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Hydralazine / isosorbide dinitrate Side Effects

For the Consumer

Applies to hydralazine / isosorbide dinitrate: oral tablet

Along with its needed effects, hydralazine / isosorbide dinitrate 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 while taking hydralazine / isosorbide dinitrate:

More common
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Less common
  • Fainting
  • fast, pounding, or irregular heartbeat or pulse
Incidence not known
  • Abdominal or stomach cramps or pain
  • black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest pain or discomfort
  • dark urine
  • diarrhea
  • difficult or labored breathing
  • fever or chills
  • headache, severe and throbbing
  • joint pain
  • light-colored stools
  • lower back or side pain
  • mood or mental changes
  • muscle aches, cramps, or stiffness
  • pain in the arms or legs
  • painful or difficult urination
  • pale skin
  • shortness of breath
  • sores, ulcers, or white spots on the lips or inside the mouth
  • unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness
  • unusual bruising or bleeding
  • unusual weight gain or loss
  • yellow eyes and skin

Some side effects of hydralazine / isosorbide dinitrate 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:

More common
  • Constipation
  • headache
  • nausea or vomiting
Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cough
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
Incidence not known
  • Change in urine color
  • continuing ringing, buzzing or other unexplained noise in the ears
  • feeling of constant movement of self or surroundings
  • feeling of warmth
  • inability to have or keep an erection
  • pinpoint red or purple spots on the skin
  • redness of the face, neck, arms and occasionally, upper chest
  • sensation of spinning
  • stomach soreness or discomfort

For Healthcare Professionals

Applies to hydralazine / isosorbide dinitrate: oral tablet

General

The most common side effects were headache, dizziness, asthenia, and nausea.[Ref]

Nervous system

Very common (10% or more): Headache (50%), dizziness (32%)
Common (1% to 10%): Paresthesia
Postmarketing reports: Tinnitus, dysgeusia, hypoesthesia, migraine, syncope[Ref]

Other

Very common (10% or more): Asthenia (14%)
Postmarketing reports: Vertigo, facial pain, chest discomfort, chest pain, peripheral edema[Ref]

Gastrointestinal

Very common (10% or more): Nausea (10%)
Common (1% to 10%): Vomiting
Postmarketing reports: Abdominal discomfort, constipation[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, ventricular tachycardia
Postmarketing reports: Palpitations, flushing[Ref]

Ocular

Common (1% to 10%): Amblyopia
Postmarketing reports: Eyelid edema, vision blurred[Ref]

Respiratory

Common (1% to 10%): Sinusitis
Postmarketing reports: Dyspnea[Ref]

Dermatologic

Postmarketing reports: Erythema, hyperhidrosis, pruritus, face swelling[Ref]

Genitourinary

Postmarketing reports: Chromaturia, erectile dysfunction[Ref]

Musculoskeletal

Postmarketing reports: Pain in extremity, myalgia[Ref]

Renal

Postmarketing reports: Pulmonary renal syndrome[Ref]

References

1. "Product Information. BiDil (hydralazine-isosorbide dinitrate)." NitroMed Inc, Lexington, MA.

Some side effects of hydralazine / isosorbide dinitrate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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