Journal of Urology and Research

Rates of Patient-Reported Side Effects for PDE5 Inhibitors Prescribed on a Direct-to-Consumer Telehealth Platform

Short Communication | Open Access Volume 7 | Issue 2 |

  • 1. Ro, New York, USA
  • 2. Department of Urology, Stanford University School of Medicine, USA
+ Show More - Show Less
Corresponding Authors
Lauren Broffman, Ro, New York, 116 West 23rd Street, 4th Floor, New York, NY 10011, USA, Tel: 7167134178; Email: Lauren.broffman@ro.co

Direct-to-consumer telehealth is becoming increasingly common for the treatment of erectile dysfunction, but little is known about rates of side effects for patients being treated with prescription medication through these platforms. In this study, EHR and customer service data from a random sample of 10,000 DTC erectile dysfunction telehealth patients receiving treatment on one of the largest telehealth platforms in the U.S. was analyzed for instances of patients’ experiencing side effects. We report the incidence rate of patientreported side effects for sample patients that were prescribed PDE5 inhibitors and compared them to published literature. Rates of side effects were much lower than what was reported in clinical trials, but they align with published rates of discontinued use. Further, the distribution of the kinds of side effects experienced reflects results from other studies. Findings suggest that the experience of side effects is not drastically different for patients being treated on a DTC telehealth platform than in other settings. Similar distribution and rates of side effects for men most bothered these medications indicates that treatment for ED on a DTC telehealth platform does not lead to unsafe, or even unexpected, numbers of experienced side effects.


Erectile dysfunction, Telehealth, PDE5 inhibitors, Side effects, Health technology


Broffman L, Eisenberg M, Barnes M (2020) Rates of Patient-Reported Side Effects for PDE5 Inhibitors Prescribed on a Direct-to-Consumer Telehealth Platform. J Urol Res 7(2): 1122.


DTC: Direct to Consumer; PDE5: oral phosphodiesterase type 5; ED: Erectile Dysfunction; EHR: Electronic Health Record


The medical community has begun to debate the implications of direct-to-consumer (DTC) telehealth, especially in light of its proliferation during the COVID-19 pandemic as a crucial delivery platform for essential health care. Research has shown that patient satisfaction with DTC telehealth is high, [1] and evidence is emerging that certain conditions can be effectively managed in this way [2,3]. However, uncertainties remain: a recent editorial published in the Journal of the American Medical Association (JAMA) notes positives of the DTC health care model, including increased access and decreased costs but also flags the lack of literature on “the prevalence of adverse events related to the sale of prescription drugs [4].”

One organization operating a DTC telehealth platform is Ro. a U.S.-based DTC health company whose digital health clinic for men, Roman, offers treatment for men with erectile dysfunction (ED). With recent reports citing a current valuation of 1.5 billion dollars [5], they are one of the largest and most prominent players in the DTC health care space. Patients seeking ED treatment on Ro’s platform start by engaging in an adaptive online intake process that captures their demographics, current symptoms, health history, and other relevant clinical information in a structured format. Depending on their preference and/or state laws regulating telehealth, patients are then connected to a U.S. licensed provider via video call, phone call, or through the secure, asynchronous exchange of medical information and messages.”

Their Ro-affiliated provider then determines which, if any, course of treatment is appropriate. Following their visit, patients are able to communicate continuously with their physician over Ro’s secure platform. Patients are able to ask questions, and, if necessary, report side effects.

Given the noted literature gap on relative prevalence rates of reported side effects from medication prescribed on a DTC telehealth platform, a team of researchers at Ro analyzed electronic health record (EHR) and customer service data on men that were prescribed treatment for ED. The aim of this study, the first of its kind in DTC telehealth platform, is to compare rates of patient-reported side effects from medication prescribed on a DTC telehealth platform to existing research on rates of side effects reported via clinical studies.


