Medications may have potential side effects. This section provides full disclosure about the known side effects of the medications used in compounding formulas offered by MANE & STEEL. This is not a complete list, and additional side effects may exist that are not covered here.
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, or 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.
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 or 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.
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.
All sexual side effects may be long-term (permanent). This includes impotence, loss of sexual ability, desire, drive, or performance, decreased libido, erectile dysfunction, decreased ejaculate volume, testicular pain, testicular numbness, infertility, poor seminal quality, and poor sperm mobility, among others. If any of these side effects occur, even if mild, please report them to your doctor immediately and stop taking the medication.
Orthostatic hypotension, vertigo, or syncope. Dutasteride is not intended for use in individuals 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 cataract surgery. Inform your surgeon.
Rarely, Dutasteride has been associated with priapism (persistent painful erection unrelated to sexual activity). An erection lasting more than 4 hours requires emergency medical attention to avoid permanent damage.
Dutasteride should be used with caution in patients with hepatic disease. Infertility, decreased semen production, or any fertility issue may be associated with use of Dutasteride.
Dutasteride is a non-arylamine sulfonamide derivative. In patients with sulfonamide hypersensitivity, allergic reaction has been rarely reported. If you report a serious or life-threatening sulfonamide allergy, the manufacturer advises caution when administering Dutasteride.
Patients must not share this 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.
When used off-label to treat hair loss in women, small studies have indicated that women experience similar side effects to men. Women may additionally experience dry skin, acne, headaches, irregular menses, increased body hair, dizziness, fatigue, weight gain, elevated liver enzymes, 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.
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, wash the area immediately with soap and water and contact your healthcare provider. If a pregnant woman carrying a male fetus swallows or comes in contact with Dutasteride, the male baby may be born with sex organs that are not normal.
Dutasteride may affect sperm counts and quality and can be secreted in sperm in very low amounts. Currently there are no recommendations based on clinical trial data to suggest that men should avoid taking Dutasteride during conception or while a partner is pregnant.
PSA (Prostate Specific Antigen) is a screening blood test performed by your physician to check for prostate cancer. Dutasteride has been shown to reduce the PSA level, sometimes by as much as 50%. This reduction can mask underlying prostate cancer.
When you have a PSA test done, you must tell your physician that you are taking Dutasteride in order to better assess the real PSA value. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels appear within normal limits. Always inform your physician whether or not you are taking Dutasteride, as this will impact interpretation of your PSA level.
Various medical organizations have differing screening recommendations. The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years engage in shared decision making with their clinicians. African American men and men with a family history of prostate cancer may benefit from earlier screening discussions. The American Cancer Society recommends conversations about screening beginning at age 50, and earlier for higher-risk individuals.
With respect to labs, you are responsible for checking your PSA levels with your own primary care physician.
There is an increased risk of high-grade prostate cancer. In rare cases, male breast cancer has also been reported. Oral Dutasteride is FDA approved for enlarged prostate and has been used off-label for male pattern hair loss. Compounded medications are not approved by the FDA. The topical version of Dutasteride has not been tested or approved by the FDA.
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 are considered off-label. Oral Minoxidil is FDA approved for symptomatic high blood pressure 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.
Oral Minoxidil has a black box warning because it is a powerful antihypertensive agent that can produce serious adverse effects. Serious cardiovascular side effects have been demonstrated in clinical trials 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 reduce adverse cardiovascular effects.
Minoxidil can cause pericardial effusion (accumulation of too much fluid around the heart), which can progress to tamponade, increasing pressure on the heart and preventing it from beating properly. Symptoms include sharp chest pain and difficulty breathing. Seek emergency treatment immediately if this occurs.
Minoxidil can increase your heart rate and cause or worsen chest pain (angina). If you have new or worsening pain in the chest, arm, or shoulders, tell your doctor right away.
Minoxidil can cause poor heart function or worsen existing heart problems like heart failure. Patients with malignant hypertension should be hospitalized when Minoxidil is first administered.
Do not use Minoxidil if you are allergic to it, or if you have a pheochromocytoma (tumor of the adrenal gland). Do not use topical Minoxidil if you have active skin abrasions, open wounds, psoriasis, or sunburn.
Do not take Minoxidil with guanethidine, sildenafil, or tadalafil. Minoxidil may interact with other medications that affect blood pressure or heart function. Always inform your provider of all medications you are taking.
Salt and water retention: If you quickly gain five or more pounds, or if there is any swelling or puffiness in the face, hands, ankles, or stomach area, contact your provider immediately.
Increased heart rate (tachycardia): If you have an increase of 20 beats or more per minute over your normal pulse, or experience new or worsening chest pain, contact your provider immediately or seek urgent care.
Pericarditis, Pericardial Effusion, and Tamponade: Monitor for sharp chest pain, arm, or shoulder pain, signs of severe indigestion, or shortness of breath, dizziness, lightheadedness, and fainting. Seek immediate emergency care.
Rapid blood pressure drop: A sudden drop in blood pressure can lead to fainting, heart attack, and loss of blood flow to certain organs. Monitor your blood pressure closely when starting oral Minoxidil or changing dosing.
Minoxidil is pregnancy category C. Its safety in pregnant women has not been fully established. It should be avoided by women who are pregnant, planning pregnancy, or breastfeeding. Do not use topical Minoxidil if you have active skin abrasions, as this increases risk for systemic absorption.
The above does not encompass all potential side effects, medication interactions, or studies related to Minoxidil. For a comprehensive overview, review the FDA prescribing information:
FDA Prescribing Information (Minoxidil) · MedlinePlus Drug Information
If you experience severe symptoms or are having a medical emergency, call 911 or seek immediate medical attention.