Altace Side Effects

Generic Name: ramipril

Note: This page contains information about the side effects of ramipril. Some of the dosage forms included on this document may not apply to the brand name Altace.

Not all side effects for Altace 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 ramipril: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by ramipril (the active ingredient contained in Altace). 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 ramipril:

More common
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Less common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cloudy urine
  • cold sweats
  • decrease in urine output or decrease in urine-concentrating ability
  • fainting
  • fast or irregular heartbeat
  • nausea
  • shortness of breath

Some of the side effects that can occur with ramipril 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:

More common
  • Cough
Less common
  • Diarrhea
  • feeling of constant movement of self or surroundings
  • sensation of spinning
  • vomiting

For Healthcare Professionals

Applies to ramipril: oral capsule, oral tablet

General

Ramipril is generally well-tolerated. Most side effects are reported as often in patients taking placebo. Less than 3% of patients discontinue ramipril (the active ingredient contained in Altace) due to an adverse drug event.[Ref]

Nervous system

Nervous system side effects include headache, dizziness, and lightheadedness in 2% to 5% of patients. Asthenia and fatigue occur in 2% of patients.[Ref]

Cardiovascular

The exact mechanism by which ACE inhibitors produce angioedema is not well known, but is believed to involve stimulation of the kallikrein-kinin system, particularly in patients who are genetically or environmentally predisposed.[Ref]

Cardiovascular problems are limited mainly to hypotension in 0.5% of patients. Angioneurotic edema is reported in 0.1% to 0.5% of patients, and may be fatal.[Ref]

Gastrointestinal

Rare cases of abdominal pain associated with elevated enzymes suggestive of pancreatitis are reported.[Ref]

Gastrointestinal complaints of nausea or dyspepsia are reported in approximately 1% of patients. Rare problems include general abdominal pain or fullness, dry mouth, dysphasia, constipation, diarrhea, gastroenteritis, anorexia, vomiting, increased salivation, and dysgeusia.[Ref]

Respiratory

Several agents have been studied for treating cough with ACE inhibitors. No long term trials exist to allow a definitive treatment option. Cromolyn has the most data showing some benefit. Other agents studied include baclofen, theophylline, sulindac, and benzonatate.[Ref]

Respiratory side effects are limited to an idiosyncratic and reversible cough in approximately 3% of patients.[Ref]

Renal

Renal insufficiency occurs in approximately 1% to 2% of patients and is usually transient. In general, ACE inhibitor-induced renal insufficiency is much more likely in sodium- or intravascular volume-depleted patients, or in those patients on concomitant diuretic therapy.[Ref]

In one study of 13 patients with congestive heart failure, mean creatinine clearance increased during ramipril therapy.[Ref]

Metabolic

Ramipril (the active ingredient contained in Altace) has not been associated with deleterious changes in blood glucose or serum lipids in patients with diabetes mellitus.

Increases in serum potassium are associated with ACE inhibitors because they decrease aldosterone secretion, which usually promotes renal potassium excretion.

The mechanism of hyponatremia (rare) is unknown. Hyponatremia associated with ACE inhibitors presents like SIADH and may be due to inhibition of bradykinin metabolism or direct stimulation of ADH secretion by angiotensin II in the central nervous system (angiotensin I accumulates during ACE inhibitor therapy and crosses the blood-brain barrier).

Ramipril, like other ACE inhibitors does not appear to exert a significant effect on plasma glucose, insulin, or C-peptide levels.[Ref]

Metabolic changes include significant increases in serum potassium in 1% to 2% of patients. Extremely rare cases of hyponatremia have been associated with the use of ramipril (and other ACE inhibitors) in the elderly.[Ref]

Genitourinary

Genitourinary complaints are limited to impotence in 0.4% of patients.[Ref]

Hypersensitivity

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.[Ref]

Hypersensitivity reactions to angiotensin converting enzyme (ACE) inhibitors may be life threatening. Angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. In addition, intestinal angioedema has been reported in patients treated with ACE inhibitors. It is recommended that any patient with dyspnea, dysphagia, or significant facial angioedema stop therapy immediately and avoid ACE inhibitor therapy in general.

