| Side effect | RCTs (n ( ITT) = 326) | Case series (n ( ITT) = 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] | ||||
Template documentationReferences
- ^ Layton AM, Eady EA, Whitehouse H, Del Rosso JQ, Fedorowicz Z, van Zuuren EJ (April 2017). "Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review". Am J Clin Dermatol. 18 (2): 169–191. doi: 10.1007/s40257-016-0245-x. PMC 5360829. PMID 28155090.
| Side effect | RCTs (n ( ITT) = 326) | Case series (n ( ITT) = 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] | ||||
Template documentationReferences
- ^ Layton AM, Eady EA, Whitehouse H, Del Rosso JQ, Fedorowicz Z, van Zuuren EJ (April 2017). "Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review". Am J Clin Dermatol. 18 (2): 169–191. doi: 10.1007/s40257-016-0245-x. PMC 5360829. PMID 28155090.