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Glossary Food and Drug Administration

U.S. agency ensuring safety and efficacy of drugs and food

The Food and Drug Administration (FDA) is a U.S. government agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The FDA also plays a crucial role in advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable.

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research (719) Signal Detection of Depression and Suicidality With the 5-Alpha Reductase Inhibitors: Evidence from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Database

June 2026 in “The Journal of Sexual Medicine”

This study found that psychiatric adverse drug reactions were more frequently reported with finasteride than with dutasteride, but it remains unclear if there is a causal relationship.

research US Food and Drug Administration Warning Regarding Finasteride and Suicidal Ideation: What Should Urologists Know?

April 2023 in “European urology open science”

This study reviews the psychological side effects of finasteride, noting a potential association between 5-AR inhibitors and increased depressive symptoms, but emphasizes that the causal link to suicidal ideation remains unclear; the authors recommend mental health screenings and close monitoring for patients starting this medication.

research PD29-07 DRUGS ASSOCIATED THE MOST WITH MALE-FACTOR INFERTILITY: ASSESSMENT OF THE 2010-2020 FOOD AND DRUG ADMINISTRATION (FDA) PHARMACOVIGILANCE DATABASE

August 2021

This study found that testosterone and finasteride were significantly associated with reports of male-factor infertility based on FDA pharmacovigilance data from 2010 to 2020.

research The Chinese State Food and Drug Administration has issued Sinovac Biotech a New Drug Certificate approving its split influenza vaccine

March 2005 in “Inpharma Weekly”

China approved Sinovac's flu vaccine, Japan approved RiUP for female hair loss, and Nippon Kayaku's three cancer drugs.

research Drug-Induced Hair Loss: Analysis of the Food and Drug Administration’s Adverse Events Reporting System Database

July 2024 in “Skin Appendage Disorders”

This study analyzed adverse event reports from the FDA database and found that drugs such as immunomodulatory agents, monoclonal antibodies, minoxidil, contraceptives, and anti-TNF drugs are frequently associated with hair loss, suggesting guidance for dermatologists in identifying common medications linked to alopecia.

research A pharmacovigilance study of drug‐reduced male semen quality based on the Food and Drug Administration adverse event reporting system database

June 2024 in “Andrology”

Using data from the FDA's adverse event reporting system, this study identified 59 drugs linked to reduced male semen quality, with finasteride, dutasteride, and tamsulosin among the most frequently reported.

research Retrospective analysis of smell and taste disturbances associated with dermatologic medications reported to the United States Food and Drug Administration and relevance to COVID-19 infections

5 citations , May 2020 in “Journal of the American Academy of Dermatology”

This article proposes naming the visual identification of androgenic alopecia in COVID-19 patients as the "Gabrin sign" to indicate higher risk for severe symptoms, but reports no new clinical results.

research Novel drugs of United States Food and Drug Administration approved in 2024

March 2026 in “Korean Journal of Clinical Pharmacy”

In this review, researchers discuss 50 novel drugs approved by the FDA in 2024, highlighting key agents like vadadustat for anemia in chronic kidney disease and donanemab for Alzheimer’s, and focusing on their roles in pharmacy education and clinical decision-making.

research Medications Most Commonly Associated With Erectile Dysfunction: Evaluation of the Food and Drug Administration National Pharmacovigilance Database

2 citations , July 2022 in “Sexual Medicine”

This study found that 5-α reductase inhibitors and neuropsychiatric medications were most frequently reported for erectile dysfunction in a national pharmacovigilance database from 2010 to 2020.

research Real-world safety of Tepotinib: Insights from the Food and Drug Administration Adverse Event Reporting System

1 citations , December 2025 in “PLoS ONE”

This study evaluated the real-world safety of Tepotinib for treating NSCLC with METex14 skipping mutations, confirming known adverse events and identifying new signals like deafness and taste disorder, especially highlighting early monitoring.

research A response to “Inconsistent platelet-rich plasma product from the Food and Drug Administration cleared devices: A retrospective review of clinic data”

1 citations , April 2021 in “Journal of the American Academy of Dermatology”

This retrospective review found that platelet-rich plasma products from FDA-cleared devices for alopecia were inconsistent, highlighting a need for more detailed examination of preparation methods.

research Risk assessment of the top 60 drugs for drug-related sexual dysfunction: a disproportion analysis from the Food and Drug Administration adverse event reporting system

August 2025 in “The Journal of Sexual Medicine”

This retrospective pharmacovigilance study identified 34 drugs, including finasteride and dutasteride, that may be associated with sexual dysfunction, with a higher risk observed in males aged 31-45.

research The Role of Patient‐ and Drug‐Related Factors in Oral Minoxidil and Pericardial Effusion: Analyses of Data From the United States Food and Drug Administration Adverse Event Reporting System

December 2024 in “Journal of Cosmetic Dermatology”

This study found that oral minoxidil was more likely to be associated with pericardial effusion compared to other adverse effects, with the relationship appearing dose independent.

research Medications Mostly Associated With Ejaculatory Disorders: Assessment of the Eudra-Vigilance and Food and Drug Administration Pharmacovigilance Databases Entries

February 2024 in “Urology”

This study found that among ten identified medications associated with ejaculatory disorders, Paroxetine and Tamsulosin were mainly linked to delayed and retrograde ejaculation, while Finasteride and Sildenafil were most associated with painful ejaculation and ejaculation failure according to reports from FDA-FAERS and Eudra-Vigilance databases.

research PD49-02 MEDICATIONS MOST COMMONLY ASSOCIATED WITH ERECTILE DYSFUNCTION: EVALUATION OF THE FOOD AND DRUG ADMINISTRATION NATIONAL PHARMACOVIGILANCE DATABASE

April 2022

This study found that 5-alpha reductase inhibitors had the highest association with erectile dysfunction reports among medications analyzed in the FDA's national pharmacovigilance database.

research A Systematic Review and Meta-analysis of Randomized Controlled Trials of United States Food and Drug Administration-Approved, Home-use, Low-Level Light/Laser Therapy Devices for Pattern Hair Loss: Device Design and Technology.

