Drug Safety And Information
Drug Safety and Information
Treatment Side Effects: Full Disclosure and Notice
Medications may have potential side effects. This section provides you with information about the known side effects of the medications used in the compounding formulas offered by MANE & STEEL. This is not a complete list, and additional side effects may be found in the literature not covered in this section.
Disclaimer of Liability: By using MANE & STEEL, you agree that in no event shall MANE & STEEL, its officers, directors, employees, health counselors, independent contractors, staff physicians, or agents, be liable for any direct (including death), psychological, emotional, indirect, incidental, financial, special, punitive, or consequential damages resulting from:
- The purchase and use of products sold on our website.
- Any side effects that these medications may have, whether alone or compounded together in a formula.
If you are concerned about the side effects of these medications, please do not use MANE & STEEL. By agreeing to purchase and use MANE & STEEL products, you acknowledge and accept the side effects stated below and understand that any of these side effects may occur and be either temporary or permanent. You also agree that there may be side effects not listed here, and this is not a complete list of side effects.
Responsibility: We do not take any responsibility for the safety or efficacy of any products sold through this website, nor for any possible side effects that may result from the use of these products. By viewing this Drug Safety & Information page, you confirm that you have provided accurate medical history and correctly informed your prescribing physician of all ongoing medical conditions, risk factors, medications, and/or allergies, and that you have been examined by a physician to confirm your health status prior to your telemedicine visit. It is highly encouraged for consumers to consult their personal physicians about the safety and efficacy of such products before use.
None of the products sold on this website are intended to treat, prevent, cure, relieve, resolve, or stop any type of medical condition. Compound prescription products have not been tested or approved by the FDA for their intended use.
The information provided by our healthcare counselors does not replace consulting with your primary care physician regarding your medical conditions and your treatment with oral or topical compounded formulations containing Dutasteride, Minoxidil. Please read all this information before you start taking any of our prescribed formulations and review this information every time you get a new refill, as the information may change and there may be updated, new information provided.
Dutasteride Side Effects: Full Disclosure and Notice to Users
Read this section before you start taking Dutasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Dutasteride has been FDA approved for use in men for benign prostatic hyperplasia in the oral form, all other formulations are off-label. For full transparency, side effects of Dutasteride include but not limited to hypersensitivity reaction (allergic reaction), angioedema, prostate cancer (high-grade), breast cancer, male infertility, Impotence, loss in sexual ability, desire, drive, or performance, decrease libido, hypotension, abnormal ejaculation, depression, anxiety, sexual dysfunction, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, penile fibrosis, penile scarring, decrease volume of ejaculate, tenderness in genital organs, testicular pain, infertility, poor seminal quality, poor sperm mobility, gynecomastia (enlarge breast tissue), swelling in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, hair loss (temporary or permanent), change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, runny nose, sleepiness or unusual drowsiness, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, breast cancer in males and females, depression, lower testosterone, and shrinkage of sexual organs. All sexual side effects may be long-term (permanent). Impotence, loss in sexual ability, desire, drive, or performance, decrease libido, hypotension, abnormal ejaculation, sexual dysfunction, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, decrease volume of ejaculate, tenderness in genital organs, testicular pain, infertility, poor seminal quality, testicular pain, testicular numbness, poor sperm mobility, gynecomastia (enlarge breast tissue), swelling in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, brain fog, fogginess of the head, short-term and long-term memory loss, terrible fatigue, trouble concentrating, increasingly moody, depression, runny nose, sleepiness or unusual drowsiness, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, , depression, lower testosterone, complete loss of testosterone, breast cancer, heart failure, atrial fibrillation, teratogenesis, visual impairment, exfoliative dermatitis, Stevens-Johnson syndrome, angioedema, erythema multiforme, ejaculation dysfunction, impotence (erectile dysfunction), orthostatic hypotension, priapism, testicular swelling, hypotension, palpitations, dyspnea, chest pain (unspecified), blurred vision, floppy iris syndrome, edema, constipation, depression, libido decrease, dizziness, vertigo, syncope, diarrhea, sinusitis, cough, rhinitis, back pain, asthenia, pharyngitis, insomnia, infection, drowsiness, testicular pain, orgasm dysfunction, decreased ejaculate volume, breast enlargement, gynecomastia, rash, urticaria, pruritus, vomiting, xerostomia, epistaxis, oligospermia, spermatogenesis inhibition. Although Dutasteride is not the same as Finasteride, possibility of post-dutasteride syndrome may still exist and will cite the post-finasteride syndrome as a reference as a possibility of side effects. Post-finasteride syndrome: www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/, and shrinkage of sexual organs. All sexual side effects may be long-term (permanent).