Dermatitis, pruritus, and photosensitivity have also been reported.[Ref]

Hematologic

ACE inhibitors have been used to treat post renal transplant erythrocytosis. Data have shown that they may decrease circulating erythropoietin levels in these patients.[Ref]

Hematologic side effects including agranulocytosis have been associated with ACE inhibitors including ramipril.[Ref]

Musculoskeletal

Musculoskeletal pains--both arthralgias and myalgias--have rarely been associated with the use of some ACE inhibitors, including ramipril (the active ingredient contained in Altace) [Ref]

Dermatologic

Dermatologic side effects are typically the result of hypersensitivity reactions. Rare cases of pemphigus, including lichen planus pemphigoides, have been associated with the use of ramipril (the active ingredient contained in Altace) and other ACE inhibitors. In addition, Stevens-Johnson syndrome has been associated with ramipril therapy.[Ref]

Drug-induced pemphigus has also been associated with a related drug, captopril. The mechanism remains unknown but drugs containing a thiol group may be involved as they are able to produce acantholysis of epidermal cells in vitro. Drugs containing an amide group have also been associated with pemphigus. These include enalapril which also induced acantholysis in vitro. (Four cases of enalapril-induced pemphigus have been reported.) Spontaneous remission of the skin lesions after drug withdrawal is less common with drugs containing the amide group compared with drugs containing the thiol group (15% vs. 50%).[Ref]

Hepatic

Hepatic side effects including hepatic failure, hepatitis, jaundice and pancreatitis have been reported rarely.[Ref]

References

1. Heidbreder D, Froer KL, Bauer B, Cairns V, Breitstadt A, Bender N "Combination of ramipril and hydrochlorothiazide in the treatment of mild to moderate hypertension--Part 2: An open long-term study of efficacy and safety." Clin Cardiol 16 (1993): 47-52

2. Schwartz SL, Hanson C, Lucas C, Rosenblatt S, Rosenstock J, Whittier F, Wistran D, Riche C, Mulcahy WS "Double-blind, placebo-controlled study of ramipril in diabetics with mild to moderate hypertension." Clin Ther 15 (1993): 79-87

3. Kaplan NM "The CARE study: a postmarketing evaluation of ramipril in 11,100 patients." Clin Ther 18 (1996): 658-70

4. Heidbreder D, Froer KL, Breitstadt A, Cairns V, Langley A, Bender N "Combination of ramipril and hydrochlorothiazide in the treatment of mild to moderate hypertension: Part 1--A double-blind, comparative, multicenter study in nonresponders to ramipril monotherapy." Clin Cardiol 15 (1992): 904-10

5. Ruddy MC, Mroczek WJ "Comparison of ramipril and enalapril in patients with essential hypertension." Pharmacotherapy 13 (1993): 224-8

6. "Product Information. Altace (ramipril)." Hoechst Marion-Roussel Inc, Kansas City, MO.

7. Framptom JE, Peters DH "Ramipril: an updated review of its therapeutic use in essential hypertension and heart failure." Drugs 49 (1995): 440-66

8. Genthon R, Rangoonwala B, Andrieuxlaclaveline A, Arnaud J, Ballade M, Billou J, Bosredon A, Boutges B, Dubon T, Goigoux B, Lalanne "Study of the efficacy and safety of the combination ramipril 2.5 mg plus hydrochlorothiazide 12.5 mg in patients with mild-to-moderate hypertension." Int J Clin Pharmacol Res 14 (1994): 1-9

9. Erhard W, Lindner U, Krall H, Breitstadt A, Pfeiffer C "Assessment of the efficacy, tolerance, and safety of ramipril in diabetic patients with mild-to-moderate hypertension: a retrospective analysis." J Cardiovasc Pharmacol 18 (1991): s160-4

10. Gonzalo FE, Montagut LB, Vecina ST "Angioedema caused by ramipril." Ann Pharmacother 29 (1995): 431-2

11. Fillastre JP, Baguet JC, Dubois T, Vauquier J, Godin M, Legallicier B, Luus HG, Delarey N, Carcone N, Genthon R "Kinetics, safety, and efficacy of ramipril after long-term administration in hemodialyzed patients." J Cardiovasc Pharmacol 27 (1996): 269-74

