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Spironolactone and Hydrochlorothiazide

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

  • Abdominal or stomach cramping, burning, or tenderness
  • Back or leg pains
  • Bleeding gums
  • Blistering, peeling, or loosening of the skin
  • Bloating
  • Bloody or black, tarry stools
  • Bloody or cloudy urine
  • Blue lips and fingernails
  • Blurred vision
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Chest pain
  • Chills
  • Clay-colored stools
  • Clear or bloody discharge from the nipple
  • Cloudy urine
  • Confusion
  • Constipation
  • Cough or hoarseness
  • Coughing that sometimes produces a pink frothy sputum
  • Coughing up blood
  • Dark urine
  • Decrease in urine-concentrating ability
  • Decreased appetite
  • Diarrhea
  • Difficult, fast, or noisy breathing, sometimes with wheezing
  • Difficulty with swallowing
  • Dimpling of the breast skin
  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • Dry mouth
  • Fast or irregular heartbeat
  • Fever with or without chills
  • Flushed, dry skin
  • Fruit-like breath odor
  • General body swelling
  • General feeling of discomfort or illness
  • Greatly decreased frequency of urination or amount of urine
  • Headache
  • Heartburn
  • Hives or welts
  • Increased blood pressure
  • Increased hunger
  • Increased sweating
  • Increased thirst
  • Increased urination
  • Indigestion
  • Inverted nipple
  • Joint pain, stiffness, or swelling
  • Loss of appetite
  • Lower back or side pain
  • Lump in the breast or under the arm
  • Muscle cramps or pain
  • Nausea and vomiting
  • Nosebleeds
  • Numbness, tingling, pain, or weakness in the hands, feet, or lips
  • Painful or difficult urination
  • Pains in the stomach, side, or abdomen, possibly radiating to the back
  • Pale skin
  • Persistent crusting or scaling of the nipple
  • Pinpoint red or purple spots on the skin
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Red, irritated eyes
  • Redness or swelling of the breast
  • Redness, soreness, or itching skin
  • Seizures
  • Severe stomach pain
  • Shakiness and unsteady walk
  • Shortness of breath
  • Skin rash
  • Sore on the skin of the breast that does not heal
  • Sore throat
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Sugar in the urine
  • Swelling in the legs and ankles
  • Swelling of the face, hands, fingers, feet, or lower legs
  • Swollen or painful glands
  • Thickening of bronchial secretions
  • Tightness in the chest
  • Trembling
  • Troubled breathing
  • Unpleasant breath odor
  • Unsteadiness, trembling, or other problems with muscle control or coordination
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Unusual weight loss
  • Vomiting of blood or material that looks like coffee grounds
  • Weakness and heaviness of the legs
  • Weight gain
  • Wheezing
  • Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Difficulty with sleeping
  • Disorientation
  • Drowsiness to profound coma
  • Hallucination
  • Lethargy
  • Lightheadedness
  • Mood or other mental changes
  • Rash with flat lesions or small raised lesions on the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Absent, missed, or irregular menstrual periods
  • Bleeding after menopause
  • Burning feeling in the chest or stomach
  • Discoloration of the skin
  • Feeling of constant movement of self or surroundings
  • Inability to have or keep an erection
  • Increased sensitivity of the skin to sunlight
  • Muscle spasm
  • Restlessness
  • Sensation of spinning
  • Severe sunburn
  • Stomach upset
  • Stopping of menstrual bleeding
  • Swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium; or certain diuretics such as amiloride (Midamor®, Moduretic®), triamterene (Dyazide®, Dyrenium®, Maxzide®), or other products containing spironolactone (Aldactone®).

Stop using this medicine and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

This medicine may increase the amount of potassium in your blood. Check with your doctor right away if you are having abdominal pain; confusion; difficulty breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having medical tests. The results of some tests may be affected by this medicine.

This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

Proper Use

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt) and potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For edema:
      • Adults—At first, 100 milligrams (mg) per day, given in either single or divided doses. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For high blood pressure:
      • Adults—At first, 50 to 100 milligrams (mg) per day, given in either single or divided doses. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of spironolactone and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of spironolactone and hydrochlorothiazide combination in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Dofetilide
  • Eplerenone
  • Triamterene

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetyldigoxin
  • Alacepril
  • Arginine
  • Arsenic Trioxide
  • Benazepril
  • Captopril
  • Cilazapril
  • Delapril
  • Deslanoside
  • Digitalis
  • Digitoxin
  • Digoxin
  • Droperidol
  • Enalaprilat
  • Enalapril Maleate
  • Flecainide
  • Fosinopril
  • Imidapril
  • Ketanserin
  • Levomethadyl
  • Lisinopril
  • Lithium
  • Metildigoxin
  • Moexipril
  • Ouabain
  • Pentopril
  • Perindopril
  • Potassium
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Tacrolimus
  • Temocapril
  • Trandolapril
  • Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Alacepril
  • Alclofenac
  • Apazone
  • Benazepril
  • Benoxaprofen
  • Bepridil
  • Bromfenac
  • Bufexamac
  • Calcium Carbonate
  • Captopril
  • Carbamazepine
  • Carprofen
  • Celecoxib
  • Chlorpropamide
  • Cholestyramine
  • Cilazapril
  • Clometacin
  • Clonixin
  • Cyclophosphamide
  • Delapril
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Digitoxin
  • Dipyrone
  • Droxicam
  • Enalaprilat
  • Enalapril Maleate
  • Etodolac
  • Etofenamate
  • Felbinac
  • Fenbufen
  • Fenoprofen
  • Fentiazac
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ginkgo
  • Glipizide
  • Gossypol
  • Ibuprofen
  • Imidapril
  • Indomethacin
  • Indoprofen
  • Isoxicam
  • Ketoprofen
  • Ketorolac
  • Licorice
  • Lisinopril
  • Lornoxicam
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Moexipril
  • Nabumetone
  • Naproxen
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Propyphenazone
  • Proquazone
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Spirapril
  • Sulindac
  • Suprofen
  • Temocapril
  • Tenidap
  • Tenoxicam
  • Tiaprofenic Acid
  • Ticrynafen
  • Tolmetin
  • Topiramate
  • Trandolapril
  • Zofenopril
  • Zomepirac

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anuria (not able to pass urine) or
  • Hyperkalemia (high potassium in the blood) or
  • Kidney disease, severe or
  • Liver disease, severe or
  • Sulfonamide allergy (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®)—Should not be used in patients with these conditions.
  • Asthma, history of—This medicine may cause allergic reactions in patients with this condition.
  • Diabetes or
  • Electrolyte imbalances (e.g., low chloride, magnesium, potassium, or sodium in the body) or
  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
  • Gout or
  • Hypercalcemia (high calcium in the blood) or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Description

Spironolactone and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). It may also be used to treat water retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.

Spironolactone helps prevent your body from absorbing too much salt and keeps your potassium levels from getting too low. It can be used to prevent or treat hypokalemia (low potassium levels in the blood).

Spironolactone and hydrochlorothiazide are both diuretic medicines (“water pills”). They reduce the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor’s prescription.