Last reviewed · How we verify
Avalide
At a glance
| Generic name | Avalide |
|---|---|
| Sponsor | Roxane Laboratories |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue AVALIDE 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 AVALIDE as soon as p
Common side effects
- Fatigue
- Dizziness
- Musculoskeletal pain
- Nausea
- Headache
- Sinus abnormality
- Cough
- Upper respiratory infection
- Pharyngitis
- Diarrhea
- Rhinitis
- Urinary tract infection
Serious adverse events
- Myocardial infarction
- Angina pectoris
- Syncope
- Cardiorespiratory arrest
- Heart failure
- Hypertensive crisis
- Cerebrovascular accident
- Aplastic anemia
- Pancreatitis
- Agranulocytosis
Key clinical trials
- Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.
- Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions (NA)
- Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions (NA)
- Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients (PHASE3)
- I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy (PHASE4)
- Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension (PHASE3)
- Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension (PHASE3)
- I PREVENT - Irbesartan In Hypertensive Diabetic Patients (PHASE4)
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 |