pharmacopeia
GET
/api/v1/drug/angiotensin-ii

Mechanism of action

Sourced from openFDA

Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein coupled-angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca 2+ /calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.

Indications

Sourced from openFDA
  • Angiotensin II Injection increases blood pressure in adults with septic or other distributive shock. Angiotensin II Injection is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

Dilute Angiotensin II Injection in 0.9% sodium chloride prior to use. See Full Prescribing Information for instructions on preparation and administration of injection. Diluted solution may be stored at room temperature or under refrigeration and should be discarded after 24 hours. Angiotensin II Injection must be administered as an intravenous infusion. ( 2.1 ) • Start Angiotensin II Injection intravenously at 20 nanograms (ng)/kg/min. Titrate as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min. Maintenance dose should not exceed 40 ng/kg/min. ( 2.2 ) 2.1. Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Angiotensin II Injection must be administered as an intravenous infusion. Angiotensin II Injection must be diluted in 0.9% sodium chloride prior to use. Dilute the contents of one vial of Angiotensin II Injection in 0.9% saline to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL. Discard vial and any unused portion of the drug product after use. Table 1: Preparation of Diluted Solution F l u i d Restricted? V i al Strength Withdraw Amount (m L ) I n f usion Bag Size (mL) Final Concentration (ng/mL) No 2.5 mg/mL 1 500 5,000 Yes 2.5 mg/mL 1 250 10,000 Diluted solution may be stored at room temperature or under refrigeration. Discard prepared solution after 24 hours at room temperature or under refrigeration. 2.2.

Warnings & precautions

Sourced from openFDA

• There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive Angiotensin II. Use concurrent venous thromboembolism (VTE) prophylaxis. ( 5.1 , 6.1 ) 5.1 Risk for Thrombosis The safety of Angiotensin II was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received Angiotensin II compared to placebo-treated patients in the ATHOS-3 study (13% vs. 5%). The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism (VTE) prophylaxis.

Adverse reactions

Sourced from openFDA

The most common adverse reactions reported in greater than 10% in Angiotensin II treated patients were thromboembolic events. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609)-250‐7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ATHOS-3 The safety of Angiotensin II was evaluated in ATHOS-3 [see Warnings and Precautions (5.1) ] . Patients in ATHOS-3 were receiving other vasopressors in addition to Angiotensin II or placebo, which were titrated to effect on mean arterial pressure (MAP). Table 2 summarizes adverse reactions with an incidence of at least 4% among patients treated with Angiotensin II and with a rate of at least 1.5% higher with Angiotensin II than with placebo. Table 2: Adverse Reactions Occurring in ≥ 4% of Patients Treated with Angiotensin II and ≥ 1.5% More Often than in Placebo-treated Patients in ATHOS-3 A dverse Event Angiotensin II N= 163 Placebo N= 158 Thromboembolic events a 21 (12.9%) 8 (5.1%) Deep vein thrombosis 7 (4.3%) 0 (0.0%) Thrombocytopenia 16 (9.8%) 11 (7.0%) Tachycardia 14 (8.6%) 9 (5.7%) Fungal infection 10 (6.1%) 2 (1.3%) Delirium 9 (5.5%) 1 (0.6%) Acidosis 9 (5.5%) 1 (0.6%) Hyperglycemia 7 (4.3%) 4 (2.5%) Peripheral ischemia 7 (4.3%) 4 (2.5%) a Including arterial and venous thrombotic events

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary The published data on angiotensin II use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Angiotensin II. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Septic or other distributive shock is a medical emergency that can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic or other distributive shock is likely to increase the risk of maternal and fetal morbidity and mortality. 8.2. Lactation Risk Summary It is not known whether Angiotensin II is present in human milk. No data are available on the effects of angiotensin II on the breastfed child or the effects on milk production. 8.4 Pediatric Use The safety and efficacy of Angiotensin II in pediatric patients have not been established. 8.5 Geriatric Use In ATHOS-3, 48% of the total patient population was aged 65 years and older.

Pharmacokinetics

Sourced from openFDA
Metabolism
Following intravenous infusion of angiotensin II in adults with septic or other distributive shock, serum levels of angiotensin II are similar at Baseline and Hour 3 after intravenous infusion. After 3 hours of treatment, however, the serum level of angiotensin I (the angiotensin II precursor peptide) is reduced by approximately 40%.

Overdosage

Sourced from openFDA

Overdose of Angiotensin II would be expected to result in hypertension, necessitating close monitoring and supportive care. Effects are expected to be brief because the half-life of angiotensin II is less than one minute.

Approval history

Sourced from openFDA
  • Dec 21, 2017NDANDA209360La Jolla Pharma
  • Jun 3, 2025ANDAANDA216966Gland

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
285 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective6724%
  2. 2Off Label Use2910%
  3. 3Acute Kidney Injury258.8%
  4. 4Death238.1%
  5. 5Peripheral Ischaemia176.0%
  6. 6Toxicity To Various Agents176.0%
  7. 7Hypotension165.6%
  8. 8Distributive Shock155.3%
  9. 9Intestinal Ischaemia155.3%
  10. 10Overdose144.9%
  11. 11Cardiogenic Shock124.2%
  12. 12Bradycardia113.9%
  13. 13Intentional Overdose113.9%
  14. 14Cardiac Arrest103.5%
  15. 15Deep Vein Thrombosis103.5%

Literature

View JSON

Recent PubMed references pinned to Angiotensin Ii as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 350 ClinicalTrials.gov registrations naming Angiotensin Ii as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Angiotensin Ii work?
Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein coupled-angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca 2+ /calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.
What is Angiotensin Ii used for?
According to FDA labeling, Angiotensin Ii carries indications including: Angiotensin II Injection increases blood pressure in adults with septic or other distributive shock. Angiotensin II Injection is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Angiotensin Ii?
Angiotensin Ii is classified as Other cardiac stimulants, Vasoconstrictor, G-Protein-linked Receptor Interactions, Increased Blood Pressure, Vasoconstriction.
What are the brand names for Angiotensin Ii?
Angiotensin Ii is marketed under brand names including Giapreza.
What are the contraindications for Angiotensin Ii?
Angiotensin Ii labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for angiotensin-ii is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients