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GlossaryFDA Adverse Event Reporting System

database tracking drug and biologic safety issues post-marketing

The FDA Adverse Event Reporting System (FAERS) is a database managed by the U.S. Food and Drug Administration that collects information on adverse events and medication errors reported by healthcare professionals, consumers, and manufacturers. This system helps the FDA monitor the safety of drugs and biologics after they are marketed, ensuring that any potential risks are identified and managed appropriately.

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research Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a real-world study based on the FDA adverse event reporting system

30 citations , January 2024 in “Frontiers in Pharmacology”

These migraine prevention drugs can cause side effects like constipation, hair loss, injection site reactions, fatigue, and sometimes unexpected issues like Raynaud's phenomenon and weight gain.

research Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system

April 2026 in “Medicine”

Certain medications, especially nervous system drugs, can cause insomnia, with risks varying by age and gender.

Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System

research Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System

March 2026 in “Pharmaceuticals”

Reporter characteristics affect detection of hair loss from cancer therapy.

research Impact of Reporter Type on Signal Detection of Cancer Therapy–Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System

February 2026 in “Preprints.org”

Reporter characteristics affect detection of hair loss from cancer therapy.

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.

research Drug related lipid metabolism abnormalities: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS)

January 2026 in “Nutrición Hospitalaria”

Many drugs can cause lipid metabolism issues, and labels need better warnings.

research Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases

October 2025 in “Frontiers in Medicine”

Ixekizumab has known and some unexpected side effects.

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.

Multidimensional Assessment of Adverse Events of Finasteride: A Real-World Pharmacovigilance Analysis Based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024

research Multidimensional assessment of adverse events of finasteride：a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024

March 2025 in “PLoS ONE”

Finasteride can cause long-term side effects like sexual dysfunction and depression.

research Multidimensional assessment of adverse events of finasteride:a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024

August 2024 in “medRxiv (Cold Spring Harbor Laboratory)”

Finasteride has various adverse effects, including sexual dysfunction and mental health issues, which vary by age and gender.

research Correction to: An evaluation of the federal adverse events reporting system data on adverse effects of 5‑alpha reductase inhibitors

September 2021 in “World journal of urology”

The correction states that the label change for Finasteride was in 2012, leading to more reports of side effects from non-healthcare people.

research A cross‐sectional analysis of medications used by patients reporting alopecia areata on the FDA adverse events reporting system

6 citations , January 2024 in “International Journal of Dermatology”

Monoclonal antibodies are often linked to alopecia areata cases.

research Association of alopecia areata with COVID-19 vaccination: A vaccine adverse events reporting system analysis

January 2026 in “Dermatology Online Journal”

COVID-19 vaccination may be linked to alopecia areata, especially in young adults.

Cutaneous Adverse Reactions Associated With Enfortumab Vedotin: A Pharmacovigilance Study Based on the FDA Adverse Event Reporting System

research Cutaneous adverse reactions associated with enfortumab vedotin: a pharmacovigilance study based on the FDA adverse event reporting system

April 2026 in “Frontiers in Medicine”

Enfortumab vedotin can cause skin issues, especially in older males, needing early monitoring.

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 Ovary and uterus related adverse events associated with statin use: an analysis of the FDA Adverse Event Reporting System

11 citations , July 2020 in “Scientific Reports”

Statins may be linked to reproductive organ conditions, and their risks should be monitored.

research Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database

2 citations , December 2021 in “Korean Journal of Clinical Pharmacy”

research Evaluating the safety profile of α-1 blockers, 5α-reductase inhibitors, and PDE5I for BPH: a disproportionality analysis of real-world adverse events based on FDA adverse event reporting system (FAERS)

March 2026 in “The Aging Male”

PDE5 inhibitors cause earlier adverse events in BPH treatment, requiring careful monitoring.

Safety Concerns of Paternal Drug Exposure on Fertility, Pregnancy, and Offspring: An Analysis Based on the FDA Adverse Event Reporting System

research Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system

October 2024 in “Andrology”

Paternal drug exposure can harm fertility, pregnancy outcomes, and offspring health, with specific drugs linked to various reproductive issues.

Low-Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System With a Focus on Pericardial Effusions

research Low‐Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System (FAERS) With a Focus on Pericardial Effusions

September 2024 in “Journal of Cosmetic Dermatology”

Low-dose oral minoxidil can cause serious side effects like heart issues, so use the lowest effective dose.

research A disproportionality analysis of adverse events caused by pexidartinib from the FDA adverse event reporting system

2 citations , August 2025 in “Scientific Reports”

Pexidartinib often causes liver issues and fatigue, especially in women.

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 Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017

22 citations , December 2018 in “British Journal of Clinical Pharmacology”

HPV vaccines are generally safe but need further investigation for rare side effects.

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.

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 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.

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.

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.

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 Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database

1 citations , August 2024 in “Expert Opinion on Drug Safety”

Finasteride is most linked to drug-induced erectile dysfunction.