Template:Side effects of spironolactone in women in clinical studies for acne

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Side effects of spironolactone in clinical studies for acne in women
Side effect	RCTs (n (ITT) = 326)		Case series (n (ITT) = 663)
Side effect	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	≥19^a	≥2.9
Headache	5	1.5	≥10^a	≥1.5
Nausea and/or vomiting	6	1.8	24	3.6
Weight gain^b	5	1.5	1	0.2
Abdominal pain	0	0	≥11^a	≥1.7
Polyuria	2	0.6	8	1.2
Fatigue/lethargy	1	0.3	≥12^a	≥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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