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Low-Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System (FAERS)
Aditya K Gupta1,2, Mary A Bamimore1, Husam Abdel-Qadir3,4
1Mediprobe Research Inc., London, Ontario, Canada.
Background:
Low-dose oral minoxidil (LDOM) is used to treat hair loss, but the literature on its safety profile is relatively sparse.
Aims:
Using the FDA Adverse Event Reporting System (FAERS) database, we determined signals for adverse events (AEs) with LDOM use.
Methods:
Four sets of case/noncase study disproportionality analyses were conducted to determine reporting odds ratio (ROR) for 10 AEs including pericardial effusion (PE). The oral minoxidil dose ranges were: (i) ≤1.25 mg (i.e., 0-1.25 mg), (ii) ≤2.5 mg (i.e., 0-2.5 mg), (iii) ≤5 mg (i.e., 0-5 mg), and (iv) ≤10 mg (i.e., 0-10 mg).
Results:
For ≤1.25 mg, we detected a signal for PE (ROR = 16.41, 95% CI: 2.29, 117.37, p < 0.05). For ≤2.5 mg, the analyses detected a signal for PE (ROR = 13.30, 95% CI: 5.96, 29.68, p < 0.05); the ROR in the absence of cardiac impairment was 5.34 (95% CI: 1.33, 21.37, p < 0.05); in the presence of cardiac impairment, the ROR was 49.42 (95% CI: 18.27, 133.66, p < 0.05). A signal for PE was also detected at ≤5 and ≤10 mg. For PE, there was a significant (p < 0.05) association with a patient outcome of "life threatening" only at the ≤10 mg dose range.
Conclusions:
Our study, the first FAERS-based signal detection study for LDOM, found significant associations between LDOM use and several AEs. In the absence of causal evidence, these correlations warrant more attention regarding safe use of LDOM. Until more safety data are available, we recommend using LDOM at the lowest effective dose (≤5 mg/day).
Insights
Low-dose oral minoxidil (LDOM) use is associated with adverse events, including pericardial effusion. Researchers recommend using LDOM at the lowest effective dose due to sparse safety data.
Area of Science:
- Pharmacovigilance
- Dermatology
- Cardiology
Background:
- Low-dose oral minoxidil (LDOM) is a common treatment for hair loss.
- The safety profile of LDOM is not well-established, with limited literature available.
- Adverse events (AEs) associated with LDOM require further investigation.
Purpose of the Study:
- To identify potential adverse events (AEs) linked to low-dose oral minoxidil (LDOM) usage.
- To analyze safety signals using the FDA Adverse Event Reporting System (FAERS) database.
- To assess the association between LDOM and specific AEs, including pericardial effusion (PE).
Main Methods:
- Disproportionality analyses (case/noncase studies) were performed on FAERS data.
- Reporting odds ratios (ROR) were calculated for 10 AEs, with a focus on pericardial effusion (PE).
- Analyses were conducted across various LDOM dose ranges: ≤1.25 mg, ≤2.5 mg, ≤5 mg, and ≤10 mg.
Main Results:
- A significant signal for pericardial effusion (PE) was detected across all analyzed LDOM dose ranges (≤1.25 mg to ≤10 mg).
- For the ≤2.5 mg dose, PE signals were observed both with and without cardiac impairment, with a higher ROR in patients with cardiac issues.
- A "life-threatening" patient outcome was significantly associated with PE only at the highest dose range (≤10 mg).
Conclusions:
- This study identified significant associations between LDOM use and several AEs, notably pericardial effusion.
- While causality is not established, these findings highlight the need for careful monitoring of LDOM safety.
- The study recommends using the lowest effective LDOM dose (≤5 mg/day) until more comprehensive safety data become available.
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