September 5, 2015
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BiDil

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BiDil




BiDil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/23/2015

BiDil (isosorbide dinitrate and hydralazine hcl) is a combination of a nitrate and a vasodilator used to treat heart failure. Common side effects of BiDil include headache, dizziness, lightheadedness, weakness, nausea, vomiting, fast heartbeat, swollen ankles, and flushing (redness of the face, neck, and chest) as your body adjusts to the medication.

The starting dose of BiDil is one tablet, 3 times a day. The maximum dose should not to exceed two tablets, 3 times a day. BiDil may interact with medications to treat erectile dysfunction, dihydroergotamine, or other heart medicines, especially those used to treat high blood pressure or irregular heartbeats. Tell your doctor all medications you use. During pregnancy, BiDil should be used only when prescribed. It is unknown if this drug passes into breast milk or if it may harm a nursing infant. Consult your doctor before breast-feeding.

Our BiDil (isosorbide dinitrate and hydralazine hcl) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

BiDil in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking hydralazine and isosorbide dinitrate and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • blurred vision and dry mouth;
  • irregular heartbeat; or
  • blood in your urine or stools;
  • numbness, tingling, pain, or weakness of your arms or legs;
  • fainting.

Other, less serious side effects may be more likely to occur. If you experience any of the following side effects, continue to take isosorbide and talk to your doctor:

  • headache or dizziness;
  • flushing (redness of the face, neck and chest);
  • nausea or vomiting;
  • fast heartbeat;
  • swollen ankles; or
  • weakness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for BiDil (Isosorbide Dinitrate and Hydralazine Hcl)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

BiDil Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, dizziness, lightheadedness, nausea, and flushing may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen). If the headaches continue or become severe, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause nerve problems. Tell your doctor promptly if you experience numbness or tingling. Your doctor may recommend a vitamin B6 supplement (pyridoxine).

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe tiredness, aching/swollen joints, rash on nose and cheeks, swollen glands, change in the amount of urine, bloody/pink urine, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, fainting, fast/irregular/pounding heartbeat.

Seek immediate medical attention if this rare but serious side effect occurs: chest/jaw/left arm pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for BiDil (Isosorbide Dinitrate and Hydralazine Hcl)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

BiDil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

BiDil has been evaluated for safety in 517 heart failure patients in A-HeFT. A total of 317 of these patients received BiDil for at least 6 months, and 220 received BiDil for at least 12 months. In A-HeFT, 21% of the patients discontinued BiDil for adverse reactions compared to 12% who discontinued placebo. Overall, adverse reactions were more common in BiDil -treated than in placebo-treated patients. Table 1 lists adverse reactions reported with an incidence, after rounding, ≥ 2% higher on BiDil than on placebo in A-HeFT, regardless of causality. The most common reasons for discontinuing BiDil in the A-HeFT trial was headache (7%).

Table 1: Adverse Reactions Occurring in the A-HeFT Study in ≥ 2% of Patients Treated with BiDil

  BiDil
(N=517) %
Placebo
(N=527) %
Headache 50 21
Dizziness 32 14
Asthenia 14 11
Nausea 10 6
Hypotension 8 4
Sinusitis 4 2
Ventricular tachycardia 4 2
Paresthesia 4 2
Vomiting 4 2
Amblyopia 3 1

In the V-HeFT I and II clinical studies, a total of 587 patients with heart failure were treated with the combination of isosorbide dinitrate and hydralazine hydrochloride. The type, pattern, frequency and severity of adverse reactions reported in these studies were similar to those reported in A-HeFT, described above and no unusual adverse reactions were reported.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BiDil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Use of BiDil: The following adverse reactions have been identified with use of BiDil.

Cardiac Disorders: Palpitations
Ear and labyrinth disorders:
Tinnitus, vertigo
Eye Disorders:
Eyelid edema, vision blurred
Gastrointestinal Disorders:
Abdominal discomfort, constipation
General Disorders and Administration Site Conditions:
Facial pain, flushing, chest discomfort, chest pain, peripheral edema
Musculoskeletal and Connective Tissue Disorders:
Pain in extremity, myalgia
Nervous Disorders:
Dysgeusia, hypoaesthesia, migraine, syncope
Renal and Urinary Disorders:
Chromaturia, pulmonary renal syndrome
Respiratory, Thoracic and Mediastinal Disorders:
Dyspnea
Reproductive System and Breast Disorders:
Erectile dysfunction
Skin and Subcutaneous Tissue Disorders:
Erythema, hyperhidrosis, pruritus, face swelling

Use of Hydralazine Hydrochloride or Isosorbide Dinitrate: The following reactions have been reported with use of either hydralazine hydrochloride or isosorbide dinitrate.

Blood and Lymphatic System Disorders: Blood dyscrasias, agranulocytosis, purpura, eosinophilia, splenomegaly.
Eye Disorders:
Lacrimation, conjunctivitis.
Gastrointestinal Disorders:
Paralytic ileus.
Hepatobiliary Disorders:
Hepatitis.
Psychiatric Disorders:
Psychotic reactions, disorientation.
Renal and Urinary Disorders:
Difficulty in urination.

Read the entire FDA prescribing information for BiDil (Isosorbide Dinitrate and Hydralazine Hcl)

BiDil - User Reviews

BiDil User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication BiDil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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