Finasteride safety information

Finasteride is for use by ADULT MEN ONLY and should NOT be used by women or children.

Do not take finasteride if you:

• are pregnant or may become pregnant. Finasteride may harm your unborn baby. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed finasteride tablets. If a pregnant woman comes in contact with crushed or broken finasteride tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in finasteride (for example from a crushed or broken tablet), a healthcare provider should be consulted. If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in finasteride, the male baby may be born with sex organs that are not normal.
• are allergic to any of the ingredients in finasteride.

What should I tell my healthcare provider before taking finasteride?

Before taking finasteride, tell your healthcare provider if you:

• have any other medical conditions, especially problems with your prostate or liver
• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm.

How should I take finasteride?

• Take finasteride exactly as your healthcare provider tells you to take it.
• You may take finasteride with or without food.
• If you forget to take finasteride, do not take an extra tablet. Just take the next tablet as usual.You may take finasteride with or without food.
• Finasteride will not work faster or better if you take it more than once a day.

Side Effects of Finasteride

Finasteride can have the following side effects:

• Decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride can affect a blood test called PSA (Prostate-Specific Antigen), which is used as a screening test for prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking finasteride because finasteride decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking finasteride. You should also tell your healthcare provider if you have not been taking finasteride as prescribed because this may affect the PSA test results. For more information, talk to your healthcare provider.
• There may be an increased risk of a more serious form of prostate cancer. In studies, this was found in men taking finasteride at 5 mg. Which is 5 times the dose used for hair loss.

The most common side effects of finasteride include:

• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen

The following have been reported in general use with finasteride:

• Breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge
• Depression
• Decrease in sex drive that continued after stopping the medication;
• Allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face;
• Problems with ejaculation that continued after stopping medication;
• Testicular pain;
• Difficulty in achieving an erection that continued after stopping the medication;
• Male infertility and/or poor quality of semen.
• In rare cases, male breast cancer. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of finasteride. For more information, ask your healthcare provider or pharmacist.

Keep finasteride and all medicines out of the reach of children. Do not give finasteride to other people, even if they have the same symptoms you have. It may harm them.

Finasteride Oral vs Finasteride Topical

Oral finasteride 1 mg is one of two FDA-approved treatments for male pattern hair loss, the other one being topical minoxidil 2% or 5%. Since oral finasteride has been shown to cause sexual side effects in a small number of men (3.8% of men who took finasteride vs 2.1% of men who took placebo in phase III clinical trials for finasteride), researchers have been interested in whether topical finasteride applied to the scalp may be effective in treating male pattern hair loss with a lower potential for side effects.

A 2018 systematic review of the results of seven different studies concluded that topical finasteride is effective for the treatment of male pattern hair loss but also lowers plasma (blood) DHT levels which can lead to undesired side effects like low libido. Still, it appears that the incidence of side effects was lower with topical finasteride than oral finasteride. Also, some researchers found that plasma DHT levels were only minimally decreased with topical finasteride.

At this time, topical finasteride is not FDA-approved for the treatment of male pattern hair loss and must be specially compounded by a compounding pharmacy and requires a doctor’s prescription. For this reason, compounded topical finasteride is not available through Roman.

Can You Get Finasteride without a Prescription?

In the United States, finasteride, whether oral or topical, is not available without a prescription from a healthcare practitioner. Oral finasteride in the 1 mg and 5 mg doses are FDA-approved medications to treat male pattern hair loss and the symptoms of BPH, respectively. Topical finasteride is not FDA-approved and can be made by compounding pharmacies but still requires a prescription. There may be sellers who advertise finasteride online without a prescription, but these are not recommended as they may not be regulated for purity of ingredients, efficacy, or safety.