Patients must not share the medication with any female. Dutasteride is not FDA approved for use in women but may be used off-label to treat hair loss in women under some circumstances. Dutasteride is a Category X (teratogenic) medication due to the potential to cause birth defects in male fetuses. Pregnant women and children should not use or come into direct skin contact with Dutasteride. The effectiveness of Dutasteride for hair loss in women as well as the potential risks/side effects are not well understood because large scale clinical trials have not been done in this population. When used off-label to treat hair loss in women, small studies have indicated that women experience similar side effects to men taking Dutasteride (as listed above). Women may additionally experience dry skin, acne, headaches, irregular menses, increased body hair, headache, dizziness, fatigue, weight gain, elevated liver enzyme, and edema. There have been reports of breast cancer in men who have taken oral Finasteride and it is unknown how this risk may translate to women taking Dutasteride.
There may also be other side effects that may occur that have not been listed. This is intended to give full transparency about the possibility of the side effects of Dutasteride, some of which may be long term, and that you are fully informed about the above side effects. Our goal is to empower our patients to make educated decisions about their treatment choices. The above is not a complete list of all side effects or studies conducted. With respect to labs, you are responsible for checking your PSA levels with your own primary care physician.
Do not use Dutasteride if you have orthostatic hypotension, vertigo, or syncope. Dutasteride is not intended for use in neonates, infants, children, and adolescents under 18 years of age. Safety and effectiveness have not been established in this age group. Patients receiving or who have previously received treatment with Dutasteride or other alpha-1 blockers may be at risk for intraoperative floppy iris syndrome during surgery for cataracts (ocular surgery). Dutasteride is a non-arylamine sulfonamide derivative. In patients with sulfonamide hypersensitivity, allergic reaction to tamsulosin has been rarely reported. If a patient reports a serious or life threatening sulfonamide allergy, the manufacturer advises caution when administering Dutasteride. Rarely (probably less than 1 in 50,000) like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Dutasteride should be used with caution in patients with hepatic disease. Pregnant women or women trying to conceive or women who are breastfeeding should not handle Dutasteride. Dutasteride is not indicated for use in females, and the use of this product during pregnancy is contraindicated. Infertility, decreased semen production or any fertility issue may be associated with use of Dutasteride.
Dutasteride & PSA (Prostate Specific Antigen): PSA test is a screening blood test performed by your physician to check for prostate cancer. Dutasteride has been shown to reduce the PSA level, sometimes as much as 50%. The significance of this is as follows. Reduction in PSA can mask underlying prostate cancer. When you have a PSA test done, it is imperative that you tell your physician that you are taking Dutasteride in order to better assess the real PSA value of your blood test. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels are within normal limits. You should always tell your physician if you are or are not taking Dutasteride, as this will impact the actual interpretation of your PSA level.
The American Academy of Family Physicians and the Canadian Task Force on Preventive Health Care recommend against PSA-based screening for prostate cancer. The American College of Physicians recommends that clinicians discuss the benefits and harms of screening with men aged 50 to 69 years and only recommends screening for men who prioritize screening and have a life expectancy of more than 10 to 15 years. The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years be informed of the benefits and harms of screening and engage in shared decision making with their clinicians, taking into account each man’s values and preferences. It notes that to reduce the harms of screening, the screening interval should be 2 or more years. The American Urological Association also notes that decisions about screening, including potentially starting screening before age 55 years, should be individual ones for African American men and men with a family history of prostate cancer. The American Cancer Society adopted detailed screening recommendations in 2016 that highlight the importance of shared decision making and the need for informed discussion of the uncertainties, risks, and potential benefits of screening. It recommends conversations about screening beginning at age 50 years and earlier for African American men and men with a father or brother with a history of prostate cancer before age 65 years.
