A Clinical Look at Telehealth: Is Hims Actually Safe?

In 2021, 37% of U.S. adults used telemedicine, a trend that has driven the growth of platforms like Hims [1.7.1]. But with convenience comes questions, chief among them: Is Hims actually safe for obtaining prescription medications?

Quick Summary

Hims offers legitimate, FDA-approved medications through licensed physicians. However, the safety depends on accurate patient self-reporting, understanding potential side effects, and awareness of issues like FDA warnings on compounded drugs.

Key Points

• Licensed Professionals: Hims connects users with board-certified physicians who are licensed to prescribe medication in their state [1.2.2, 1.5.1].

• FDA-Approved Ingredients: The platform primarily uses active ingredients like sildenafil and finasteride that are FDA-approved and have a long history of clinical use [1.2.2, 1.2.5].

• Patient Responsibility: Safety is highly dependent on the user providing accurate and complete medical information during the online consultation process [1.2.2].

• Risk of Side Effects: All medications have potential side effects; for instance, PDE5 inhibitors can affect blood pressure, and finasteride has been linked to sexual and mental health side effects [1.2.2, 1.2.3].

• Compounded Drug Concerns: Hims offers compounded medications which are not individually FDA-approved, and the company received an FDA warning for misleading claims about these products [1.9.3, 1.9.5].

• HIPAA Compliance: Hims is required to protect patient medical information under HIPAA, but like many websites, it tracks user browsing behavior for marketing [1.2.2, 1.6.2].

• No Substitute for In-Person Care: The telehealth model is not suitable for all medical issues and cannot replace a comprehensive physical exam or a long-term doctor-patient relationship [1.2.3].

The Rise of Telehealth and Hims

Telehealth services have surged in popularity, offering unprecedented convenience for accessing medical care. In 2021, over one-third of American adults utilized telemedicine services [1.7.1]. Hims is a prominent direct-to-consumer (DTC) telehealth company that has capitalized on this trend, focusing on men's health issues like erectile dysfunction (ED), hair loss (androgenetic alopecia), and mental health [1.2.2].

The platform operates on a simple model: patients complete an online questionnaire, a licensed medical provider reviews their information, and if appropriate, a prescription is issued and shipped directly to the patient [1.5.1]. This process is designed to be discreet and remove the potential discomfort of in-person consultations for sensitive conditions [1.2.2]. While Hims employs board-certified doctors licensed to practice in the states they serve, the safety of this model hinges on several critical factors, including patient honesty, the limitations of remote diagnosis, and the nature of the medications themselves [1.2.2, 1.5.1].

Medications, Pharmacology, and Safety

Hims primarily offers well-established, FDA-approved medications. The safety of these drugs is well-documented through extensive clinical research [1.2.2].

For Erectile Dysfunction (ED):

• Sildenafil (generic Viagra), Tadalafil (generic Cialis), Vardenafil, and Avanafil (Stendra): These are phosphodiesterase-5 (PDE5) inhibitors [1.2.2]. They work by increasing blood flow to the penis following sexual stimulation. By inhibiting the PDE5 enzyme, they allow cyclic guanosine monophosphate (cGMP) to accumulate, which relaxes smooth muscles and widens blood vessels [1.2.2].
• Common Side Effects: Headache, facial flushing, nasal congestion, indigestion, and muscle pain are common [1.2.2]. A significant risk involves their effect on blood pressure; they can cause dangerous drops in blood pressure, especially when taken with nitrates or by individuals with pre-existing cardiovascular conditions. Hims requires users to submit a recent blood pressure reading before a prescription is approved [1.2.2].

For Hair Loss:

• Finasteride: This oral medication is FDA-approved to treat male pattern baldness [1.2.4]. It works by blocking the enzyme 5-alpha-reductase, which converts testosterone to dihydrotestosterone (DHT), a hormone that shrinks hair follicles [1.2.4].
• Minoxidil: A topical treatment (also the active ingredient in Rogaine) that is also FDA-approved [1.2.1]. Its exact mechanism is not fully understood, but it's believed to be a vasodilator that may improve follicle function and stimulate hair growth.
• Side Effects and Warnings: While generally considered safe, finasteride carries risks. In April 2025, the FDA issued a warning about topical finasteride after reports of side effects including depression, dizziness, and low libido [1.2.3]. Hims has described the side effects of its topical version as "minimal," which highlights a point of contention regarding patient awareness and informed consent in a telehealth setting [1.2.3]. Common side effects of minoxidil include scalp irritation and unwanted facial hair growth [1.2.1].

Regulatory Scrutiny and Compounded Medications

A key area of concern involves compounded medications. These are custom-formulated drugs mixed by a pharmacy, which are not themselves FDA-approved, even if their active ingredients are [1.2.2]. Hims has heavily marketed compounded products, such as chewable ED medications and multi-ingredient topical formulas [1.4.2].

