Last reviewed · How we verify
Avapro
At a glance
| Generic name | Avapro |
|---|---|
| Sponsor | Roxane Laboratories |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue AVAPRO as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue AVAPRO as soon as pos
Common side effects
- Dizziness
- Fatigue
- Diarrhea
- Orthostatic Dizziness
- Orthostatic Hypotension
- Dyspepsia/Heartburn
- Cough
Serious adverse events
- Hyperkalemia
- Anaphylactic Reaction
- Angioedema
- Intestinal Angioedema
- Hepatitis
- Jaundice
- Thrombocytopenia
- Anemia
- Hypoglycemia
- Urticaria
Key clinical trials
- The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy (NA)
- A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia (PHASE3)
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU. (PHASE3)
- ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC) (PHASE2)
- Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy (NA)
- Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients (PHASE4)
- Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Avapro CI brief — competitive landscape report
- Avapro updates RSS · CI watch RSS
- Roxane Laboratories portfolio CI