The design of this study was approved by the Biomedical Research Association of New York Institutional Review Board. To assess rates of side effects prescribed via telehealth, we randomly selected 10,000 men from a larger pool of patients who were treated virtually on Ro’s DTC telehealth platform starting in 2018. This ensured that patients had been taking medication long enough for any possible side effects to arise. We limited the sampling frame to those who were prescribed one of the two most commonly prescribed medications used in ED treatment, and randomly selected 5,000 patients that were prescribed tadalafil (the active ingredient in Cialis) and 5,000 that were prescribed sildenafil (the active ingredient in Viagra). These medications are classified as oral phosphodiesterase type 5 (PDE5) inhibitors, the standard pharmacologic treatment for ED. Patients taking these medications were selected because their use is widespread and rates of side effects for both sildenafil and tadalafil are wellstudied, allowing us to compare rates of side effects reported on Ro’s platform to rates of side effects published in the literature.

We assessed rates of patient-reported side effects by analyzing two sets of records. We define “patient reported” as an unprompted communication initiated by the patient to inform either their Ro-affiliated provider or Ro’s patient relations team that they experienced a side effect from a prescribed medication. To do this, we first reviewed messages between patients and their Ro-affiliated providers from initial treatment sometime in 2018 through September 2019. This chat interaction data undergoes consistent quality review every two weeks by a quality assurance team to ensure that it accurately reflects the information exchanged between a given patient and their provider. To ensure that the data was extracted correctly from the database, the SQL code used to pull the study sample underwent a standard verification process in which the pull was repeated by a second analyst and assessed for overlap. To further ensure that all side effects experienced by patients in the sample were accurately captured, we then reviewed a second set of data: separate records maintained by Ro’s patient relations team tracking patients who contacted them with medical questions. We found there were no instances of side effects reported to the patient relations team that were not relayed to the provider, who then followed up with patients. Thus, reports of side effects captured in patient relations team data were also consistently reflected in our main data source, the patient-provider messages.

To analyze the rates of patient-reported side effects, a PhD level scientist reviewed the text exchange for each patient in the sample, flagging any records where patients reported side effect, and categorized the side effect by type. Most were obvious, e.g., “the medication gave me a headache.” Less-than-clear reports were discussed by the research team with a Ro physician researcher adjudicating final decisions.


Overall, 1.4% of patients reported a side effect from a PDE5 inhibitor: 1.8% of patients taking sildenafil, and 1.0% of patients taking tadalafil (Table 1),

Table 1: Patient-reported side effects from PDE5 inhibitors prescribed via telehealh.


% Overall (n)

% Sildenafil group (n)

% Tadalafil group (n)

Any side effect

1.4 (143)

1.8 (92)

1.0 (50)


47.9 (68)

55.7 (44)

55.8 (24)


23.2 (33)

34.2 (27)

14.0 (6)


20.4 (29)

26.6 (21)

18.6 (8)


12.0 (17)

13.9 (11)

14.0 (6)

Vision-related (blurring/itchiness in eyes)

6.3 (9)

10.1 (8)

2.3 (1)

Back or muscle pain

4.9 (7)

1.3 (1)

11.6 (5)


2.1 (3)

0.0 (0)

7.0 (3)


4.2 (6)

3.8 (3)

7.0 (3

with headache, flushing, rhinitis, and dyspepsia being the most common. Side effects in the “other” category include rashes and ringing in ears for tadalafil and bloody stools for sildenafil. We also observed that most patients (>90%) who initiated a conversation with their Ro-affiliated provider to report side effects requested and received a change in dose or medication.

This study represents the first published set of data from a large DTC telehealth platform on medication side effects. Of note, our results are derived from proactive patient reports in a real-world setting rather than trial-directed protocols of standardized adverse event collection. Because of this, our study unsurprisingly shows that the incidence of reported side effects are significantly lower than rates from clinical trials [6,7]. However, the distribution of side effects types observed is consistent with the reported literature: headaches, dyspepsia, flushing, and rhinitis are the most common [8,9].

