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GlossaryPharmacovigilance

monitoring and evaluating drug safety to prevent adverse effects

Pharmacovigilance, also known as Drug Safety Monitoring, is the science and activities involved in detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It aims to ensure that medicines are used safely and effectively, by collecting and analyzing data on side effects and other issues reported by healthcare professionals and patients.

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research Disproportional Signal of Sexual Dysfunction Reports Associated with Finasteride Use in Young Men with Androgenetic Alopecia: A Pharmacovigilance Analysis of VigiBase

4 citations, March 2022 in “Journal of The American Academy of Dermatology”

Finasteride use in young men with hair loss is linked to sexual dysfunction.

Suspected Adverse Reactions to Medications and Food Supplements Containing Serenoa Repens: A Worldwide Analysis of Pharmacovigilance and Phytovigilance Spontaneous Reports

research Suspected Adverse Reactions to Medications and Food Supplements Containing Serenoa Repens: A Worldwide Analysis of Pharmacovigilance and Phytovigilance Spontaneous Reports

2 citations, July 2023 in “Phytotherapy Research”

Serenoa repens is mostly safe but has some risks, especially at high doses or when used with other products for over two weeks.

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.

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 Pharmacovigilance Analysis of Reports of Sexual Dysfunction Associated with Finasteride Use: Implications for the Post-Finasteride Syndrome

May 2022 in “The Journal of Sexual Medicine”

Finasteride is linked to sexual dysfunction, especially in younger men using it for hair loss.

research Pharmacovigilance Analysis of Reports of Sexual Dysfunction Associated with Finasteride Use: Implications for the Post-Finasteride Syndrome

April 2022 in “The Journal of Sexual Medicine”

Finasteride is linked to sexual dysfunction, especially in younger users treating hair loss.

Risk of Suicide, Hair Loss, and Aspiration with Glucagon-Like Peptide 1 Receptor Agonists: A Real-World Pharmacovigilance Study from the FAERS Database

research Risk of Suicide, Hair Loss, and Aspiration with Glucagon-Like Peptide 1 Receptor Agonists: A Real-World Pharmacovigilance Study from the FAERS Database

November 2024 in “Circulation”

GLP1-RAs may have higher reports of suicide and hair loss, but no strong evidence links them to these issues.

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.

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.

Immunohistochemical, Pharmacovigilance, and Omics Analyses Reveal the Involvement of ATP-Sensitive K+ Channel Subunits in Cancers: Role in Drug-Disease Interactions

research Immunohistochemical, Pharmacovigilance, and Omics Analyses Reveal the Involvement of ATP-Sensitive K+ Channel Subunits in Cancers: Role in Drug-Disease Interactions

3 citations, April 2023 in “Frontiers in Pharmacology”

ATP-sensitive K+ channel subunits, particularly Sur2A, play a significant role in various cancers.

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.

research Cognitive Dysfunction Following Finasteride Use: A Disproportionality Analysis of the Global Pharmacovigilance Database

December 2023 in “Expert Opinion on Drug Safety”

Finasteride use is linked to increased reports of cognitive problems, especially in younger people with hair loss.

Androgenic Effects on Ventricular Repolarization: A Translational Study from Pharmacovigilance Databases to iPSC-Cardiomyocytes

research Androgenic Effects on Ventricular Repolarization: A Translational Study from Pharmacovigilance Databases to iPSC-Cardiomyocytes

October 2019 in “European heart journal”

Androgen-deprivation therapies increase the risk of certain heart conditions, but testosterone treatment may help.

research Investigation of Sexual Dysfunction Linked to Finasteride Use: A Pharmacovigilance Analysis

August 2021 in “The Journal of Urology”

Finasteride use is strongly linked to sexual dysfunction, especially in young men treating hair loss.

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.

Alopecia Induced by Tumor Necrosis Factor-Alpha Antagonists: Description of 52 Cases and Disproportionality Analysis in a Nationwide Pharmacovigilance Database

research Alopecia Induced by Tumor Necrosis Factor-Alpha Antagonists: Description of 52 Cases and Disproportionality Analysis in a Nationwide Pharmacovigilance Database

26 citations, March 2014 in “Rheumatology”

Some drugs used to treat inflammation may cause hair loss.

Severe Hair Loss Associated with Psychotropic Drugs in Psychiatric Inpatients—Data from an Observational Pharmacovigilance Program in German-Speaking Countries

research Severe Hair Loss Associated with Psychotropic Drugs in Psychiatric Inpatients—Data from an Observational Pharmacovigilance Program in German-Speaking Countries

5 citations, August 2018 in “European Psychiatry”

Some psychiatric drugs can cause severe hair loss, especially valproic acid, and it's more likely in women or those with thyroid issues or past hair loss.

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 Analysis of Adverse Drug Reactions in Pediatric Patients with Epilepsy: An Intensive Pharmacovigilance Study

November 2023 in “Children”

Many pediatric epilepsy patients experience preventable severe adverse drug reactions, especially with certain medications and risk factors.

Clinical Characterization of Men with Long QT Syndrome and Torsades de Pointes Associated with Hypogonadism: A Review and Pharmacovigilance Study

research Clinical Characterization of Men with Long QT Syndrome and Torsades de Pointes Associated with Hypogonadism: A Review and Pharmacovigilance Study

17 citations, August 2019 in “Archives of Cardiovascular Diseases”

Low testosterone in men is a risk factor for a specific heart rhythm issue, and testosterone treatment may help prevent it.

Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

research Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

1 citations, March 2024 in “BioDrugs”

Biologics for severe asthma have known side effects, but some new risks need more study.

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 EudraVigilance 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 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.

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

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

August 2021

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

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.

Medications Affecting the Insulin-Like Growth Factor 1/Growth Hormone Axis, Including Teprotumumab, Somatostatin Analogs, and Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies, Are Associated With Elevated Reporting Odds of Alopecia in Women: A Pharmacovigilance Study

research Medications Affecting the Insulin-Like Growth Factor 1/Growth Hormone Axis, Including Teprotumumab, Somatostatin Analogs, and Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies, Are Associated With Elevated Reporting Odds of Alopecia in Women: A Pharmacovigilance Study

April 2023 in “Journal of The American Academy of Dermatology”

Some drugs linked to growth hormones may increase the chance of hair loss in women.

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 Severe Cutaneous Adverse Reactions to Drugs

273 citations, May 2017 in “The Lancet”

Some drugs can cause rare but potentially deadly skin reactions, and early treatment and avoiding the drug again are key.

research Comparison of the Pharmacoeconomic Profiles of Treatment Regimens for Field Pattern Actinic Keratoses

April 2016 in “Journal of The American Academy of Dermatology”

Some blood pressure medications are linked to a higher risk of skin cancer.

research In Young Patients, The Use Of Finasteride Could Be Associated With Increased Risk Of Anxiety, Depression, And Suicide-Related Adverse Events

November 2021 in “Evidencia”

Young patients using finasteride may have higher risks of anxiety, depression, and suicidal thoughts.