.
Compounded medications may be appropriate in certain circumstances, but they may also carry risks specific to the medication, formulation, compounding process, or individual patient.
When a compounded medication is prescribed, your provider and/or dispensing pharmacy will provide applicable instructions and information regarding its use.
[BELUGA/PHARMACY REVIEW REQUIRED: Confirm which MADRES treatments are compounded, the applicable pharmacy's status, and the precise disclosure required for each compounded product.]
Peptides and Other Specialty Treatments
MADRES may offer certain specialty treatments or products, including peptide-based or other therapies, depending on applicable clinical protocols and pharmacy availability.
The safety and effectiveness evidence for some of these treatments may be more limited than for FDA-approved medications, and some may not have FDA approval for the particular use, formulation, or route of administration offered.
Your provider will determine whether a particular treatment is appropriate for you and should explain material risks, benefits, alternatives, and relevant uncertainties before treatment.
[CLINICAL/LEGAL REVIEW REQUIRED: Identify the exact products MADRES intends to offer and provide product-specific language approved by Beluga's clinical/compliance team.]
7. Follow Your Treatment Plan
Your personalized treatment plan is specific to you.
Read all instructions provided by your healthcare provider and dispensing pharmacy before starting treatment. If you do not understand an instruction, contact your provider or pharmacy before using the medication.
Keep your provider informed about changes to your health, medications, symptoms, allergies, and other relevant circumstances.
Do not assume that a medication prescribed for one condition or patient is safe for another person.
8. Side Effects and Adverse Reactions
All medications may cause side effects.
If you experience a new, unexpected, or concerning symptom after starting a treatment, contact your healthcare provider or dispensing pharmacy for guidance.
If you experience symptoms that may indicate a medical emergency, do not wait for a response through MADRES. Call 911 or seek immediate emergency medical care.
Suspected adverse events associated with medications may also be reported to the FDA through MedWatch:
FDA MedWatch
Phone: 1-800-FDA-1088
Online: FDA MedWatch
9. Medication Storage and Handling
Store medications according to the instructions provided by your pharmacy and treatment materials.
Do not use medication that appears damaged, contaminated, improperly stored, or otherwise inconsistent with the instructions you received.
Keep prescription medications out of reach of children and others for whom they were not prescribed.
Follow pharmacy instructions for disposal of unused or expired medication.
10. Pregnancy, Breastfeeding, and Other Special Circumstances
Certain medications may not be appropriate during pregnancy or breastfeeding, and some treatments require additional precautions depending on your reproductive status.
Tell your provider if you are:
- Pregnant or think you may be pregnant;
- Trying to become pregnant;
- Breastfeeding;
- Planning a procedure or surgery; or
- Experiencing a significant change in your health.
Your provider will determine whether treatment should be started, continued, changed, or discontinued based on your individual circumstances.
11. Your Existing Healthcare Team
MADRES is intended to complement, rather than necessarily replace, your existing healthcare relationships.
Unless otherwise directed by your provider, you should continue seeing your primary care provider and other healthcare professionals involved in your care.
You should tell your healthcare providers about medications and treatments you receive through MADRES so that they can consider your complete treatment history.
12. Treatment Outcomes Are Not Guaranteed
Individual responses to prescription treatments vary.
MADRES and its providers do not guarantee that a particular medication or treatment will produce a particular result, improve a particular symptom, cause weight loss, change hormone levels, regrow hair, improve skin, or produce any other specific outcome.
Your provider will determine whether a treatment is appropriate and may modify or discontinue treatment based on your response, safety considerations, or changing medical circumstances.
13. Advertising, Testimonials, and Individual Results
From time to time, MADRES may use testimonials, reviews, photographs, or other patient experiences in connection with its marketing.
Individual experiences and treatment outcomes vary. Testimonials are not a guarantee or representation that another patient will experience the same result.
[LEGAL/COMPLIANCE REVIEW REQUIRED BEFORE MARKETING LAUNCH: Confirm final testimonial, before-and-after, influencer, paid-endorsement, dramatization, and health-claim disclosures against applicable FTC, FDA, state advertising, and professional-practice requirements.]
14. Questions About Your Treatment
For questions about your specific medical condition, prescription, dosage, side effects, or treatment plan, contact your MADRES healthcare provider through the patient platform or contact the dispensing pharmacy as appropriate.
For technical, account, billing, or general customer-support questions, contact MADRES at:
MADRES LLC
12555 Biscayne Blvd #1006
North Miami, FL 33181
[Support Email]
786-505-4790
MADRES customer support is not a substitute for medical care and should not be used for emergencies.