Notably, our overall incidence rates are similar to published rates of discontinued use due to side effects for both drugs (0-6%), [8-10], aligning with our observation that proactive patient side effect reporting was accompanied by requests for prescription changes, i.e., discontinued use. More patients may have experienced mild side effects tolerable enough to not report and continued use of the medication at current dosages. Though the purpose of this study was not to compare rates of side effects for sildenafil and tadalafil, we note that the overall side effect rate was higher in sildenafil, which contradicts some comparative studies of both drugs [11].

One of the limitations of this study is that we cannot be entirely certain that a patient who experienced an intolerable side effect communicated it to their Ro-affiliated provider or the patient relations team, and thus it is possible that the incidence rate of side effects is artificially low. However, it is not uncommon in the in-person care system for a provider to be unaware when their patient receives care in other settings, so this limitation is not unique to a telehealth setting. Further, these results might not be generalizable to other DTC telehealth platform or telehealth more broadly.


More research is needed on the association of telehealth platforms and side effects for other prescription drugs. Limitations notwithstanding, similar distribution and rates of side effects for men most bothered by either sildenafil or tadalafil suggests that treatment for ED on a DTC telehealth platforms1) does not lead to unsafe, or even unexpected, numbers of experienced side-effects; and, 2) supports prompt and coordinated physician responses to requests for medication changes when intolerable levels of side effects do occur. Further, structured renewal visits that prompt patients to report any side effects and automated data collection of DTC telehealth platforms, like Ro, provide numerous opportunities beyond traditional treatment models for understanding treatment side effects and improving patient safety.


We are indebted to Ro employees Kevin Stern for the aggregation and cleaning of electronic health record data, and to Adam Greenberg, Amy Westergren, Meghan Pianta, Dr. Tzvi Doron, and Zachariah Reitano for their feedback on the manuscript.


No direct funding was supplied for this study; however, the study was conducted at Ro, with whom all three authors are affiliated. As Drs. Broffman and Barnes are directly employed by Ro and were engaged at all levels of the study, Ro, as the de-facto sponsor organization, was involved in the design and conduct of the study, collection, management, and analysis of data, preparation, review and approval of the manuscript, and the decision to submit for publication.

Dr. Broffman is a full-time employee at Ro and has stock options in the company

Dr. Eisenberg serves as an unpaid advisor on Ro’s medical advisory board and has stock options in the company

Dr. Barnes is a full-time employee at Ro


1. Polinski JM, Barker T, Gagliano N, Sussman, Brennan TA, Shrank WH. Patients’ Satisfaction with and Preference for Telehealth Visits. Journal of general internal medicine. 2016; 31: 269-275.

2. Rothberg MB, Martinez KA. Influenza Management via Direct to Consumer Telehealth: an Observational Study. Journal of General Internal Medicine. 2020; 1-3.

3. Rastogi R, Martinez KA, Gupta N. Management of Urinary Tract Infections in Direct to Consumer Telehealth. Journal of general internal medicine. 2019: 1-6.

4. Jain T, Lu RJ, Mehrotra A. Prescriptions on Demand: The Growth of Direct-to-Consumer Telehealth Companies. Jama. 2019; 322: 925-926.

5. Farr C. Ro, a 3-year-old online health provider, just raised a new round that values it at $1.5 billion

6. . 2020.

7. Coward RM, Carson CC. Tadalafil in the treatment of erectile dysfunction. Therapeutics and clinical risk management. 2008; 4: 1315.

8. Moore R, Edwards J, McQuay H. Sildenafil (Viagra) for male erectile dysfunction: a meta-analysis of clinical trial reports. BMC Urology. 2002; 2: 6.

9. Moore RA, Derry S, McQuay HJ. Indirect comparison of interventions using published randomised trials: systematic review of PDE-5 inhibitors for erectile dysfunction. BMC Urology. 2005; 5: 18.

