Carospir Side Effects Center

Last updated on RxList: 8/29/2022
Carospir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Carospir?

Carospir (spironolactone) oral suspension is an antagonist of aldosterone indicated for the treatment of NYHA Class III-IV heart failure and reduce d ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure; for use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions; and for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions.

What Are Side Effects of Carospir?

Common side effects of Carospir include:

Carospir may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • sudden vision loss,
  • blurred vision,
  • tunnel vision,
  • eye pain or swelling,
  • seeing halos around lights,
  • fast, irregular, or pounding heartbeats,
  • fluttering in your chest,
  • shortness of breath,
  • sudden dizziness,
  • lightheadedness,
  • fainting,
  • severe headache,
  • confusion,
  • slurred speech,
  • arm or leg weakness,
  • trouble walking,
  • loss of coordination,
  • feeling unsteady,
  • very stiff muscles,
  • high fever,
  • profuse sweating, and
  • tremors

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Carospir

The dose of Carospir depends on the condition being treated.

What Drugs, Substances, or Supplements Interact with Carospir?

Carospir may interact with ACE inhibitors, angiotensin receptor blockers (ARBs), aldosterone blockers, nonsteroidal anti-inflammatory drugs (NSAIDs), heparin and low molecular weight heparin, trimethoprim, lithium, digoxin, cholestyramine, and acetylsalicylic acid. Tell your doctor all medications and supplements you use.

Carospir During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Carospir; it may harm a fetus. Carospir does not pass into breast milk but a metabolite of the drug has been detected in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Carospir (spironolactone) Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
Carospir Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urination;
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; o
  • signs of other electrolyte imbalances--increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common side effects may include:

  • breast swelling or tenderness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Carospir (Spironolactone)

SLIDESHOW

Heart Disease: Symptoms, Signs, and Causes See Slideshow
Carospir Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hyperkalemia [see WARNINGS AND PRECAUTIONS]
  • Hypotension and Worsening Renal Function [see WARNINGS AND PRECAUTIONS]
  • Electrolyte and Metabolic Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Gynecomastia [see WARNINGS AND PRECAUTIONS]
  • Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use In Specific Populations]

The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions werereported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drugexposure.

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Reproductive: Gynecomastia [see WARNINGS AND PRECAUTIONS], decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea,postmenopausal bleeding, breast nad nipple pain.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism: Hyperkalemia, electrolyte disturbances [see WARNINGS AND PRECAUTIONS] , hyponatremia, hypovolemia.

Musculoskeletal: Leg cramps.

Nervous system /psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal:Renal dysfunction (including renal failure).

Skin:Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis,chloasma.

DRUG INTERACTIONS

Drugs And Supplements Increasing Serum Potassium

Concomitant administration of CAROSPIR with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general,discontinue potassium supplementation in heart failure patients who start CAROSPIR [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY] .Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving CAROSPIR.

Examples of drugs that can increase potassium include:

  • ACE inhibitors
  • angiotensin receptor blockers
  • aldosterone blockers
  • non-steroidal anti-inflammatory drugs (NSAIDs)
  • heparin and low molecular weight heparin
  • trimethoprim

Lithium

Like other diuretics, CAROSPIR reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically whenCAROSPIR is coadministered [see CLINICAL PHARMACOLOGY] .

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics.Therefore, when CAROSPIR and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see CLINICAL PHARMACOLOGY] .

Digoxin

Spironolactone and its metabolites increase the apparent exposure to digoxin. In patients taking concomitant digoxin, measure serum digoxin concentrations beforeinitiating spironolactone using an assay that does not interact with spironolactone. Reduce digoxin concentrations by decreasing the dose by approximately 15-30%or by modifying the dosing frequency and continue monitoring [see CLINICAL PHARMACOLOGY] .

Cholestyramine

Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine.

Acetylsalicylic Acid

Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when CAROSPIR and acetylsalicylic acid are used concomitantly, CAROSPIR may needto be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see CLINICAL PHARMACOLOGY] .

CYP2C8 And CYP3A Substrates

Spironolactone is an irreversible inhibitor for CYP2C8 and CYP3A4/5 in vitro [see CLINICAL PHARMACOLOGY] . Therefore, spironolactone may increase theexposure of other coadministered drugs that are metabolized by CYP2C8 and CYP3A4/5. Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone.

Read the entire FDA prescribing information for Carospir (Spironolactone)

© Carospir Patient Information is supplied by Cerner Multum, Inc. and Carospir Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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