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BiDil

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BiDil

BiDil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

BiDil (isosorbide dinitrate and hydralazine hcl) is used to treat heart failure. Isosorbide dinitrate is a nitrate, and hydralazine is a vasodilator. Common side effects include headache, dizziness, lightheadedness, nausea, and flushing 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

BiDil (isosorbide dinitrate and hydralazine hcl)

BiDil (isosorbide dinitrate and hydralazine hcl) has been evaluated for safety in 517 heart failure patients in A-HeFT. A total of 317 of these patients received BiDil (isosorbide dinitrate and hydralazine hcl) for at least 6 months,and 220 received BiDil (isosorbide dinitrate and hydralazine hcl) for at least 12 months. In A-HeFT, 21% of the patients discontinued BiDil (isosorbide dinitrate and hydralazine hcl) for adverse experiences compared to 12% who discontinued placebo.Overall, adverse events were more common in BiDil (isosorbide dinitrate and hydralazine hcl) -treated than in placebo-treated patients. Table 2 lists adverse events reported with an incidence of ≥ 2% in patients treated with BiDil (isosorbide dinitrate and hydralazine hcl) in A-HeFT,and,after rounding to the nearest 1%, occurring more frequently than in the placebo group,regardless of causality. Headache and dizziness were the two most frequent adverse events and were more than twice as frequent in the BiDil (isosorbide dinitrate and hydralazine hcl) group. The most common reasons for discontinuing BiDil (isosorbide dinitrate and hydralazine hcl) in the A-HeFT trial were headache (7%) and dizziness (4%).

Table 2. Adverse Events Occurring in the A-HeFT Study in ≥ 2% of Patients Treated with BiDil (isosorbide dinitrate and hydralazine hcl) .

  BiDil (isosorbide dinitrate and hydralazine hcl)
(N=517)
(% of patients)
Placebo
(N=527)
(% of patients)
Headache 50 21
Dizziness 32 14
Chest pain 16 15
Asthenia 14 11
Nausea 10 6
Bronchitis 8 7
Hypotension 8 4
Sinusitis 4 2
Ventricular tachycardia 4 2
Palpitations 4 3
Hyperglycemia 4 3
Rhinitis 4 3
Paresthesia 4 2
Vomiting 4 2
Amblyopia 3 1
Hyperlipidemia 3 2
Tachycardia 2 1

The following adverse events were reported in A-HeFT in at least 1% but less than 2% of patients treated with BiDil (isosorbide dinitrate and hydralazine hcl) , and also occurred in at least 0.5% more patients than in placebo-treated patients; all such events are included unless they are too non-specific to be meaningful or appear to reflect underlying disease.

Body as a Whole: Allergic reaction,malaise.

Central nervous system: Somnolence.

Gastrointestinal: Cholecystitis.

Metabolic: Hypercholesteremia.

Musculoskeletal: Arthralgia,myalgia, tendon disorder.

Skin:Alopecia,angioedema,sweating.

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

Prior experience with BiDil (isosorbide dinitrate and hydralazine hcl) components

The following additional adverse events have been reported with hydralazine hydrochloride or isosorbide dinitrate but not necessarily with BiDil (isosorbide dinitrate and hydralazine hcl) :

Digestive: paralytic ileus.

Cardiovascular: paradoxical pressor response, crescendo angina.

Neurologic: peripheral neuritis, numbness,tingling, muscle cramps, psychotic reactions,disorientation.

Genitourinary: difficulty in urination.

Hematologic: blood dyscrasias,agranulocytosis,purpura,splenomegaly.

Hypersensitive Reactions: eosinophilia,hepatitis.

Other: nasal congestion,flushing,lacrimation,conjunctivitis.

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

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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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