Hydralazine is an arteriolar vasodilator sold in the U.S. under 2 brand and generic names, for heart failure, malignant hypertension and pulmonary hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Apresoline (application NDA008303). Other hydralazine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE 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.
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 Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary: difficulty in urination Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitivity Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other: nasal congestion, flushing, lacrimation, conjunctivitis.
Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $1 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| I3;1;2 | 20 mg / 37.5 mg | orange | round | — |
| 20;N | 37.5 mg / 20 mg | orange | round | — |
| I3;1;2 | 20 mg / 37.5 mg | orange | round | — |
| 20;N | 37.5 mg / 20 mg | orange | round | — |
| EP;101 | 10 mg | pink | round | — |
| EP;103 | 50 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
SKY PACKAGING · Jan 24, 2025
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
SKY PACKAGING · Jan 24, 2025
Hydralazine HCl Tablets
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Nov 5, 2024
HydrALAZINE Hydrochloride Tablets
an 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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Feb 9, 2024
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Amerisource Health Services LLC · Feb 1, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Drug/Drug Interactions: MAO inhibitors should be used with caution in patients receiving hydrALAZINE. When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.
| View → |
| pink |
| round |
| — |
| HP;2 | 25 mg | pink | round | — |
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| I;4 | 37.5 mg / 20 mg | orange | oval | — |
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| SG;183 | 25 mg | orange | round | — |
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