10.McMurray JG, Feldman RA, Auerbach SM. Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. Therapeutics and clinical risk management. 2007; 3: 975.

11.Moreira Jr SG, Brannigan RE, Spitz A, Orejuela FJ, Lipshultz LI, Kim ED. Side-effect profile of sildenafil citrate (Viagra) in clinical practice. Urology. 2000; 56: 474-476.

12.von Keitz A, Rajfer J, Segal S, Murphy A, Denne J, Costigan T, et al. A multicenter, randomized, double-blind, crossover study to evaluate patient preference between tadalafil and sildenafil. European urology. 2004; 45: 499-509.

Broffman L, Eisenberg M, Barnes M (2020) Rates of Patient-Reported Side Effects for PDE5 Inhibitors Prescribed on a Direct-to-Consumer Telehealth Platform. J Urol Res 7(2): 1122.

Received : 04 Aug 2020
Accepted : 30 Sep 2020
Published : 02 Oct 2020
Annals of Otolaryngology and Rhinology
ISSN : 2379-948X
Launched : 2014
JSM Schizophrenia
Launched : 2016
Journal of Nausea
Launched : 2020
JSM Internal Medicine
Launched : 2016
JSM Hepatitis
Launched : 2016
JSM Oro Facial Surgeries
ISSN : 2578-3211
Launched : 2016
Journal of Human Nutrition and Food Science
ISSN : 2333-6706
Launched : 2013
JSM Regenerative Medicine and Bioengineering
ISSN : 2379-0490
Launched : 2013
JSM Spine
ISSN : 2578-3181
Launched : 2016
Archives of Palliative Care
ISSN : 2573-1165
Launched : 2016
JSM Nutritional Disorders
ISSN : 2578-3203
Launched : 2017
Annals of Neurodegenerative Disorders
ISSN : 2476-2032
Launched : 2016
Journal of Fever
ISSN : 2641-7782
Launched : 2017
JSM Bone Marrow Research
ISSN : 2578-3351
Launched : 2016
JSM Mathematics and Statistics
ISSN : 2578-3173
Launched : 2014
Journal of Autoimmunity and Research
ISSN : 2573-1173
Launched : 2014
JSM Arthritis
ISSN : 2475-9155
Launched : 2016
JSM Head and Neck Cancer-Cases and Reviews
ISSN : 2573-1610
Launched : 2016
JSM General Surgery Cases and Images
ISSN : 2573-1564
Launched : 2016
JSM Anatomy and Physiology
ISSN : 2573-1262
Launched : 2016
JSM Dental Surgery
ISSN : 2573-1548
Launched : 2016
Annals of Emergency Surgery
ISSN : 2573-1017
Launched : 2016
Annals of Mens Health and Wellness
ISSN : 2641-7707
Launched : 2017
Journal of Preventive Medicine and Health Care
ISSN : 2576-0084
Launched : 2018
Journal of Chronic Diseases and Management
ISSN : 2573-1300
Launched : 2016
Annals of Vaccines and Immunization
ISSN : 2378-9379
Launched : 2014
JSM Heart Surgery Cases and Images
ISSN : 2578-3157
Launched : 2016
Annals of Reproductive Medicine and Treatment
ISSN : 2573-1092
Launched : 2016
JSM Brain Science
ISSN : 2573-1289
Launched : 2016
JSM Biomarkers
ISSN : 2578-3815
Launched : 2014
JSM Biology
ISSN : 2475-9392
Launched : 2016
Archives of Stem Cell and Research
ISSN : 2578-3580
Launched : 2014
Annals of Clinical and Medical Microbiology
ISSN : 2578-3629
Launched : 2014
JSM Pediatric Surgery
ISSN : 2578-3149
Launched : 2017
Journal of Memory Disorder and Rehabilitation
ISSN : 2578-319X
Launched : 2016
JSM Tropical Medicine and Research
ISSN : 2578-3165
Launched : 2016
