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Side effects of spironolactone in clinical studies for acne in women
| Side effect |
RCTsTooltip Randomized controlled trials (n (ITTTooltip Intention-to-treat analysis) = 326) |
Case series (n (ITTTooltip Intention-to-treat analysis) = 663)
|
| Number |
% |
Number |
%
|
| Menstrual irregularities |
38 |
13.4 (of 283) |
216 |
33.4 (of 646)
|
| Breast tenderness |
8 |
2.5 |
30 |
4.5
|
| Breast enlargement |
7 |
2.1 |
13 |
2.0
|
| Dizziness/vertigo/lightheadedness |
11 |
3.4 |
≥19a |
≥2.9
|
| Headache |
5 |
1.5 |
≥10a |
≥1.5
|
| Nausea and/or vomiting |
6 |
1.8 |
24 |
3.6
|
| Weight gainb |
5 |
1.5 |
1 |
0.2
|
| Abdominal pain |
0 |
0 |
≥11a |
≥1.7
|
| Polyuria |
2 |
0.6 |
8 |
1.2
|
| Fatigue/lethargy |
1 |
0.3 |
≥12a |
≥1.8
|
| Footnotes: a = Precise values unavailable due to inadequate reporting. b = Not monitored in most studies. Description: Side effects of spironolactone (25–400 mg/day) with ≥1% incidence in a 2017 hybrid systematic review of clinical studies of spironolactone for acne in women. Side effects with <1% incidence included postural hypotension, depression, diarrhea, muscle pain, increased appetite, drowsiness, rashes/drug eruptions, chloasma-like skin pigmentation, polydipsia, weakness, leg edema, libido changes, and palpitations. [...] Certain side effects, like breast enlargement, reduced premenstrual symptoms, and less oily skin/greasy hair, could be beneficial. Side effects often could not be unambiguously attributed to spironolactone due concomitant use of other medications, particularly birth control pills. Hyperkalemia was rare (14/469; 3.0%) and was "invariably mild and clinically insignificant". Risk of bias was high and quality of evidence was low to very low. Sources: [1]
|
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