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GlossaryFood 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”

Finasteride may be linked to more psychiatric issues than dutasteride, but a definite cause isn't proven.

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

April 2023 in “European urology open science”

Urologists should screen for mental health issues before and during finasteride treatment.

Drugs Associated the Most with Male-Factor Infertility: Assessment of the 2010-2020 Food and Drug Administration Pharmacovigilance Database

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

Finasteride and testosterone are the drugs most linked to male infertility, but many other potential drugs may be under-reported.

The Chinese State Food and Drug Administration Has Issued Sinovac Biotech a New Drug Certificate Approving Its Split Influenza Vaccine

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”

Certain medications, including some immune drugs, contraceptives, and hair loss treatments, are often linked to hair loss.

A Pharmacovigilance Study of Drug-Reduced Male Semen Quality Based on the Food and Drug Administration Adverse Event Reporting System Database

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”

Some drugs can reduce male semen quality.

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”

AGA might indicate higher risk for severe COVID-19.

Novel Drugs Approved by the United States FDA in 2024

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

March 2026 in “Korean Journal of Clinical Pharmacy”

In 2024, the FDA approved 50 new drugs, including treatments for hair loss, anemia, high blood pressure, and Alzheimer's.

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”

Certain medications, especially 5-α reductase inhibitors and neuropsychiatric drugs, are often linked to erectile dysfunction.

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”

Inconsistent platelet counts in PRP are due to varying blood volumes, preparation methods, and analyzer types.

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”

Finasteride, dutasteride, and silodosin have the highest risk for causing sexual dysfunction.

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

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”

Oral minoxidil rarely causes pericardial effusion, especially at low doses.

Medications Mostly Associated With Ejaculatory Disorders: Assessment of the EudraVigilance and Food and Drug Administration Pharmacovigilance Databases Entries

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

February 2024 in “Urology”

Certain medications, especially Paroxetine, Tamsulosin, and Finasteride, are linked to ejaculatory disorders.

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

April 2022

Certain medications, especially 5-alpha reductase inhibitors, are commonly linked to erectile dysfunction.

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”

FDA-approved low-level light/laser therapy devices can significantly increase hair density in people with pattern hair loss.

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”

Finasteride may be linked to Peyronie’s disease, but more research is needed.

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

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”

Oral minoxidil users, especially for hypertension, may risk heart issues, and better monitoring guidelines are needed for alopecia patients.

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”

Prescriptions for 5-alpha reductase inhibitors dropped significantly after the FDA's safety warning, especially for men with benign prostatic hyperplasia.

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

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”

Topical finasteride may be safer than oral finasteride, but more research is needed.

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”

Finasteride use is linked to a higher risk of obstructive sleep apnea.

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”

Finasteride use is linked to a higher risk of obstructive sleep apnea.

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”

Dutasteride is linked to a higher chance of sexual dysfunction, especially in younger males and the elderly.

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”

Oral finasteride may cause more sexual side effects than expected, possibly due to negative publicity and reporting bias.

Possible Contributory and Protective Factors in Medication Associated Obstructive Sleep Apnea: Results from the US Food and Drug Administration Adverse Events Reporting System

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”

Some drugs may increase the risk of obstructive sleep apnea, while others like certain biologics might decrease it.

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”

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

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”

Rimegepant causes more nausea and skin issues, while ubrogepant causes more muscle issues; personalized treatment is important.

Tolerability of Hair Cleansing Conditioners: A Double-Blind Randomized Controlled Trial Evaluating Consumer Complaints to the U.S. Food and Drug Administration

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”

Wen by Chaz Dean Sweet Almond Mint Cleansing Conditioner is better tolerated than salicylic acid and baby shampoos.

The Possible Role of Prescribing Medications in Contributing to Male-Factor Infertility: Assessment of the FDA Pharmacovigilance Database

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”

Some medications might contribute to male infertility, with finasteride showing a high number of reports.

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

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

Food intake, not genetics, affects how the body processes tadalafil and finasteride.

Neonatal Finasteride Administration Decreases Dopamine Release in Nucleus Accumbens After Alcohol and Food Presentation in Adult Male Rats

research Neonatal finasteride administration decreases dopamine release in nucleus accumbens after alcohol and food presentation in adult male rats

3 citations , May 2016 in “Behavioural Brain Research”

Finasteride given to baby rats reduces dopamine release and increases alcohol consumption in adult males.