BiDil
- Generic Name: isosorbide dinitrate and hydralazine hcl
- Brand Name: BiDil
BiDil (Isosorbide Dinitrate and Hydralazine Hcl) side effects drug center
BiDil Side Effects Center
What Is BiDil?
BiDil (isosorbide dinitrate and hydralazine hcl) is a combination of a nitrate and a vasodilator used to treat heart failure.
What Are Side Effects of BiDil?
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.
Tell your doctor if you have unlikely but serious side effects of BiDil including:
- numbness and tingling,
- severe tiredness,
- aching/swollen joints,
- rash on nose and cheeks,
- swollen glands,
- change in the amount of urine,
- bloody or pink urine,
- signs of infection (such as fever, chills, persistent sore throat),
- easy bruising or bleeding,
- fainting, or
- irregular or pounding heartbeat.
Dosage for BiDil
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.
What Drugs, Substances, or Supplements Interact with BiDil?
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.
BiDil During Pregnancy and Breastfeeding
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 breastfeeding.
Additional Information
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.
BiDil Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medicine can cause headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use the medicine. Do not stop taking hydralazine and isosorbide dinitrate. Call your doctor before using any headache pain medication.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- numbness or tingling in your hands or feet;
- joint pain or swelling;
- fever, chest pain, general ill feeling;
- fast heart rate;
- shortness of breath that is worse than usual; or
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.
Some side effects may be more likely in older adults.
Common side effects may include:
- headache; or
- dizziness.
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 BiDil (Isosorbide Dinitrate and Hydralazine Hcl)
BiDil Professional Information
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)
&Copy; BiDil Patient Information is supplied by Cerner Multum, Inc. and BiDil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.