What is Grower?

Grower is a compounded medication combining three active ingredients: minoxidil, tadalafil, and biotin. It is intended only for men 18 years and older for the treatment of male pattern hair loss AND erectile dysfunction.

Important: Grower is a compounded medication. Although its ingredients have been FDA-approved for other uses, Grower itself is NOT FDA-approved and has not been reviewed by the FDA for safety, effectiveness, or quality for any use.

• Minoxidil is FDA-approved as a blood pressure medication and as a topical treatment for hair loss. However, oral minoxidil (as used in Grower) is NOT FDA-approved for hair loss—it is used "off-label" for this purpose.
• Tadalafil is FDA-approved to treat erectile dysfunction and enlarged prostate symptoms (BPH).
• Biotin (Vitamin B7) is a vitamin supplement included to support hair health.

Note: This summary does not contain all possible safety information. It is not a substitute for advice from your healthcare provider. Always talk to your doctor or pharmacist before taking this medication.

Who Should NOT Take Grower

Do not take Grower if you:

• Have a pheochromocytoma (a rare tumor of the adrenal gland)
• Are taking any form of nitrates (often prescribed for chest pain/angina, such as nitroglycerin)—this combination can cause a dangerous drop in blood pressure
• Have had a serious allergic reaction to minoxidil, tadalafil, or biotin in the past
• Have had a heart attack within the past month

Important Warnings

Heart and Blood Pressure Concerns

IMPORTANT CARDIOVASCULAR WARNING

Oral minoxidil is a powerful blood pressure medication that can cause serious side effects related to your heart and blood pressure. These effects are typically managed when used for high blood pressure but require awareness when used for hair loss.

Fluid Retention (Salt and Water Buildup)

• Grower can cause your body to retain fluid.
• Contact your doctor immediately if you experience:
  • Rapid weight gain (5 or more pounds quickly)
  • Swelling or puffiness in your face, hands, ankles, or stomach

Increased Heart Rate

• Grower can make your heart beat faster.
• Check your resting pulse regularly.
• Contact your doctor immediately if your pulse increases by 20 or more beats per minute above normal.

Serious Heart Problems

• In rare cases, oral minoxidil can cause fluid buildup around the heart (pericardial effusion), which can become life-threatening.
• Seek emergency medical care immediately if you experience:
  • Sharp pain in your chest, arm, or shoulder
  • Severe indigestion-like symptoms
  • Shortness of breath
  • Dizziness, lightheadedness, or fainting

Blood Pressure Drop

• Grower can lower your blood pressure, sometimes too quickly.
• A sudden drop in blood pressure can cause fainting or reduce blood flow to vital organs.
• Do not take Grower if sexual activity is risky for your heart.

Additional Blood Pressure Warnings:

• Taking Grower with alpha-blockers (medications for high blood pressure or prostate issues), other blood pressure medications, or more than 5 alcoholic drinks can cause a dangerous drop in blood pressure.

Vision and Hearing

• Stop taking Grower and get medical help right away if you experience sudden vision loss in one or both eyes.
• Stop taking Grower and get medical help right away if you experience sudden hearing loss or ringing in your ears.

Prolonged Erection

• Seek emergency medical care if you have an erection lasting more than 4 hours. This condition (priapism) can cause permanent damage if not treated promptly.

Biotin and Lab Tests

• Biotin can interfere with certain laboratory tests, including tests used to diagnose heart attacks.
• Tell your doctor and lab technicians that you are taking biotin before any blood tests.
• Do not take additional biotin supplements without consulting your healthcare provider.

Other Precautions

Talk to your doctor before taking Grower if you have:

• Heart disease or a history of heart problems
• A history of heart attack (do not use within one month of a heart attack)
• High or low blood pressure
• A history of priapism (prolonged erections)
• A previous episode of sudden vision loss (NAION)
• Kidney problems or are on dialysis
• Liver problems

Cannabis Warning

Avoid concurrent use of cannabis products, as they may slow the breakdown of your medication and increase side effects.

Drug Interactions

Tell your doctor about all medications you take, especially:

Common Side Effects

From Minoxidil:

• Increased hair growth on face or body (hypertrichosis)
• Lightheadedness
• Rapid or pounding heartbeat
• Headache
• Swelling in legs, ankles, or around eyes
• Trouble sleeping
• Nausea or bloating
• Flushing

From Tadalafil:

• Headache
• Indigestion or upset stomach
• Back pain
• Muscle aches
• Stuffy nose
• Flushing (warmth or redness in face/neck)
• Pain in arms or legs

Rare but Serious Side Effects

Seek medical attention if you experience:

• Hallucinations or confusion
• Agitation or unusual excitement
• Severe allergic reaction (swelling of face/lips/tongue/throat, difficulty breathing, hives)
• Rapid heartbeat
• Difficulty breathing
• Eye pain or vision changes (may indicate glaucoma)
• Suicidal thoughts or worsening depression
• Complex sleep behaviors (sleepwalking, sleep-driving, etc.)

Special Populations

This medication is NOT for:

• Women
• Anyone under 18 years old
• Pregnant or breastfeeding individuals (minoxidil can harm the baby and passes into breast milk)
• Anyone who has had a heart attack within the past month

Use with caution if you have:

• Kidney problems or on dialysis: Dose adjustment may be needed; limited use for severe kidney disease
• Liver problems: Dose adjustment may be needed for tadalafil; not recommended for severe liver disease

Reporting Side Effects

If you experience any serious or unexpected side effects, report them to the FDA:

• Phone: 1-800-FDA-1088
• Online: www.fda.gov/medwatch