What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
Who it is for
Essential hypertension, alone or as an adjunct.
How to take it and how often
Initiate therapy in gradually increasing dosages; adjust according to individual response
Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week
For the second and subsequent weeks, increase dosage to 50 mg four times daily
For maintenance, adjust dosage to the lowest effective levels
The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE hydrochloride tablets
In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets daily may be required for a significant antihypertensive effect
In such cases, a lower dosage of hydrALAZINE hydrochloride tablets combined with a thiazide and/or reserpine or a beta blocker may be considered
However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug
In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)
Possible side effects
Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent: Digestive: constipation, paralytic ileus. Cardiovascular: hypotension, paradoxical pressor response, edema. Respiratory: dyspnea. …
If you take too much
Acute Toxicity: No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally. Oral LD 50 in rats: 173 and 187 mg/kg. Signs and Symptoms Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. Treatment There is no specific antidote. The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. …
If you miss a dose
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-07-01.
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dU.S. FDA Class II
24 Jan 2025 · SKY PACKAGING · OngoingFailed Impurities/Degradation Specifications
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson CoU.S. FDA Class II
24 Jan 2025 · SKY PACKAGING · OngoingFailed Impurities/Degradation Specifications
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, DistriU.S. FDA Class II
9 Feb 2024 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Terminatedan out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 6808U.S. FDA Class III
1 Feb 2024 · Amerisource Health Services LLC · TerminatedFailed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
A recall usually affects certain batches only. Compare the lot number on your pack.
Check your pack of Hydralazine
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts
Questions about Hydralazine
What is Hydralazine used for?
Essential hypertension, alone or as an adjunct. (From the official U.S. FDA label.)
How do I take Hydralazine?
Follow your prescription or the leaflet in your pack. The official label says: Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence o…
Do I need a prescription for Hydralazine?
Usually yes. Hydralazine is a prescription medicine in most countries. Rules differ by country.
What brands contain Hydralazine?
Hydralazine is sold under names such as Bidil, Hydralazine Hydrochloride. Brand names differ between countries.
How can I check that my Hydralazine is genuine?
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.