Again, Dutasteride can have rare and uncommon side effects that you should be aware of. This includes sexual side effects (such as decreased libido, erectile dysfunction), psychological side effects (such as depression or anxiety) and similar side effects to the post-finasteride syndrome. If these side effects do occur, even if mild, please report them to your doctor immediately and stop taking the medication. There is an increased risk of the more advanced stage of (high grade) prostate cancer or serious prostate cancer. In rare cases, male breast cancer has also been reported. Oral Dutasteride is an FDA approved medication used to treat enlarged prostate and has been used off-label for treating male pattern hair loss. Compounded medications are not approved by the FDA. Topical version of the Dutasteride has not been tested/approved by the FDA. The combination of Dutasteride, Minoxidil, Retinoic Acid and/or Hydrocortisone is a compounded prescription medication prescribed by your doctor and not tested/approved by the FDA.
PREGNANCY WARNING: Females who are pregnant or who may become pregnant should not come in contact with Dutasteride. Dutasteride may harm your unborn baby. If a woman who is pregnant or a child comes in contact with Dutasteride solution or crushed pills, please wash the area right away with soap and water and contact your healthcare provider. If a pregnant woman with a male baby fetus swallows or comes in contact with Dutasteride, the male baby may be born with sex organs that are not normal. Dutasteride may also affect sperm counts/quality and can be secreted in the sperm in very low amounts, but currently there are no recommendations based on data from clinical trials to suggest that men should avoid taking Dutasteride during conception or while a partner is pregnant.
Minoxidil Side Effects: Full Disclosure and Notice to Users
Before you start using Minoxidil and each time you get a refill, please review this section. This information does not replace discussing your medical condition or treatment with your healthcare provider.
Topical Minoxidil is FDA approved as a treatment for hair loss in men and women as a 2% and 5% topical formulation. All other topical compounded strengths of Minoxidil are considered off-label for hair loss treatment. Oral Minoxidil is FDA approved for symptomatic high blood pressure that is not controlled by a diuretic plus two other blood pressure lowering drugs. Your provider may recommend a low dose of oral Minoxidil as an off-label treatment for hair loss.
Contraindications: You should not use Minoxidil if you are allergic to it, or if you have a pheochromocytoma (tumor of the adrenal gland).
Black Box Warning for Serious Cardiac Effects
- Oral Minoxidil has a black box warning because the medication is a powerful antihypertensive agent and can produce serious adverse effects. Note that serious cardiovascular side effects from oral Minoxidil have been demonstrated in clinical trials evaluating patients with symptomatic high blood pressure that was not controlled by a diuretic plus two other blood pressure lowering drugs and using oral Minoxidil at doses of 5mg or higher. When used off-label for hair loss, oral Minoxidil is dosed at less than 5mg in an attempt to avoid blood pressure lowering effects and reduce adverse cardiovascular effects.
- Minoxidil can cause pericardial effusion, the accumulation of too much fluid in the sac that surrounds the heart (pericardium). Pericardial effusion can progress to a condition called tamponade which increases pressure on the heart and keeps it from beating properly. This can result in sharp chest pain and difficulty breathing. Seek emergency treatment if this occurs.
- When using Minoxidil to treat high blood pressure, it should be reserved for patients who do not respond adequately to maximum therapeutic doses of a diuretic (water pill) and two other blood pressure lowering drugs. It must be administered under close supervision, usually along with a beta-blocking agent to prevent increased heart rate (tachycardia) and increased the stress put on the heart muscle (myocardial workload). It must also usually be given with a diuretic to prevent serious fluid accumulation.
- Chest pain warning: Minoxidil can increase your heart rate and cause or worsen chest pain (angina). Doctors usually prescribe a beta-adrenergic blocking drug with Minoxidil to avoid this. If you have new or worsening pain in the chest, arm, or shoulders, tell your doctor right away.
