What is the black box warning for minoxidil?

Author: Miss Aimee Jacobson  |  Last update: Monday, November 17, 2025

In the United States, the Food and Drug Administration issued a black-box warning for pericardial effusion, cardiac tamponade, and electrocardiogram (EKG) changes for oral minoxidil therapy. The potential for these adverse events explains its indication for only severe, treatment-resistant hypertension.

Why is minoxidil not recommended?

Contraindications include the following: Minoxidil should not be used in patients with a known history of hypersensitivity to the drug or its constituents, including propylene glycol. The utilization of minoxidil is not recommended for pregnant and breastfeeding women.

Is minoxidil 100% safe?

Do not use this medication more often, apply more of it than as directed, or apply it to an irritated or sunburned scalp. Doing so can cause the drug to be absorbed into your body and result in serious side effects. This product may contain alcohol and can be irritating and drying to the scalp.

Is oral minoxidil hard on the kidneys?

The maximum recommended dose of oral Minoxidil is 100mg/day. Our patient consumed approximately 1500mg. Minoxidil has been known to cause transient increases in creatinine and blood urea nitrogen, generally resolved with supportive care. Long term studies have shown that minoxidil can cause irreversible kidney damage.

What is the problem with minoxidil?

It comes as a foam and as a liquid solution. Topical minoxidil is generally well tolerated, but it can cause temporary hair shedding, scalp irritation, and changes in hair texture. In rare cases, it can contribute to a fast heartbeat. Some minoxidil side effects can be avoided by taking the low-dose tablet formulation.

Oral Minoxidil - 12 Months UPDATE!

Why people stop using minoxidil?

You have significant side effects. It's expensive to continue using Minoxidil every day. You're concerned that Minoxidil is interacting with other medications you're taking. You've achieved the results you want and no longer want to use Minoxidil.

What does minoxidil do to your heart?

Minoxidil overdose can cause a broad range of serious cardiovascular side effects, including severe circulatory shock due to its direct vasodilatory effect, fluid retention, pulmonary edema, tachycardia-induced acute heart failure, and subendocardial ischemia.

Why can't over 65s use minoxidil?

As the skin's characteristics and responses can alter with age, older adults over 65 may experience different results or an increased risk of side effects. Despite its topical application, a small amount of Minoxidil can be absorbed by the body, potentially affecting blood pressure and overall cardiovascular function.

Is minoxidil toxic to the liver?

Hepatotoxicity. Serum aminotransferase elevations during oral minoxidil therapy are uncommon, but have been reported even with topical administration. Despite many decades of use, oral minoxidil has not been implicated in convincing cases of clinically apparent acute liver injury.

Why does minoxidil cause weight gain?

It may cause weight gain due to water retention in the body.

Is rosemary oil better than minoxidil?

Rosemary oil is preferred by people who prefer a natural approach and have modest hair thinning, but minoxidil is preferred by users looking for a more potent, clinically confirmed therapy for advanced hair loss. Many consumers find success with one product over another, and some even combine them to maximize benefits.

What drugs should not be taken with minoxidil?

List of interactions for Minoxidil
  • Acebutolol. Both Minoxidil and Acebutolol can increase the risk of hypotension.
  • Alcohol. Both Minoxidil and Alcohol can increase the risk of hypotension.
  • Alfuzosin. Both Minoxidil and Alfuzosin can increase the risk of hypotension.
  • Aliskiren. ...
  • Alprostadil. ...
  • Amantadine. ...
  • Amitriptyline. ...
  • Amlodipine.

Does Costco have minoxidil?

Kirkland Signature Hair Regrowth Treatment Minoxidil Foam for Men, 2.11 oz, 6-count | Costco.

Does oral minoxidil age your face?

It's certainly premature to jump to conclusions that minoxidil promotes facial aging. If it does, it's rare - likely because not enough minoxidil reaches the facial skin.

Does minoxidil cause ED?

Some men taking minoxidil have reported sexual side effects such as erectile dysfunction (ED) and decreased libido.

Who Cannot use minoxidil?

Before using minoxidil,

tell your doctor if you have or have ever had heart, kidney, liver, or scalp disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using minoxidil, call your doctor.

What is the major side effect of minoxidil?

Tell your doctor if you notice continued itching, redness, or burning of your scalp after you apply minoxidil. If the itching, redness, or burning is severe, wash the medicine off and check with your doctor before using it again. Hair loss may continue for 2 weeks after you start using minoxidil.

Does minoxidil damage collagen?

While minoxidil itself does not directly break down collagen, some research suggests that its long-term use may contribute to increased oxidative stress in the skin.

Is minoxidil a carcinogen?

Minoxidil is a cosmetic drug that is recognized as a mitogenic agent, and mitogens are suggested to have carcinogenic and mutagenic potential by inducing cell division and increasing the possibility of perpetuating DNA damage.

Can a 70 year old woman regrow hair?

Over time, hair fibers become thinner and drop out, and unfortunately, they never regenerate. Natural pigment (color) changes occur in hair as you age as well. Pigment cells stop producing as much, and eventually, your once thick, chestnut hair becomes thin, fine and gray.

Does rosemary oil grow hair?

The overall result of the study provided evidence that rosemary oil may be effective for certain hair growth. A study from 2022 also found evidence that rosemary oil can aid in hair growth. The study stated that rosemary oil had the same effect as Minoxidil, a hair growth medication, after 6 weeks of use.

Does minoxidil cause weight gain?

While you are taking minoxidil, weigh yourself every day. A weight gain of 2 to 3 pounds (about 1 kg) in an adult is normal and should be lost with continued treatment.

Does topical minoxidil get into the bloodstream?

Systemic absorption of topical minoxidil is less than 99% of the amount applied on the scalp. Minoxidil does not bind to plasma proteins or crosses the blood–brain barrier. Approximately 95% of the systemically absorbed drug and its metabolites are excreted via the kidney within 4 days.

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