Azor Side Effects
Generic Name: amlodipine / olmesartan
Note: This page contains information about the side effects of amlodipine / olmesartan. Some of the dosage forms included on this document may not apply to the brand name Azor.
Not all side effects for Azor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to amlodipine / olmesartan: oral tablet
In addition to its needed effects, some unwanted effects may be caused by amlodipine / olmesartan. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking amlodipine / olmesartan:More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- Fast, irregular, pounding, or racing heartbeat or pulse
- unusual tiredness or weakness
- Abdominal or stomach pain
- dark urine
- decreased urine output
- itching skin or rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- muscle pain or stiffness
- upper right abdominal or stomach pain
- yellow eyes or skin
Some of the side effects that can occur with amlodipine / olmesartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Less common
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
- sleepiness or unusual drowsiness
- Hives or welts
- redness of the skin
For Healthcare Professionals
Applies to amlodipine / olmesartan: oral tablet
Worsened angina has been rarely associated with the use of amlodipine (as with other calcium channel blockers).[Ref]
Cardiovascular side effects associated with amlodipine are dose-related, are usually the result of vasodilation, and include flushing in less than 1% and peripheral edema in 2% of patients. Peripheral edema may become a chronic problem, and has occurred in up to 10% of patients who are receiving 10 mg doses. Palpitations occur in 1% to 5% of patients. Recent data have shown that the use of amlodipine in patients with NYHA Class III or IV heart failure is not associated with worsened heart failure. Bradycardia, hypotension, and syncope have been reported in less than 1% of patients. Generalized edema has also been reported rarely.
Cardiovascular side effects associated with olmesartan including tachycardia, chest pain, and peripheral edema have been reported in 0.5% to 1% of patients. At least 5 cases of facial edema and at least one case of olmesartan-induced angioedema, which resolved over 7 to 10 days after discontinuing olmesartan, have been reported.[Ref]
A case study reports a 34-year-old woman with a history of chronic renal failure secondary to glomerulonephritis, who was started on amlodipine for uncontrolled hypertension. Three days later the patient developed severe thrombocytopenia. After discontinuation of the drug, the platelet count returned to normal.[Ref]
Hematologic side effects associated with amlodipine have included isolated cases of thrombocytopenia.
Hematologic side effects associated with olmesartan have included decreased hemoglobin and hematocrit.[Ref]
Nervous system side effects associated with amlodipine have included headache (8%), dizziness (3%), and fatigue (5%). Vertigo, tremors, and paresthesias have been reported in less than 1% of patients receiving amlodipine.
Nervous system side effects associated with olmesartan have included dizziness (3% vs. 1% with placebo), vertigo (0.5% to 1% with placebo), and insomnia (0.5% to 1% with placebo). Asthenia has been reported in postmarketing experience.[Ref]
Respiratory side effects associated with olmesartan have included cough (0.9% vs. 0.7% with placebo), bronchitis, rhinitis, pharyngitis, sinusitis, and upper respiratory tract infection.[Ref]
Hepatic side effects including jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) have been reported with amlodipine use. In some instances, these cases were severe enough to require hospitalization.
Hepatic side effects associated with olmesartan have rarely included liver enzyme and serum bilirubin elevations.[Ref]
Metabolic side effects associated with olmesartan have included hyperglycemia and hypertriglyceridemia.[Ref]
Hypersensitivity reactions have rarely been reported, although experience with amlodipine is limited. A single case of erythema multiforme during amlodipine therapy has been reported.
Hypersensitivity side effects including rare cases of angioedema have been reported in patients receiving olmesartan.
Hypersensitivity reactions reported postmarketing have included anaphylactic reactions and peripheral edema.[Ref]
A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine. The rash resolved upon substitution with nifedipine.[Ref]
Calcium channel blockers have been suggested as possibly unsafe in patients with acute porphyria.[Ref]
Other side effects including a single case of acute porphyria exacerbation have been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient.[Ref]
Renal side effects have been reported rarely with amlodipine use. At least one case of interstitial nephritis has been associated with amlodipine therapy.
Renal side effects associated with ACE inhibitors have included increases in serum creatinine or BUN in patients with renal artery stenosis. Acute renal failure and increased serum creatinine levels have been reported in postmarketing experience.[Ref]
Musculoskeletal side effects including arthralgia, arthritis, myalgia, and skeletal pain have been reported in 0.5% to 1% of patients receiving olmesartan. Rhabdomyolysis has been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.[Ref]
Gastrointestinal side effects including nausea have been associated with amlodipine in 3% of patients.