- Heart function warning: Minoxidil can cause poor heart function or worsen existing heart problems like heart failure. When tested on animals, Minoxidil caused several kinds of lesions of the heart muscle as well as other adverse heart effects. Patients with malignant hypertension and those already receiving guanethidine should be hospitalized when Minoxidil is first administered so that they can be monitored to avoid too rapid or large decreases in blood pressure.
Comorbidities/Precautions:
- Minoxidil should be used with caution in patients with heart conditions or cardiovascular disease or at high risk for these (including conditions like stroke, heart attack, or congestive heart failure) and liver or kidney disease. It is recommended that you obtain clearance from your cardiologist and primary care doctor prior to beginning oral Minoxidil for hair loss therapy. Ensure you disclose your entire medical history to your healthcare provider. Be aware that withholding or providing inaccurate health and medical history to obtain treatment can have serious consequences, potentially including death.
- Do not use topical Minoxidil if you have active skin abrasion or irritations, such as excoriations, open wounds, psoriasis, or sunburn. This can increase your risk for skin irritation and systemic absorption of topically administered Minoxidil. The topical formulation is meant for external use only and should not be ingested or applied to other body parts.
Pregnancy and Special Populations: Minoxidil is pregnancy category C, indicating that its safety in pregnant women has not been fully established. Animal studies have shown risk to the fetus, but there are no controlled studies in women. It should be avoided by women who are pregnant, planning pregnancy, or breastfeeding.
Drug-interactions: Minoxidil may interact with other medications, especially those that affect blood pressure or heart function. Guanethidine should not be taken with Minoxidil. Always inform your healthcare provider of all the medications you are currently taking. You may need to limit or reduce the salt in your diet while taking Minoxidil. Do not use potassium supplements or salt substitutes, unless your doctor has told you to. Do not take Minoxidil with sildenafil or tadalafil.
Common side effects for topical and oral Minoxidil:
- Initial shedding or increased hair loss in the first weeks of use.
- Itchy scalp or skin rash.
- Dryness, scaling, or flakiness of the scalp.
- Redness or irritation at the application site.
- Unwanted facial or body hair growth, especially in women.
- Dizziness or lightheadedness.
- Rapid or irregular heartbeat.
- Chest pain or palpitations.
- Swelling of hands, feet, or face.
- Difficulty breathing when lying down.
- Weight gain due to fluid retention.
The most serious side effects of oral Minoxidil are reviewed below. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes:
Salt and water retention: Monitor for fluid retention and increase in body weight. If you quickly gain five or more pounds, or if there is any swelling or puffiness in the face, hands, ankles, or stomach area, this could be a sign that you are retaining body fluids. Contact your provider immediately.
Increased heart rate (tachycardia): Oral Minoxidil can increase your heart rate. Chest pain/angina may worsen or appear for the first time during oral Minoxidil therapy, likely due to the increased oxygen demands associated with increased heart rate and cardiac output. You should measure your heart rate by counting your pulse rate while you are resting. If you have an increase of 20 beats or more a minute over your normal pulse or experience new/worsening chest pain, contact your provider immediately or seek urgent care.
Pericarditis, Pericardial Effusion and Tamponade: Oral Minoxidil can cause an accumulation of fluids in the sac surrounding the heart. Monitor for sharp pain in the chest, arm, or shoulder; signs of severe indigestion; or shortness of breath, dizziness, lightheadedness, and fainting. These could be signs of serious heart problems and you should seek immediate emergency care.
Hazard of Rapid Control of Blood Pressure: A sudden or too large of a drop in blood pressure can lead to fainting, heart attack, and loss of blood flow to certain organs. These are signs of serious heart problems and you should seek immediate emergency care. You should monitor your blood pressure closely when starting oral Minoxidil or changing dosing.
If you experience severe symptoms or are having a medical emergency, call 911 or seek immediate medical attention.
The above does not encompass all potential side effects, medication interactions, or studies related to Minoxidil. Unreported or yet undiscovered side effects might exist. Please review the FDA prescribing information and the Prescriber’s Digital Reference (PDR) for a comprehensive overview of Minoxidil:
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018154s026lbl.pdf
- https://medlineplus.gov/druginfo/meds/a682608.html
When considering Minoxidil therapy for hair loss in the topical or oral form, it’s essential to weigh the potential benefits against the potential risks. Always discuss any concerns, symptoms, or side effects with your healthcare provider. Lastly, every individual may respond differently to medications. It’s essential to stay informed and regularly consult with healthcare professionals to ensure the therapy remains suitable for you.