JSM Head and Face Medicine
ISSN : 2578-3793
Launched : 2016
JSM Cardiothoracic Surgery
ISSN : 2573-1297
Launched : 2016
JSM Bone and Joint Diseases
ISSN : 2578-3351
Launched : 2017
JSM Bioavailability and Bioequivalence
ISSN : 2641-7812
Launched : 2017
JSM Atherosclerosis
ISSN : 2573-1270
Launched : 2016
Journal of Genitourinary Disorders
ISSN : 2641-7790
Launched : 2017
Journal of Fractures and Sprains
ISSN : 2578-3831
Launched : 2016
Journal of Autism and Epilepsy
ISSN : 2641-7774
Launched : 2016
Annals of Marine Biology and Research
ISSN : 2573-105X
Launched : 2014
JSM Health Education & Primary Health Care
ISSN : 2578-3777
Launched : 2016
JSM Communication Disorders
ISSN : 2578-3807
Launched : 2016
Annals of Musculoskeletal Disorders
ISSN : 2578-3599
Launched : 2016
Annals of Virology and Research
ISSN : 2573-1122
Launched : 2014
JSM Renal Medicine
ISSN : 2573-1637
Launched : 2016
Journal of Muscle Health
ISSN : 2578-3823
Launched : 2016
JSM Genetics and Genomics
ISSN : 2334-1823
Launched : 2013
JSM Anxiety and Depression
ISSN : 2475-9139
Launched : 2016
Clinical Journal of Heart Diseases
ISSN : 2641-7766
Launched : 2016
Annals of Medicinal Chemistry and Research
ISSN : 2378-9336
Launched : 2014
JSM Pain and Management
ISSN : 2578-3378
Launched : 2016
JSM Women's Health
ISSN : 2578-3696
Launched : 2016
Clinical Research in HIV or AIDS
ISSN : 2374-0094
Launched : 2013
Journal of Endocrinology, Diabetes and Obesity
ISSN : 2333-6692
Launched : 2013
Journal of Substance Abuse and Alcoholism
ISSN : 2373-9363
Launched : 2013
JSM Neurosurgery and Spine
ISSN : 2373-9479
Launched : 2013
Journal of Liver and Clinical Research
ISSN : 2379-0830
Launched : 2014
Journal of Drug Design and Research
ISSN : 2379-089X
Launched : 2014
JSM Clinical Oncology and Research
ISSN : 2373-938X
Launched : 2013
JSM Bioinformatics, Genomics and Proteomics
ISSN : 2576-1102
Launched : 2014
JSM Chemistry
ISSN : 2334-1831
Launched : 2013
Journal of Trauma and Care
ISSN : 2573-1246
Launched : 2014
JSM Surgical Oncology and Research
ISSN : 2578-3688
Launched : 2016
Annals of Food Processing and Preservation
ISSN : 2573-1033
Launched : 2016
Journal of Radiology and Radiation Therapy
ISSN : 2333-7095
Launched : 2013
JSM Physical Medicine and Rehabilitation
ISSN : 2578-3572
Launched : 2016
Annals of Clinical Pathology
ISSN : 2373-9282
Launched : 2013
Annals of Cardiovascular Diseases
ISSN : 2641-7731
Launched : 2016
Journal of Behavior
ISSN : 2576-0076
Launched : 2016
Annals of Clinical and Experimental Metabolism
ISSN : 2572-2492
Launched : 2016
Clinical Research in Infectious Diseases
ISSN : 2379-0636
Launched : 2013
JSM Microbiology
ISSN : 2333-6455
Launched : 2013
Journal of Family Medicine and Community Health
ISSN : 2379-0547
Launched : 2013
Annals of Pregnancy and Care
ISSN : 2578-336X
Launched : 2017
JSM Cell and Developmental Biology
ISSN : 2379-061X
Launched : 2013
Annals of Aquaculture and Research
ISSN : 2379-0881
Launched : 2014
Clinical Research in Pulmonology
ISSN : 2333-6625
Launched : 2013