Gastrointestinal side effects including abdominal pain, dyspepsia, gastroenteritis, and nausea have been reported in 0.5% to 1% of patients receiving olmesartan. Vomiting has been reported in postmarketing experience. Diarrhea has been reported in more than 1% of patients but at the same or greater incidence than placebo.[Ref]
Anorexia, constipation, dyspepsia, vomiting, flatulence, and diarrhea have been reported in less than 1% of patients. As with some other calcium channel blockers, rare cases of gingival hyperplasia have been associated with amlodipine. At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge.[Ref]
Dermatologic side effects including amlodipine-associated lichen planus and telangiectasia have been rarely reported.
Dermatologic side effects associated with olmesartan have included rash (0.5% to 1%), alopecia, pruritus, and urticaria.[Ref]
Endocrine side effects including a single case of gynecomastia have been associated with the use of amlodipine.[Ref]
The patient's gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent. The use of amlodipine has not been associated with adverse effects on glucose metabolism or serum lipids.[Ref]
Genitourinary side effects including gynecomastia have been reported in postmarketing experience with amlodipine.
Genitourinary side effects including urinary tract infection have been reported in 0.5% to 1% of patients receiving olmesartan. Hematuria has been reported in more than 1% of patients but at the same or greater incidence than placebo.[Ref]
1. Zidek W, Spiecker C, Knaup G, Steindl L, Breuer HWM "Comparison of the efficacy and safety of nifedipine coat-core versus amlodipine in the treatment of patients with mild-to-moderate essential hypertension." Clin Ther 17 (1995): 686-700
2. Frishman WH, Ram CVS, Mcmahon FG, Chrysant SG, Graff A, Kupiec JW, Hsu H "Comparison of amlodipine and benazepril monotherapy to amlodipine plus benazepril in patients with systemic hypertension: a randomized, double-blind, placebo-controlled, parallel-group study." J Clin Pharmacol 35 (1995): 1060-6
3. "Product Information. Benicar (olmesartan)." Sankyo Parke Davis, Parsippany, NJ.
4. Kloner RA, Sowers JR, Dibona GF, Gaffney M, Wein M "Sex- and age-related antihypertensive effects of amlodipine." Am J Cardiol 77 (1996): 713-22
5. Ezekowitz MD, Hossak K, Mehta JL, Thadani U, Weidler DJ, Kostuk W, Awan N, Grossman W, Bommer W "Amlodipine in chronic stable angina: results of a multicenter double-blind crossover trial." Am Heart J 129 (1995): 527-35
6. Johnson BF, Frishman WH, Brobyn R, Brown RD, Reeves RL, Wombolt DG "A randomized, placebo-controlled, double-blind comparison of amlodipine and atenolol in patients with essential hypertension." Am J Hypertens 5 (1992): 727-32
7. Kaplan NM "Amlodipine in the treatment of hypertension." Postgrad Med J 67 Suppl 5 (1991): s15-9
8. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.
9. Nykamp D, Winter EE "Olmesartan medoxomil-induced angioedema." Ann Pharmacother 41 (2007): 518-20
10. "Product Information. Azor (amlodipine-olmesartan)." Daiichi Pharmaceuticals, Montvale, NJ.
11. Esin RA, Essien OE, Andy J "Amlodipine in the treatment of mild-to-moderate essential hypertension." Curr Ther Res Clin Exp 55 (1994): 1112-6
12. Meredith P, Elliott H "Clinical pharmacokinetics of amlodipine." Clin Pharmacokinet 22 (1992): 22-31
13. Omvik P, Thaulow E, Herland OB, Eide I, Midha R, Turner RR "Double-blind, parallel, comparative study on quality of life during treatment with amlodipine or enalapril in mild or moderate hypertensive patients: a multicentre study." J Hypertens 11 (1993): 103-13
14. Grandinetti O, Feraco E "Middle term evaluation of amlodipine vs nitrendipine: efficacy, safety and metabolic effects in elderly hypertensive patients." Clin Exp Hypertens 15 (1993): 197-210
15. Chahine RA, Feldman RL, Giles TD, Nicod P, Raizner AE, Weiss RJ, Vanov SK "Randomized placebo-controlled trial of amlodipine in vasospastic angina. Amlodipine Study 160 Group." J Am Coll Cardiol 21 (1993): 1365-70
16. Haria M, Wagstaff AJ "Amlodipine: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease." Drugs 50 (1995): 560-86
