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What are the possible side effects of Bidil?
Get emergency medical help if you have signs of an allergic reaction to BiDil: 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 BiDil. 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 BiDil side effects may include:
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.
Side effects of Bidil in details
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%).
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 (Bidil) and Hydralazine (Bidil) 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.
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 (Bidil) Hydrochloride or Isosorbide Dinitrate (Bidil): The following reactions have been reported with use of either Hydralazine (Bidil) hydrochloride or Isosorbide Dinitrate (Bidil).
- 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.
What is the most important information I should know about Bidil?
- BiDil may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use BiDil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using BiDil; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- BiDil may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, fever, low fluid intake, excessive sweating, vomiting, or diarrhea can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of dizziness, light-headedness, or weakness. If fainting occurs, notify your doctor as soon as possible.
- BiDil may cause a vitamin B deficiency. Talk with your doctor for more information.
- Tell your doctor or dentist that you take BiDil before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including blood pressure checks, may be performed while you use BiDil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use BiDil with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using BiDil while you are pregnant. It is not known if BiDil is found in breast milk. If you are or will be breast-feeding while you use BiDil, check with your doctor. Discuss any possible risks to your baby.
BiDil is contraindicated in patients who are allergic to organic nitrates.
Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.
Do not use BiDil in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.
- DailyMed. "ISOSORBIDE DINITRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "ISOSORBIDE DINITRATE: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- DTP/NCI. "hydralazine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Bidil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Bidil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effectsNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology