Note: This document contains side effect information about hydralazine. Some dosage forms listed on this page may not apply to the brand name Apresoline.

Applies to hydralazine: oral tablet. Other dosage forms:

• injection solution

Serious side effects of Apresoline

Along with its needed effects, hydralazine (the active ingredient contained in Apresoline) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydralazine:

More common

• Arm, back, or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• fast, pounding, or irregular heartbeat or pulse
• nausea
• shortness of breath
• sweating

Less common

• Black, tarry stools
• blindness or vision changes
• blisters on the skin
• blurred vision
• burning of the face or mouth
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• chills
• clumsiness or unsteadiness
• confusion
• cough
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever and sore throat
• general feeling of discomfort or illness or weakness
• joint pain
• lower back or side pain
• muscle pain
• numbness, tingling, pain, or weakness in the hands or feet
• painful or difficult urination
• pale skin
• shakiness in the legs, arms, hands, or feet
• skin rash or itching
• swelling of the feet or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• trembling or shaking of the hands or feet
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in hands or feet

Rare

• Dark urine
• light-colored stools
• upper right abdominal or stomach pain
• yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking hydralazine:

Symptoms of overdose

• Feeling of warmth
• headache
• redness of the face, neck, arms, and occasionally, upper chest

Other side effects of Apresoline

Some side effects of hydralazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• loss of appetite
• weight loss

Less common

• Constipation
• difficulty with moving
• dizziness
• feeling anxious or depressed
• muscle cramps, pain, or stiffness
• pain in the joints
• rash, hives, welts, or itching
• stuffy nose
• watery eyes

For Healthcare Professionals

Applies to hydralazine: compounding powder, injectable solution, oral tablet.

General

The most frequently reported side effects were palpitations and tachycardia.^[Ref]

Cardiovascular

Very common (10% or more): Palpitations, tachycardia

Common (1% to 10%): Angina pectoris, flushing, hypotension

Uncommon (0.1% to 1%): Heart failure, vasculitis

Very rare (less than 0.01%): Paradoxical pressor response^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea, gastrointestinal disturbances

Very rare (less than 0.01%): Paralytic ileus

Frequency not reported: Constipation^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness

Very rare (less than 0.01%): Peripheral neuritis, paresthesia, tremor, polyneuritis

Frequency not reported: Tingling, numbness^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, joint swelling, myalgia

Uncommon (0.1% to 1%): Systemic lupus erythematosus-like syndrome

Frequency not reported: Muscle cramp^[Ref]

Metabolic

Common (1% to 10%): Anorexia^[Ref]

Immunologic

Common (1% to 10%): Positive antinuclear factor^[Ref]

Respiratory

Uncommon (0.1% to 1%): Nasal congestion, dyspnea, pleural pain^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, leukopenia, neutropenia, thrombocytopenia

Very rare (less than 0.01%): Hemolytic anemia, leukocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis, eosinophilia

Frequency not reported: Blood dyscrasias, hemoglobin decreased, red cell count decreased^[Ref]

Renal

Uncommon (0.1% to 1%): Serum creatinine increased, glomerulonephritis

Very rare (less than 0.01%): Acute renal failure^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, purpura, urticaria, pruritus^[Ref]

Hepatic

Uncommon (0.1% to 1%): Jaundice, liver enlarged, abnormal liver function, hepatitis^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reaction^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Proteinuria, hematuria, urinary retention

Very rare (less than 0.01%): Retroperitoneal fibrosis

Frequency not reported: Urination difficult^[Ref]

Ocular

Uncommon (0.1% to 1%): Lacrimation increased, conjunctivitis

Very rare (less than 0.01%): Exophthalmos^[Ref]

Other

Uncommon (0.1% to 1%): Edema, fever, weight decreased, malaise

Frequency not reported: Chills^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Agitation, anxiety

Very rare (less than 0.01%): Depression, hallucinations

Frequency not reported: Psychotic reactions, disorientation, anxiety^[Ref]