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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 How Routine Pharmacovigilance Failed to Identify Finasteride’s Persistent Sexual Side Effects

October 2021 in “International Journal of Andrology”

Finasteride, a hair loss drug, has unaddressed sexual side effects due to the manufacturer's inadequate safety measures and lack of additional studies.

research Supplementary Material for: Finasteride and Suicide: A Postmarketing Case Series

January 2020 in “Figshare”

The study explored a possible link between finasteride use and suicide.

research A Gender Hypothesis of Sex Disparities in Adverse Drug Events

8 citations, November 2023 in “Social Science & Medicine”

Gendered social factors, not just biology, contribute to sex differences in adverse drug events.

research Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study

69 citations, July 2015 in “Pharmacotherapy”

Low-dose finasteride may cause lasting sexual dysfunction and suicidal thoughts in young men.

research Finasteride and Suicide: A Postmarketing Case Series

6 citations, January 2020 in “Dermatology”

Finasteride may increase suicide risk; more research needed.

research Persistent Erectile Dysfunction in Men Exposed to 5α-Reductase Inhibitors, Finasteride, or Dutasteride

50 citations, March 2017 in “PeerJ”

Using finasteride or dutasteride may cause long-lasting erectile dysfunction.

research A Case of Severe Autoimmune Hemolytic Anemia After Receipt of First Dose of SARS-CoV-2 Vaccine

23 citations, July 2021 in “International journal of laboratory hematology”

An 84-year-old man developed severe anemia after his first COVID-19 vaccine shot, improved with treatment, and was advised against a second dose.

research Post-Finasteride Syndrome: Outcomes of FDA Database

May 2016 in “The Journal of Sexual Medicine”

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 Differences in Reproductive Toxicology Between Alopecia Drugs: An Analysis on Adverse Events Among Female and Male Cases

24 citations, October 2016 in “Oncotarget”

Finasteride has a higher risk of reproductive side effects than minoxidil.

research Pharmacovigilance-Based Drug Repurposing: Searching for Putative Drugs With Hypohidrosis or Anhidrosis Adverse Events for Use Against Hyperhidrosis

February 2023 in “European Journal of Medical Research”

Certain existing drugs, like glycopyrronium and botulinum toxin type A, may help treat excessive sweating.

research Investigation of Suicidality and Psychological Adverse Events in Patients Treated With Finasteride

40 citations, November 2020 in “JAMA Dermatology”

Finasteride may cause suicidal thoughts and mental side effects, especially in young people with hair loss.

research Ongoing Concerns Regarding Finasteride for the Treatment of Male-Pattern Androgenetic Alopecia

5 citations, November 2020 in “JAMA Dermatology”

Finasteride may cause side effects; more research needed.

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study

research Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study

5 citations, May 2018 in “Drug Safety”

Using electronic health records can help identify drug side effects but has some limitations.

research Blockbuster Weight-Loss Drugs Not Tied to Suicidality, Studies Show

May 2024 in “Psychiatric News”

Weight-loss drugs are not linked to suicidal thoughts.

research The Post-Finasteride Syndrome: Possible Etiological Mechanisms and Symptoms

3 citations, September 2023 in “International journal of impotence research”

Post-finasteride syndrome causes lasting sexual, mental, and physical issues, needing more research for solutions.

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.

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.

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 in Contributing to Male-Factor Infertility: Assessment of the FDA Pharmacovigilance Database

November 2023 in “Brain Sciences”

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

research Finasteride for Hair Loss: A Review

4 citations, July 2021 in “Journal of Dermatological Treatment”

Finasteride helps hair growth but may cause sexual side effects and depression.

research Topical Ketoconazole: A Systematic Review of Current Dermatological Applications and Future Developments

39 citations, January 2019 in “Journal of Dermatological Treatment”

Ketoconazole cream is effective for skin conditions like seborrheic dermatitis and may help with hair loss and other skin issues, with generally mild side effects.

research Levodopa-Induced Skin Disorders in Patients with Parkinson's Disease: A Systematic Literature Review

12 citations, July 2019 in “Acta Neurologica Belgica”

Levodopa for Parkinson's disease might be linked to skin issues like melanoma, but it's unclear if the drug or the disease causes them.

Suicidal Behaviors (Suicidal Ideation, Suicide Attempt and Completed Suicide) in Patients Treated with Finasteride for Hair Loss: Results from the U.S. FDA Adverse Event Reporting System Database

research Suicidal Behaviors (Suicidal Ideation, Suicide Attempt and Completed Suicide) in Patients Treated with Finasteride for Hair Loss: Results from the U.S. FDA Adverse Event Reporting System Database

August 2018 in “Journal of The American Academy of Dermatology”

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

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.

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.

research Sun Protection Policies and Behaviors Among U.S. Child Care Centers

August 2018 in “Journal of The American Academy of Dermatology”

Finasteride, a hair loss drug, is linked to increased suicidal thoughts, particularly when used for hair loss.

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 Cyclosporine-Induced Alopecia: A Case Report, FDA Adverse Event Reporting System Analysis and Literature Assessment

August 2024 in “Frontiers in Pharmacology”

Cyclosporine may cause hair loss, so patients need monitoring.

research Sun Behaviors and Quality of Life After First Cutaneous Melanoma Diagnosis

August 2018 in “Journal of The American Academy of Dermatology”

Finasteride use for hair loss is linked to an increased risk of suicidal thoughts and a higher risk of suicide.

research Sunscreen: Cosmetic or Medical Therapy?

August 2018 in “Journal of The American Academy of Dermatology”

The conclusion is that finasteride is linked to an increased risk of suicidal thoughts and a higher risk of completed suicide when used for hair loss.