What are the common adverse effects of spironolactone?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: October 2, 2026 • View editorial policy

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.

Ask Question

Common Side Effects of Spironolactone

The most common side effects of spironolactone are menstrual irregularities (occurring in approximately 40% of patients), diuresis (29%), breast tenderness (17%), breast enlargement/gynecomastia, fatigue, headache, and dizziness. 1

Frequent Side Effects (Dose-Related)

The side effects of spironolactone are dose-dependent and generally well-tolerated overall 2:

Hormonal/Reproductive Effects

  • Menstrual irregularities: 22-40.6% of patients, more common at higher doses and less frequent when combined with oral contraceptives 1
  • Breast tenderness: 17% of patients 2
  • Breast enlargement/gynecomastia: Particularly problematic in men (10% vs placebo in clinical trials; led to premature study discontinuation in male acne patients at 200 mg daily) 2, 3
  • Decreased libido and erectile dysfunction 4
  • Postmenopausal bleeding 4

Fluid/Electrolyte Effects

  • Diuresis: 29% of patients 2
  • Hypovolemia and hypotension 4

Neurological Effects

  • Fatigue 2, 1
  • Headache 2, 1
  • Dizziness 2, 1
  • Lethargy, mental confusion, drowsiness, ataxia 4

Gastrointestinal Effects

  • Nausea, vomiting, diarrhea, cramping 4
  • Gastritis, gastric bleeding, ulceration 4

Serious but Less Common Side Effects

Hyperkalemia

Hyperkalemia is rare in young, healthy individuals with normal hepatic, adrenal, and renal function 2. In young healthy women (18-45 years) taking 50-200 mg daily for acne, only 0.75% of potassium measurements exceeded 5.0 mmol/L, with half normalizing on repeat testing 2.

Risk is significantly elevated in:

  • Older patients
  • Patients with hypertension, diabetes mellitus, chronic kidney disease
  • Those taking ACE inhibitors, ARBs, NSAIDs, or digoxin
  • Patients with impaired renal, hepatic, or adrenal function 1

Renal Effects

  • Worsening renal function (including renal failure), particularly in patients with pre-existing kidney disease 4, 5
  • Nonclinically relevant potassium elevations occur in approximately 13.7% of patients 2

Hematologic Effects

  • Leukopenia (including agranulocytosis)
  • Thrombocytopenia 4

Dermatologic Effects

  • Stevens-Johnson Syndrome (SJS)
  • Toxic epidermal necrolysis (TEN)
  • Drug rash with eosinophilia and systemic symptoms (DRESS)
  • Alopecia, pruritus, urticaria, maculopapular or erythematous eruptions 4

Hepatic Effects

  • Mixed cholestatic/hepatocellular toxicity (very rare, with one reported fatality) 4
  • Impaired neurological function, worsening hepatic encephalopathy, and coma in patients with cirrhosis and ascites due to sudden fluid/electrolyte shifts 4

Other Serious Effects

  • Leg cramps 4
  • Anaphylactic reactions, vasculitis 4
  • Fever 4

Important Clinical Considerations

Monitoring Requirements

Potassium monitoring is NOT routinely required in young, healthy patients but should be performed in:

  • Older patients
  • Those with comorbidities (hypertension, diabetes, CKD)
  • Patients on ACE inhibitors, ARBs, NSAIDs, or digoxin
  • Baseline, during therapy, and after dose increases 1, 2

Dietary Counseling

Patients should avoid high-potassium foods including low-sodium processed foods and coconut water 2

Cancer Risk

Despite a black box warning based on animal studies showing tumors at 150 times human doses, large systematic reviews of 4.5 million individuals found no association between spironolactone use and breast, ovarian, bladder, kidney, gastric, or esophageal cancer 1. One study showed decreased prostate cancer risk 1.

Pregnancy Considerations

Spironolactone is contraindicated in pregnancy (pregnancy category C). Animal studies show feminization of male fetuses; human data are limited but include one case of ambiguous genitalia 2, 1, 4. Concurrent oral contraceptive use is often recommended to prevent pregnancy and regulate menses 2.

References

1
Guideline

guidelines of care for the management of acne vulgaris.

Journal of the American Academy of Dermatology, 2024

2
Guideline

guidelines of care for the management of acne vulgaris.

Journal of the American Academy of Dermatology, 2016

Related Questions

What is the recommended plan of care, including dosing, monitoring, and follow‑up, for a patient taking spironolactone?
Should spironolactone be initiated in a patient with heart failure with preserved ejection fraction who has normokalemia and moderate renal impairment?
In a patient with heart failure with preserved ejection fraction and an estimated glomerular filtration rate of 28 mL/min/1.73 m², is spironolactone still appropriate?
How can I manage breast tenderness associated with spironolactone therapy?
Are there any drug interactions between visatril (spironolactone), lithium, and doxepin?
What should be done if a patient accidentally ingests a higher dose of Xywav (calcium, magnesium, potassium, and sodium oxybate) than prescribed?
Should I be concerned about a rise in prostate-specific antigen from 1.1 ng/mL to 1.2 ng/mL over one year?
How can I optimize an inpatient Jehovah's Witness patient scheduled for open‑heart surgery in the next 2–3 days who will not accept blood products?
What emergency evaluation and management is indicated for a patient who sustained a head injury last night, denies loss of consciousness, cannot recall how she braced the fall, and now presents with dizziness, a strange head sensation, and neck and back pain?
Can urine output decrease to only a few drops per minute in the Foley catheter bag a few hours after a transurethral resection of bladder tumor (TURBT)?
How does oxycodone (an opioid agonist) affect dopamine neurotransmission?

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.