17. Elliott HL, Meredith PA "The clinical consequences of the absorption, distribution, metabolism and excretion of amlodipine." Postgrad Med J 67 (1991): s20-3
18. Brousil JA, Burke JM "Olmesartan medoxomil: An angiotensin II-receptor blocker." Clin Ther 25 (2003): 1041-55
19. Saruta T, Ishii M, Abe K, Iimura I "Efficacy and safety of amlodipine in hypertensive patients with renal dysfunction." Clin Cardiol 17 (1994): 317-24
20. Pehrsson SK, Tolagen K, Ulvenstam G "Efficacy and safety of amlodipine compared with diltiazem in patients with stable angina pectoris." Clin Drug Invest 11 (1996): 313-9
21. Opie LH "Profiles of calcium antagonists in cardiovascular disease with special reference to second-generation agents and amlodipine." Postgrad Med J 67 (1991): s2-8
22. Sener D, Halil M, Yavuz BB, Cankurtaran M, Ariogul S "Anasarca edema with amlodipine treatment." Ann Pharmacother 39 (2005): 761-3
23. Kubota K, Pearce GL, Inman WHW "Vasodilation-related adverse events in diltiazem and dihydropyridine calcium antagonists studied by prescription-event monitoring." Eur J Clin Pharmacol 48 (1995): 1-7
24. Vanderkrogt KP, Brand R, Dawson EC "Amlodipine versus extended-release felodipine in general practice: a randomized, parallel-group study in patients with mild-to-moderate hypertension." Curr Ther Res Clin Exp 57 (1996): 145-58
25. Andresdottir MB, vanHamersvelt HW, vanHelden MJ, vandeBosch WJHM, Valk IM, Huysmans FT "Ankle edema formation during treatment with the calcium channel blockers lacidipine and amlodipine: A single-centre study." J Cardiovasc Pharmacol 35 (2000): s25-30
26. Clavijo GA, De Clavijo IV, Weart CW "Amlodipine: a new calcium antagonist." Am J Hosp Pharm 51 (1994): 59-68
27. Weir MR, Prisant LM, Papademetriou V, Weber MA, Adegbile IA, Alemayehu D, Lefkowitz MP "Antihypertensive therapy and quality of life: influence of blood pressure reduction, adverse events, and prior antihypertensive therapy." Am J Hypertens 9 (1996): 854-9
28. Packer M, Oconnor CM, Ghali JK, Pressler ML, Carson PE, Belkin RN, Miller AB, Neuberg GW, Frid D, Wertheimer JH, Cropp A "Effect of amlodipine on morbidity and mortality in severe chronic heart failure." N Engl J Med 335 (1996): 1107-14
29. Usalan C, Erdem Y, Arici M, Altun B "Severe thrombocytopenia associated with amlodipine treatment." Ann Pharmacother 33 (1999): 1126-7
30. Bewley AP, Feher MD, Staughton RC "Erythema multiforme following substitution of amlopidine for nifedipine." BMJ 307 (1993): 241
31. Kepple A, Cernek PK "Amlodipine-induced acute intermittent porphyris exacerbation." Ann Pharmacother 31 (1997): 253
32. Ejaz AA, Fitzpatrick PM, Haley WE, Wasiluk A, Durkin AJ, Zachariah PK "Amlodipine besylate induced acute interstitial nephritis." Nephron 85 (2000): 354-6
33. Velussi M, Brocco E, Frigato F, Zolli M, Muollo B, Maioli M, Carraro A, Tonolo G, Fresu P, Cernigoi AM, Fioretto P, Nosadini R "Effects of cilazapril and amlodipine on kidney function in hypertensive NIDDM patients." Diabetes 45 (1996): 216-22
34. Sadasivam B, Jhaj R "Dysgeusia with amlodipine - a case report." Br J Clin Pharmacol 63 (2007): 253
35. Steele RM, Schuna AA, Schreiber RT "Calcium antagonist-induced gingival hyperplasia." Ann Intern Med 120 (1994): 663-4
36. Ellis JS, Seymour RA, Thomason JM, Monkman SC, Idle JR "Gingival sequestration of amlodipine and amlodipine-induced gingival overgrowth." Lancet 341 (1993): 1102-3
37. Grabczynska SA, Cowley N "Amlodipine induced-photosensitivity presenting as telangiectasia." Br J Dermatol 142 (2000): 1255-6
38. Swale VJ, McGregor JM "Amlodipine-associated lichen planus." Br J Dermatol 144 (2001): 920-1
39. Baggio E, Maraffi F, Montalto C, Conti D, Ravera E, Ottolini S, Gandini R "The effects of felodipine and amlodipine on glucose and lipid metabolism in patients affected by non-insulin-dependent diabetes mellitus and hypertension: a comparative, randomized, parallel-group study." Curr Ther Res Clin Exp 56 (1995): 1050-8
40. Zochling J, Large G, Fassett R "Gynaecomastia and amlodipine." Med J Aust 160 (1994): 807
More about Azor (amlodipine / olmesartan)
Related treatment guides
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.