12. de Graeff PA, Kingma JH, Viersma JW, Wesseling H, Lie KI "Acute and chronic effects of ramipril and captopril in congestive heart failure." Int J Cardiol 23 (1989): 59-67

13. Singh S "Angiotensin-converting enzyme (ACE) inhibitor-induced acute pancreatitis: in search of the evidence." South Med J 99 (2006): 1327-8

14. Luque CA, Ortiz MV "Treatment of ACE inhibitor-induced cough." Pharmacotherapy 19 (1999): 804-10

15. Elliott WJ "Higher incidence of discontinuation of angiotensin converting enzyme inhibitors due to cough in black subjects." Clin Pharmacol Ther 60 (1996): 582-8

16. Heintz B, Verho M, Brockmeier D, Kirsten R, Nelson K, Maigatter S, Lefevre G, Kierdorf H, Sieberth HG "Influence of ramipril on renal function in patients with chronic congestive heart failure." J Cardiovasc Pharmacol 18 (1991): s174-9

17. Wynckel A, Ebikili B, Melin JP, Randoux C, Lavaud S, Chanard J "Long-term follow-up of acute renal failure caused by angiotensin converting enzyme inhibitors." Am J Hypertens 11 (1998): 1080-6

18. Herings RMC, Deboer A, Stricker BHC, Leufkens HGM, Porsius A "Hypoglycaemia associated with use of inhibitors of angiotensin converting enzyme." Lancet 345 (1995): 1195-8

19. Kindler J, Schunkert H, Gassmann M, Lahn W, Irmisch R, Debusmann ER, Ocon-Pujadas J, Ritz E, Sieberth HG "Therapeutic efficacy and tolerance of ramipril in hypertensive patients with renal failure." J Cardiovasc Pharmacol 13 (1989): s55-8

20. Heintz B, Verho M, Theobald KH, Frampton H "Efficacy and safety of ramipril in long-term treatment of congestive heart failure." Curr Ther Res Clin Exp 55 (1994): 489-99

21. Winkelmann BR, Haak T, Verho M, Kirsten DM, Nelson K, Ihnken K, Malerczyk C, Oremek G, Usadel KH "Ramipril in angina pectoris: short-term effects on glucose, insulin, c-peptide, adrenocorticotropic hormone, and cortisol levels." Curr Ther Res Clin Exp 57 (1996): 88-102

22. Tillygentric A "Severe hyponatremia associated with ramipril therapy in an old woman." J Am Geriatr Soc 43 (1995): 1448-9

23. Peppers MP "Myalgia and arthralgia associated with enalapril and ramipril." Am J Health Syst Pharm 52 (1995): 203-4

24. Murray A, Crowther J "ACE inhibitor use and severe angioedema." Postgrad Med J 74 (1998): 571-2

25. Gunkel AR, Thurner KH, Kanonier G, Sprinzl GM, Thumfart WF "Angioneurotic edema as a reaction to angiotensin-converting enzyme inhibitors." Am J Otolaryngol 17 (1996): 87-91

26. Lal SM, Trivedi HS, Ross G "Long term effects of ACE inhibitors on the erythrocytosis in renal transplant recipients." Int J Artif Organs 18 (1995): 13-6

27. Horowitz N, Molnar M, Levy Y, Pollack S "Ramipril-Induced Agranulocytosis Confirmed by a Lymphocyte Cytotoxicity Test." Am J Med Sci 329 (2005): 52-53

28. Zhu YI, Fitzpatrick JE, Kornfeld BW "Lichen planus pemphigoides associated with ramipril." Int J Dermatol 45 (2006): 1453-5

29. Vignes S, Paul C, Flageul B, Dubertret L "Ramipril-induced superficial pemphigus." Br J Dermatol 135 (1996): 657-8

30. "Stevens-Johnson Syndrome associated with Ramipril." Int J Dermatol 42 (2003): 580-581

31. Kanbay M, Korkmaz M, Yilmaz U, Gur G, Boyacioglu S "Acute pancreatitis due to ramipril therapy." Postgrad Med J 80 (2004): 617-8

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