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Adverse Drug Reactions
| Body System |
Effect |
Clinical Comment |
| Cardiovascular |
Palpitations, tachycardia, flushing, sodium and water retention, hypotension, paradoxical hypertension, heart failure, angina |
Often administered with a beta-blocker to counteract reflex tachycardia and a diuretic to counteract sodium and water retention. |
| Central Nervous System |
Headache, dizziness, anxiety, disorientation, agitation, depression, hallucinations, sleep disturbances, cerebral ischemia or hypoperfusion |
Mild CNS effects usually do not require medical attention and resolve over time. |
| Dermatologic |
Rash, urticaria, pruritus |
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| Gastrointestinal |
Anorexia, diarrhea, constipation, nausea, vomiting, gastrointestinal distress, paralytic ileus |
Gastrointestinal effects usually do not require medical attention and resolve over time. |
| Genitourinary |
Proteinuria, hematuria, uremia, glomerulonephritis, acute renal failure, urinary retention, difficult micturition, increased serum creatinine concentration |
Microhematuria and/or proteinuria in the presence of elevated ANA titres may result from immune-complex glomerulonephritis and be associated with SLE-like syndrome. |
| Hematologic |
Anemia, leukopenia (agranulocytosis and thrombocytopenia), Coomb’s-test positive hemolytic anemia, leukocytosis, lymphadenopathy, pancytopenia, splenomegaly, antinuclear antibodies |
A positive ANA does not correlate with the onset of the SLE-like syndrome; serial measurement of ANA titre is not recommended. |
| Hepatic |
Jaundice, liver enlargement, elevated liver enzyme, hepatocellular necrosis and granulomatous hepatitis |
Monitor transaminase levels. |
| Hypersensitivity |
SLE-like syndrome, chills, eosinophilia, cutaneous and systemic vasculitis, pruritus, urticaria, hepatitis, fever, vascular collapse |
Clinical manifestations of the syndrome are usually reversible upon stopping hydralazine. |
| Neuromuscular |
Peripheral neuritis with paresthesia, numbness and tingling, polyneuritis, tremor, muscle cramps, weakness |
Peripheral neuritis may respond to pyridoxine administration. |
| Ocular |
Lacrimation, conjunctivitis, blurred vision |
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| Respiratory |
Nasal congestion, dyspnea, pleural pain, pulmonary hemorrhage, pulmonary edema, pulmonary hypertension |
Nasal congestion usually resolves with time. Pleuropulmonary symptoms occur in 30% of patients with SLE-like syndrome. |
| Other |
Weight decrease, malaise, impotence, decreased libido, sweating |
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Drug-Drug Interactions
| Interacting Drug |
Effect |
Clinical Comment |
| β-blockers (e.g., propranolol, metoprolol, oxprenolol) |
Serum levels of extensively metabolized β-blockers may be increased by hydralazine |
The bioavailability of propranolol, metoprolol and oxprenolol are increased by hydralazine, likely because of reduced hepatic blood flow. Adverse events have not been reported. Monitor for increased effects of beta-blocker. |
| Digoxin |
Increased renal clearance and decreased serum levels of digoxin. |
Renal clearance of digoxin increased and serum levels decreased in patients with congestive heart failure who received intravenous hydralazine. It is not known if the effect is sustained during long term administration or whether dosage adjustments of digoxin are required. Monitor digoxin levels in patients receiving intravenous hydralazine. |
| NSAIDs (e.g., indomethacin, diclofenac) |
Decreased hypotensive effect |
NSAIDs can cause sodium and water retention, which opposes the effects of antihypertensive agents such as hydralazine. Blood pressure should be closely monitored in patients receiving the combination of hydralazine plus an NSAID. |
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