Spironolactone | Oral Tablets
Important Safety Information: Spironolactone | Oral Tablets
What is this?
This Important Safety Information summarizes key warnings and precautions for spironolactone tablets, an oral prescription medication classified as an aldosterone antagonist and potassium-sparing diuretic. Spironolactone is FDA approved for the treatment of certain types of heart failure, hypertension as add on therapy, edema associated with liver cirrhosis or nephrotic syndrome, and primary hyperaldosteronism . This summary does not include all available information. Always read the full prescribing information and follow your provider’s instructions.
Most Serious Warnings
Spironolactone can cause:
Hyperkalemia, which may be severe and life threatening
Worsening kidney function or renal failure
Symptomatic hypotension
Severe allergic reactions
Endocrine related effects including gynecomastia
Hyperkalemia risk is increased in patients with impaired kidney function or when used with medications or supplements that raise potassium levels .
Who Should NOT Take Spironolactone
Do not take this medication if you:
Have hyperkalemia
Have Addison’s disease
Are taking eplerenone
These are listed contraindications in the FDA approved labeling .
Before Taking Spironolactone, Tell Your Healthcare Provider if You:
Have kidney disease or reduced renal function
Have liver disease or cirrhosis
Have diabetes
Are pregnant or planning pregnancy
Are breastfeeding
Take ACE inhibitors, ARBs, NSAIDs, potassium supplements, potassium containing salt substitutes, lithium, digoxin, or other medications
Spironolactone may affect male fetal development based on animal data. Avoid use in pregnancy unless specifically directed by your provider .
Possible Side Effects
Common or Clinically Significant:
Gynecomastia
Dizziness
Electrolyte abnormalities
Elevated potassium levels
Changes in menstrual cycle
Decreased libido or erectile difficulty
Serious (seek medical attention immediately):
Signs of high potassium such as muscle weakness, irregular heartbeat, or palpitations
Severe dehydration, fainting, or low blood pressure
Rash, swelling of the face or throat, difficulty breathing
Severe skin reactions including blistering or peeling
Signs of liver problems
Adverse reactions including hyperkalemia, renal dysfunction, hypotension, electrolyte abnormalities, and gynecomastia are described in FDA labeling .
While Taking Spironolactone
Avoid potassium supplements and salt substitutes containing potassium
Have your potassium and kidney function monitored regularly
Take consistently with regard to meals
Contact your provider if you experience weakness, confusion, severe dizziness, swelling, or reduced urine output
Pregnancy and Breastfeeding
Spironolactone may affect sex differentiation of a male fetus based on animal data. Avoid use in pregnancy unless the potential benefit outweighs risk . Limited data suggest small amounts of metabolite may be present in breast milk. Discuss risks and benefits with your provider .
Overdose
Symptoms may include drowsiness, confusion, rash, nausea, vomiting, dizziness, diarrhea, or electrolyte disturbances including hyperkalemia . Seek emergency medical care or contact Poison Control immediately if overdose is suspected.
Missed Dose
If you miss a dose, take it as soon as you remember unless it is close to your next scheduled dose. Do not double doses. Follow your provider’s instructions.
Storage
Store at controlled room temperature 20° to 25°C (68° to 77°F) . Keep in a tight, light resistant container and out of reach of children.
Disclaimer
This summary does not include all information about spironolactone and does not replace medical advice. Always consult your healthcare provider or pharmacist for complete prescribing information, drug interactions, and individualized recommendations. You are encouraged to report negative side effects of prescription drugs to the FDA at MedWatch or call 1-800-FDA-1088.
