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LOSARTAN POTASSIUM
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Post-Marketing Experience
- The following additional adverse reactions have been reported in post-marketing experience:
- Digestive: Hepatitis (reported rarely).
- General Disorders and Administration Site Conditions: Malaise.
- Hemic: Thrombocytopenia (reported rarely).
- Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported. Anaphylactic reactions have been reported.
- Metabolic and Nutrition: Hyperkalemia, hyponatremia have been reported with losartan.
- Musculoskeletal: Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
- Nervous system disorders: Dysgeusia
- Respiratory: Dry cough (see above).
- Skin: Erythroderma
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
268
42644
Other ADRs
11979
14105300
Odds Ratio = 7.401
Drug Property Information
ATC Code(s):
- C09DA01 - losartan potassium
- C09DA - Angiotensin II antagonists and diuretics
- C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
- C09DB06 - losartan potassium
- C09DB - Angiotensin II antagonists and calcium channel blockers
- C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
- C09CA01 - losartan potassium
- C09CA - "Angiotensin II antagonists, plain"
- C09C - "ANGIOTENSIN II ANTAGONISTS, PLAIN"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
Active Ingredient:losartan potassium
Active Ingredient UNII:3ST302B24A
Drugbank ID:DB00678
PubChem Compound:3961
CAS Number:114798-26-4
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 50.0 mg/day C09CA01
Chemical Structure: 
SMILE Code:
CCCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NNN=N4)CO)Cl
CCCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NNN=N4)CO)Cl
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: Losartan potassium/hydrochlorothiazide (Preminent®) and hyponatremia: case series of 40 patients.
[Kinoshita Hiroyuki,Kobayashi Kenichiro,Yaguramaki Touru,Yasuda Mutsuko,Fujiki Kazuhiko,Tomiyama Junji,Koga Nobunori,Yakushiji Fumiatsu]Hum Exp Toxicol.2011 Sep;30(9):1409-14. doi: 10.1177/0960327110387455. Epub 2010 Oct 25. PMID: 20974655
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