Drug
Hydralazine Hydrochloride
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Hepatic Steatosis | 96 | 41.6 | 43.1 | signal |
| 2 | Vasculitis | 58 | 40.1 | 41.0 | signal |
| 3 | Contraindicated Product Administered | 81 | 21.6 | 22.3 | signal |
| 4 | Gout | 40 | 17.9 | 18.2 | signal |
| 5 | Therapeutic Product Effect Decreased | 94 | 17.0 | 17.6 | signal |
| 6 | End Stage Renal Disease | 37 | 16.1 | 16.4 | signal |
| 7 | Haematuria | 61 | 14.3 | 14.6 | signal |
| 8 | Cardiac Failure Congestive | 131 | 13.0 | 13.6 | signal |
| 9 | Systemic Lupus Erythematosus | 52 | 11.8 | 12.0 | signal |
| 10 | Pericardial Effusion | 32 | 11.2 | 11.3 | signal |
| 11 | Hyperkalaemia | 48 | 11.0 | 11.2 | signal |
| 12 | Liver Disorder | 60 | 10.9 | 11.1 | signal |
| 13 | Dialysis | 19 | 10.7 | 10.8 | signal |
| 14 | Gastric Disorder | 46 | 10.6 | 10.8 | signal |
| 15 | Blood Potassium Increased | 19 | 9.4 | 9.5 | signal |
| 16 | Hypertensive Crisis | 13 | 9.3 | 9.4 | signal |
| 17 | Premature Delivery | 18 | 9.0 | 9.1 | signal |
| 18 | Exposure During Pregnancy | 69 | 8.9 | 9.1 | signal |
| 19 | Renal Impairment | 90 | 8.6 | 8.9 | signal |
| 20 | Cardiac Failure | 86 | 8.6 | 8.9 | signal |
| 21 | Tubulointerstitial Nephritis | 17 | 7.3 | 7.3 | signal |
| 22 | Acute Kidney Injury | 138 | 7.3 | 7.6 | signal |
| 23 | Premature Baby | 27 | 7.2 | 7.2 | signal |
| 24 | Hypertension | 187 | 7.1 | 7.5 | signal |
| 25 | Hyperbilirubinaemia | 9 | 7.0 | 7.0 | signal |
| 26 | Hepatic Enzyme Increased | 59 | 7.0 | 7.1 | signal |
| 27 | Blood Pressure Abnormal | 17 | 6.9 | 6.9 | signal |
| 28 | Abdominal Discomfort | 136 | 6.5 | 6.8 | signal |
| 29 | Hepatomegaly | 8 | 6.5 | 6.5 | signal |
| 30 | Drug Intolerance | 75 | 6.3 | 6.4 | signal |
| 31 | Drug-induced Liver Injury | 24 | 6.2 | 6.3 | signal |
| 32 | Ascites | 22 | 6.0 | 6.0 | signal |
| 33 | Proteinuria | 14 | 6.0 | 6.0 | signal |
| 34 | Cardiomegaly | 9 | 5.8 | 5.8 | signal |
| 35 | Skin Reaction | 10 | 5.7 | 5.7 | signal |
| 36 | Caesarean Section | 8 | 5.5 | 5.5 | signal |
| 37 | Gastrointestinal Disorder | 60 | 5.4 | 5.6 | signal |
| 38 | Photosensitivity Reaction | 11 | 5.4 | 5.4 | signal |
| 39 | Nephropathy | 6 | 5.1 | 5.1 | signal |
| 40 | Autoimmune Disorder | 6 | 5.0 | 5.0 | signal |
| 41 | Chronic Kidney Disease | 48 | 5.0 | 5.1 | signal |
| 42 | Renal Tubular Necrosis | 6 | 4.9 | 4.9 | signal |
| 43 | Maternal Exposure During Pregnancy | 53 | 4.8 | 4.9 | signal |
| 44 | Acute Hepatic Failure | 8 | 4.7 | 4.7 | signal |
| 45 | Ventricular Extrasystoles | 6 | 4.6 | 4.6 | signal |
| 46 | Drug Hypersensitivity | 112 | 4.6 | 4.8 | signal |