9 citations , November 2021 in “PubMed”

This study found that FDA-approved low-level light/laser therapy devices significantly increased hair density in individuals with pattern hair loss compared to sham devices.

research Are finasteride-related penile curvature/Peyronie’s disease Adverse Event Reports worthy of further clinical investigation? Disproportionality analysis based on both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) pharmacovigilance databases

2 citations , May 2022 in “International Journal of Impotence Research”

This pharmacovigilance study found strong disproportionality signals suggesting an association between finasteride and Peyronie's disease-related clinical features, but the evidence does not confirm a causal link.

research Response to “The Role of Patient‐ and Drug‐Related Factors in Oral Minoxidil and Pericardial Effusion: Analyses of Data From the United States Food and Drug Administration Adverse Event Reporting System”

August 2025 in “Journal of Cosmetic Dermatology”

In this study, Gupta et al. observed that pericardial effusions were dose-independently associated with oral minoxidil use for hypertension but not frequently reported during its use for alopecia, suggesting a potential underreporting issue and the need for standardized risk monitoring in alopecia treatment.

research MP44-04 TRENDS IN 5-ALPHA REDUCTASE INHIBITOR USE BEFORE AND AFTER THE FOOD AND DRUG ADMINISTRATION SAFETY WARNING

April 2019 in “The Journal of urology/The journal of urology”

After the FDA's 2011 warning about a potential prostate cancer risk with 5-alpha reductase inhibitors, this study observed a significant decrease in their prescriptions, notably a 49% drop among men with benign prostatic hyperplasia, while primary care providers reduced prescriptions by 60%.

research Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

July 2025 in “International Journal of Dermatology”

In this study, analysis of FDA adverse event reports revealed that topical finasteride was associated with fewer post-finasteride syndrome-like adverse events than oral finasteride, but many reports lack critical data, suggesting caution in attributing causality.

research Finasteride Use Is Associated with Higher Odds of Obstructive Sleep Apnea: Results from the US Food and Drug Administration Adverse Events Reporting System.

January 2020 in “PubMed”

This study found that finasteride use was significantly associated with the reporting of obstructive sleep apnea and insomnia compared to all other drugs in the FAERS database.

research Finasteride Use Is Associated with Higher Odds of Obstructive Sleep Apnea: Results from the US Food and Drug Administration Adverse Events Reporting System.

January 2020 in “Skinmed”

This study found that finasteride use was significantly associated with reports of obstructive sleep apnea and insomnia compared to other drugs in the FAERS database.

research Assessing dutasteride-associated sexual dysfunction using the U.S. Food and Drug Administration Adverse Event Reporting System

7 citations , December 2017 in “Journal of the European Academy of Dermatology and Venereology”

This study found that dutasteride use is associated with increased reports of sexual dysfunction, based on data from the U.S. Food and Drug Administration Adverse Event Reporting System.

research Oral finasteride use and sexual adverse events: signal detection from disproportionality analyses of data from the United States Food and Drug Administration Adverse Event Reporting System

January 2026 in “Journal of Dermatological Treatment”

The researchers reported that oral finasteride 1 mg was associated with more frequent reports of sexual adverse events than dutasteride 0.5 mg, particularly after 2012, which may be influenced by the nocebo effect.

research 0557 Possible Contributory and Protective Factors in Medication Associated Obstructive Sleep Apnea (OSA): Results from the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS)

April 2020 in “Sleep”

In this study, data from the FAERS database indicated varied associations between certain medications and obstructive sleep apnea, with some biologics associated with a decreased risk of developing the condition.

research Is finasteride intake associated with penile curvature/peyronie’s disease? Assessment of both the food and drug administration (FDA) and the European Medicines Agency (EMA) pharmacovigilance databases

October 2021 in “European urology open science”

research Real-world study of adverse events associated with gepant use in migraine treatment based on the VigiAccess and U.S. Food and Drug Administration’s adverse event reporting system databases

25 citations , July 2024 in “Frontiers in Pharmacology”

Gepant medications for migraines show varied safety profiles in this study, with specific adverse events reported across systems like gastrointestinal and skin disorders, highlighting the need for tailored treatment and monitoring.

research Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration

4 citations , March 2020 in “Cutaneous and ocular toxicology”

In this double-blind, randomized controlled study, researchers found that Wen by Chaz Dean Sweet Almond Mint Cleansing Conditioner was similarly tolerated compared to three other hair cleansing conditioners and was significantly better tolerated than salicylic acid shampoo or baby shampoo in terms of skin reactions.

research The Possible Role of Prescribing Medications, Including Central Nervous System Drugs, in Contributing to Male-Factor Infertility (MFI): Assessment of the Food and Drug Administration (FDA) Pharmacovigilance Database

November 2023 in “Brain Sciences”

This study investigated medications potentially linked to male-factor infertility using the FDA Adverse Event Reporting System and found that finasteride, testosterone, valproate, and other drugs showed significant disproportionate reporting of infertility cases, highlighting a potential under-reporting issue to regulatory bodies.

research Food Administration and Not Genetic Variants Causes Pharmacokinetic Variability of Tadalafil and Finasteride

1 citations , October 2023 in “Journal of personalized medicine”

In this study, researchers investigated genetic variants in pharmacogenes affecting tadalafil and finasteride pharmacokinetics, finding fed volunteers had higher drug exposure than fasting individuals, but genetic variation did not significantly impact pharmacokinetics after correcting for multiple comparisons.