Sermorelin + Glycine Peptide Therapy
NAD+ Side Effects: Full Disclosure and Notice to Users
NAD+ (Nicotinamide Adenine Dinucleotide) is generally safe. However, like all supplements, it may come with some side effects.
Common Side Effects:
- Nausea
- Fatigue
- Headache
Less Common Side Effects:
- Dizziness
- Indigestion
- Mild skin rash
- Abdominal discomfort
Rare Side Effects:
- Flushing
- Increased heart rate
- Shortness of breath
- Severe allergic reactions (rash, itching, swelling, difficulty breathing)
Incidence Not Known:
- Anxiety
- Insomnia
- Mood swings
- Joint pain
- Muscle cramps
- Changes in appetite
- Increased sweating
- Tingling or numbness
These side effects may go away during treatment as your body adjusts to the supplement. Always consult your healthcare provider if you experience any side effects or have concerns about your treatment with NAD+.
Common Side Effects:
- Diarrhea (more common)
- Constipation (less common)
Less Common Side Effects:
- Hair loss
Rare Side Effects:
- Rash
- Scarring
- Pain
- Redness
- Blistering
- Tingling
- Burning sensation
- Soreness
- Ulceration
- Numbness
- Swelling
- Tenderness
- Infection
- Lumps
- Itching
- Inflammation
- Coldness
- Feeling of pressure
- Discoloration of the skin
- Hives
- Stinging
- Bleeding
- Warmth at the injection site
- Change in taste
- Loss of taste
Less Common Side Effects:
- Belching
- Passing gas
- Yellow eyes or skin
- Recurrent fever
- Heartburn
- Bloated, full feeling
- Stomach discomfort, fullness, or pain
- Gaseous stomach pain
- Excess air or gas in the stomach or intestines
Rare Side Effects:
- Indigestion
- Burning feeling in the chest or stomach
- Tenderness in the stomach area
- Stomach upset
Incidence Not Known:
- Trouble breathing
- Cool, pale skin
- Tiredness
- Blurred vision
- Loss of consciousness
- Nausea
- Seizures
- Cough
- Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- Increased hunger
- Anxiety
- Discouragement
- Skin rash
- Darkened urine
- Fast heartbeat
- Shakiness
- Vomiting
- Hives, itching
- Lack of appetite
- Dizziness
- Slurred speech
- Chest tightness
- Increased heart rate
- Confusion
- Nightmares
- Redness of the skin
- Cold sweats
- Trouble sleeping
- Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- Feeling sad or empty
- Pains in stomach, side, or abdomen, possibly radiating to the back
- Trouble concentrating
- Irritability
- Unusual tiredness or weakness
- Headache
- Loss of interest or pleasure
These side effects may go away during treatment as your body adjusts to the medication. Always consult your healthcare provider if you experience any side effects or have concerns about your treatment with Semaglutide.
Tadalafil
Tadalafil: Full Disclosure and Notice to Users
Tadalafil is generally safe. However, like all medications, it may come with some side effects.
Common Side Effects:
- Headache
- Indigestion
- Back pain
- Muscle aches
- Flushing
Less Common Side Effects:
- Nasal congestion
- Dizziness
- Abdominal discomfort
- Nausea
Rare Side Effects:
- Chest pain
- Severe allergic reactions (rash, itching, swelling, difficulty breathing)
- Heart palpitations
- Shortness of breath
- Priapism (prolonged erection)
Incidence Not Known:
- Anxiety
- Insomnia
- Mood swings
- Joint pain
- Muscle cramps
- Changes in appetite
- Increased sweating
- Tingling or numbness
- Vision changes
- Hearing loss
- Low blood pressure
These side effects may go away during treatment as your body adjusts to the medication. Always consult your healthcare provider if you experience any side effects or have concerns about your treatment with Tadalafil.