| 47 | Respiratory Failure | 42 | 4.6 | 4.7 | signal |
| 48 | Abdominal Pain Upper | 111 | 4.3 | 4.5 | signal |
| 49 | Sputum Discoloured | 5 | 4.2 | 4.3 | signal |
| 50 | Eye Haemorrhage | 7 | 4.2 | 4.2 | signal |
| 51 | Product Taste Abnormal | 7 | 4.2 | 4.2 | signal |
| 52 | Sinus Congestion | 7 | 4.2 | 4.2 | signal |
| 53 | Cough | 141 | 4.0 | 4.2 | signal |
| 54 | Injection Site Discomfort | 5 | 3.9 | 3.9 | signal |
| 55 | Frequent Bowel Movements | 13 | 3.9 | 3.9 | signal |
| 56 | Scratch | 5 | 3.9 | 3.9 | signal |
| 57 | Peritonitis | 10 | 3.9 | 3.9 | signal |
| 58 | Transfusion | 5 | 3.8 | 3.8 | signal |
| 59 | Blood Pressure Fluctuation | 11 | 3.7 | 3.7 | signal |
| 60 | Intervertebral Disc Protrusion | 10 | 3.7 | 3.7 | signal |
| 61 | Diabetes Mellitus Inadequate Control | 8 | 3.6 | 3.6 | signal |
| 62 | Nephropathy Toxic | 5 | 3.6 | 3.6 | signal |
| 63 | Diverticulitis | 12 | 3.5 | 3.5 | signal |
| 64 | Bradycardia | 23 | 3.5 | 3.5 | signal |
| 65 | Poisoning Deliberate | 4 | 3.4 | 3.5 | signal |
| 66 | Hospitalisation | 63 | 3.3 | 3.4 | signal |
| 67 | Haemorrhage Intracranial | 6 | 3.2 | 3.2 | signal |
| 68 | Toxic Epidermal Necrolysis | 6 | 3.2 | 3.2 | signal |
| 69 | Renal Injury | 11 | 2.9 | 2.9 | signal |
| 70 | Intentional Dose Omission | 10 | 2.9 | 2.9 | signal |
| 71 | Fluid Overload | 5 | 2.7 | 2.7 | no signal |
| 72 | Spinal Operation | 4 | 2.7 | 2.7 | no signal |
| 73 | Angioedema | 14 | 2.5 | 2.6 | signal |
| 74 | Hallucination, Auditory | 5 | 2.5 | 2.5 | no signal |
| 75 | Decreased Immune Responsiveness | 3 | 2.5 | 2.5 | no signal |
| 76 | Pneumocystis Jirovecii Pneumonia | 3 | 2.4 | 2.4 | no signal |
| 77 | Inappropriate Schedule Of Drug Administration | 20 | 2.2 | 2.2 | signal |
| 78 | Foetal Exposure During Pregnancy | 22 | 2.2 | 2.2 | signal |
| 79 | Product Availability Issue | 6 | 2.1 | 2.1 | no signal |
| 80 | Rebound Effect | 3 | 2.1 | 2.1 | no signal |
| 81 | Product Physical Issue | 5 | 2.0 | 2.0 | no signal |
| 82 | Colitis Ulcerative | 11 | 2.0 | 2.0 | no signal |
| 83 | Respiratory Depression | 3 | 2.0 | 2.0 | no signal |
| 84 | Drug Dose Omission | 38 | 1.8 | 1.8 | no signal |
| 85 | Drug Dispensing Error | 3 | 1.6 | 1.6 | no signal |
| 86 | Completed Suicide | 15 | 1.4 | 1.4 | no signal |
| 87 | Injection Site Bruising | 12 | 1.2 | 1.2 | no signal |
| 88 | Intentional Overdose | 9 | 1.1 | 1.1 | no signal |
| 89 | Drug Exposure During Pregnancy | 3 | 0.7 | 0.7 | no signal |
| 90 | Renal Cancer | 3 | 0.5 | 0.5 | no signal |
| 91 | Device Difficult To Use | 3 | 0.4 | 0.4 | no signal |
| 92 | Drug Dose Omission By Device | 3 | 0.3 | 0.3 | no signal |