Journal of Immunology and Clinical Research
ISSN : 2333-6714
Launched : 2013
Annals of Forensic Research and Analysis
ISSN : 2378-9476
Launched : 2014
JSM Biochemistry and Molecular Biology
ISSN : 2333-7109
Launched : 2013
Annals of Breast Cancer Research
ISSN : 2641-7685
Launched : 2016
Annals of Gerontology and Geriatric Research
ISSN : 2378-9409
Launched : 2014
Journal of Sleep Medicine and Disorders
ISSN : 2379-0822
Launched : 2014
JSM Burns and Trauma
ISSN : 2475-9406
Launched : 2016
Chemical Engineering and Process Techniques
ISSN : 2333-6633
Launched : 2013
Annals of Clinical Cytology and Pathology
ISSN : 2475-9430
Launched : 2014
JSM Allergy and Asthma
ISSN : 2573-1254
Launched : 2016
Journal of Neurological Disorders and Stroke
ISSN : 2334-2307
Launched : 2013
Annals of Sports Medicine and Research
ISSN : 2379-0571
Launched : 2014
JSM Sexual Medicine
ISSN : 2578-3718
Launched : 2016
Annals of Vascular Medicine and Research
ISSN : 2378-9344
Launched : 2014
JSM Biotechnology and Biomedical Engineering
ISSN : 2333-7117
Launched : 2013
Journal of Hematology and Transfusion
ISSN : 2333-6684
Launched : 2013
JSM Environmental Science and Ecology
ISSN : 2333-7141
Launched : 2013
Journal of Cardiology and Clinical Research
ISSN : 2333-6676
Launched : 2013
JSM Nanotechnology and Nanomedicine
ISSN : 2334-1815
Launched : 2013
Journal of Ear, Nose and Throat Disorders
ISSN : 2475-9473
Launched : 2016
JSM Ophthalmology
ISSN : 2333-6447
Launched : 2013
Journal of Pharmacology and Clinical Toxicology
ISSN : 2333-7079
Launched : 2013
Annals of Psychiatry and Mental Health
ISSN : 2374-0124
Launched : 2013
Medical Journal of Obstetrics and Gynecology
ISSN : 2333-6439
Launched : 2013
Annals of Pediatrics and Child Health
ISSN : 2373-9312
Launched : 2013
JSM Clinical Pharmaceutics
ISSN : 2379-9498
Launched : 2014
JSM Foot and Ankle
ISSN : 2475-9112
Launched : 2016
JSM Alzheimer's Disease and Related Dementia
ISSN : 2378-9565
Launched : 2014
Journal of Addiction Medicine and Therapy
ISSN : 2333-665X
Launched : 2013
Journal of Veterinary Medicine and Research
ISSN : 2378-931X
Launched : 2013
Annals of Public Health and Research
ISSN : 2378-9328
Launched : 2014
Annals of Orthopedics and Rheumatology
ISSN : 2373-9290
Launched : 2013
Journal of Clinical Nephrology and Research
ISSN : 2379-0652
Launched : 2014
Annals of Community Medicine and Practice
ISSN : 2475-9465
Launched : 2014
Annals of Biometrics and Biostatistics
ISSN : 2374-0116
Launched : 2013
JSM Clinical Case Reports
ISSN : 2373-9819
Launched : 2013
Journal of Cancer Biology and Research
ISSN : 2373-9436
Launched : 2013
Journal of Surgery and Transplantation Science
ISSN : 2379-0911
Launched : 2013
Journal of Dermatology and Clinical Research
ISSN : 2373-9371
Launched : 2013
JSM Gastroenterology and Hepatology
ISSN : 2373-9487
Launched : 2013
TEST Journal of Dentistry
ISSN : 1234-5678
Launched : 2014
Annals of Nursing and Practice
ISSN : 2379-9501
Launched : 2014
JSM Dentistry
ISSN : 2333-7133
Launched : 2013
Author Information X