In September 2025, the FDA sent a warning letter to Hims & Hers, stating the company made "false or misleading claims" about its compounded semaglutide products (the active ingredient in Ozempic and Wegovy) [1.9.5, 1.9.2]. The FDA noted that Hims' marketing implied its products were the same as the FDA-approved brand-name drugs when they are not [1.4.4, 1.9.3]. This regulatory action underscores the risks associated with compounded drugs, which may have issues with purity or potency [1.4.3]. The Better Business Bureau (BBB) profile for Hims & Hers Inc. shows an A+ rating but also includes complaints related to billing and cancellation issues [1.8.5, 1.8.2].

Comparison: Hims vs. Roman vs. Traditional Care

The telehealth landscape includes several key players, with Roman being a primary competitor to Hims. Both operate on a similar DTC model, connecting patients with licensed physicians for a limited set of conditions [1.5.1, 1.5.2].

Feature	Hims	Roman	Traditional In-Person Care
Convenience	High: Asynchronous online consults, direct shipping [1.2.2].	High: Similar online model, fast shipping [1.5.5].	Low: Requires scheduling, travel, and pharmacy visits.
Cost	Generally lower for generic drugs compared to traditional care; offers multiple billing cycles [1.2.2]. Often slightly cheaper than Roman [1.5.3].	Transparent pricing but often slightly higher than Hims for many products [1.5.3].	Varies widely based on insurance coverage; can be higher for uninsured patients.
Scope of Care	Limited to specific conditions (ED, hair loss, mental health, etc.) [1.2.2].	Also limited to a specific set of conditions, similar to Hims [1.5.4].	Comprehensive: Full physical exams, diagnostic testing, management of complex conditions.
Physician Relationship	Transactional; communication is typically through a messaging portal [1.2.2].	Similar to Hims, with a focus on messaging-based communication [1.5.5].	Continuous; allows for a long-term relationship and holistic health overview [1.2.3].
Privacy	HIPAA-compliant for medical data, but uses website tracking for marketing like other retail sites [1.2.2, 1.6.2].	HIPAA-compliant; similar use of web tracking data [1.5.5, 1.6.2].	High, governed strictly by HIPAA in a controlled environment.

Conclusion

So, is Hims actually safe? The answer is nuanced. The platform provides access to legitimate, FDA-approved medications prescribed by licensed doctors for specific, well-defined conditions [1.2.2, 1.5.1]. For many men, it represents a convenient, private, and effective way to receive treatment [1.2.2].

The primary risks do not stem from the medications themselves—which are the same drugs prescribed in traditional settings—but from the telehealth model's limitations. Safety relies heavily on the patient's ability to provide a complete and accurate medical history without a physical examination. Furthermore, recent FDA actions against Hims for its marketing of compounded drugs highlight a significant concern [1.9.1]. Patients may not fully understand that these formulations are not FDA-approved and may carry different risks [1.4.4]. While Hims is a legitimate medical provider, patients must be proactive, read all information carefully, and understand that for complex health issues, nothing replaces a comprehensive, in-person consultation with a primary care physician.

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Authoritative Link: Telehealth Privacy and Security Tips for Patients from HHS.gov [1.6.4]

Frequently Asked Questions

Are the doctors on Hims real and licensed?

Yes, Hims uses board-certified doctors and medical providers who are fully licensed to practice and prescribe medications in the states where they provide care [1.2.2, 1.5.1].

Are Hims medications FDA-approved?

Hims primarily prescribes medications whose active ingredients (like sildenafil for ED or finasteride for hair loss) are FDA-approved [1.2.5]. However, some of their products are 'compounded'—custom-mixed formulations that are not themselves directly approved by the FDA [1.2.2].

What are the main safety risks with using Hims?

The main risks include potential medication side effects, the possibility of misdiagnosis due to the lack of a physical exam, and reliance on patient self-reporting. There are also concerns around compounded drugs, for which Hims has received an FDA warning for its marketing claims [1.2.2, 1.9.5].

Can I use Hims if I have other health conditions?

It is critical to disclose all health conditions and current medications during your Hims consultation. For example, PDE5 inhibitors for ED can be dangerous for men with certain heart conditions or those taking nitrate drugs [1.2.2].

Has Hims faced any regulatory issues?

Yes. In September 2025, the U.S. FDA sent a warning letter to Hims & Hers for making what it called "false or misleading claims" about its compounded weight-loss drugs [1.9.1, 1.9.5].

Is my personal information safe with Hims?

Your medical data is protected under HIPAA laws, just like at a traditional doctor's office [1.6.2]. However, the company's website does use cookies and tracking technology for advertising and analytics, which is a common practice for online businesses [1.2.2].

How does Hims compare to seeing my own doctor?

Hims offers more convenience and privacy for specific conditions but lacks the comprehensive care of a traditional doctor, who can perform physical exams and manage your overall health. For complex health issues, an in-person visit is recommended [1.2.3].