Advil Cold and Sinus Side Effects

Generic Name: ibuprofen / pseudoephedrine

Note: This page contains information about the side effects of ibuprofen / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Advil Cold and Sinus.

Not all side effects for Advil Cold and Sinus 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 ibuprofen / pseudoephedrine: capsules, tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur while taking ibuprofen / pseudoephedrine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; tremor; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of skin or eyes.

For Healthcare Professionals

Applies to ibuprofen / pseudoephedrine: oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects of ibuprofen may occur in up to 25% of patients, are usually mild and transient, and include dyspepsia, nausea, diarrhea, abdominal pain, and flatulence. More serious gastrointestinal effects of ibuprofen are uncommon but include occult blood loss, ulcer, gastrointestinal hemorrhage with or without perforation, and pancreatitis. In addition, a case of ibuprofen-associated colitis has been reported.

Pseudoephedrine may also cause gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat may occur in up to 15% of patients.[Ref]

The incidence of gastrointestinal blood loss with ibuprofen is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg per day.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effect. Ibuprofen should be used with caution in these patients.[Ref]

Renal

Renal side effects including new or worsened renal insufficiency has commonly been associated with the use of nonsteroidal anti-inflammatory drugs. Patients at higher risk of developing renal insufficiency during therapy include the elderly, patients with preexisting renal insufficiency, and any patients with a history of heart failure or renal artery stenosis. Rarer renal side effects associated with the use of ibuprofen include the nephrotic syndrome with and without renal failure and acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis.[Ref]

Ibuprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.[Ref]

Cardiovascular

Cardiovascular side effects of ibuprofen include peripheral edema (1% to 3%) and elevated blood pressure (less than 1%). These problems may be important in some patients with preexisting hypertension or congestive heart failure.

Cardiovascular adverse effects associated with pseudoephedrine may include a significant rise in heart rate. Hypertension and arrhythmias may be problematic in susceptible patients.[Ref]

A rare case of painful, persistent peripheral cyanosis and swelling of the fingers and toes which progressed to desquamation and digital pitting infarctions has been associated with ibuprofen.

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Nervous system

The incidence of aseptic meningitis associated with ibuprofen is higher in patients with systemic lupus erythematosus and other connective tissue disease, although it has been reported in patients without such underlying disease states.[Ref]

Central nervous system side effects of ibuprofen are rare and have included headache, drowsiness, and dizziness. Aseptic meningitis, paresthesias, and pseudotumor cerebri have rarely been associated with the use of ibuprofen.

Pseudoephedrine produces nervous system stimulation, resulting in tremor, anxiety, and nervousness. Headache or insomnia has been reported in up to 30% of patients.[Ref]

Hepatic

Elevations in liver function tests three times normal values occur in less than 1% of patients treated with ibuprofen. Ibuprofen-induced hepatitis has been associated with a fatal outcome in some cases.[Ref]

Hepatic side effects have included elevations in liver function tests in up to 15% of patients. Rarely, jaundice, cholestasis, hepatitis, and hepatic failure have been reported. Ibuprofen has also been implicated in the so-called acute vanishing bile duct syndrome in children and in cases of acute hepatitis in patients with established stable, chronic hepatitis C infection.[Ref]

Metabolic

Metabolic side effects of ibuprofen include hyponatremia and the Syndrome of Inappropriate Antidiuretic Hormone (SIADH), gynecomastia, hypoglycemia, and metabolic acidosis.[Ref]

Hypersensitivity

Hypersensitivity reactions to ibuprofen include erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions. Patients who are at higher risk of hypersensitivity reactions to ibuprofen include those with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis and diffuse pulmonary infiltrates, have also been reported.

Hypersensitivity reactions to pseudoephedrine may also occur. Fixed drug eruptions secondary to pseudoephedrine have been reported.[Ref]

Hematologic

Hematologic side effects of ibuprofen include platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit.[Ref]

Reductions in serum hemoglobin concentrations are uncommon and are usually associated with occult gastrointestinal blood loss. Rare cases of ibuprofen-associated hemolytic anemia, autoimmune thrombocytopenia, and leukopenia have been reported.[Ref]

Respiratory

Respiratory side effects including noncardiogenic pulmonary edema have been associated with the use of ibuprofen.[Ref]

Acute noncardiogenic pulmonary edema developed on two occasions in an HIV-positive patient. Infectious as well as cardiac etiologies were excluded. A close temporal relationship with the administration of ibuprofen and onset of symptoms was noted.[Ref]

Dermatologic

Dermatologic reactions associated with the use of ibuprofen are uncommon but include maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, Stevens-Johnson syndrome, alopecia, toxic epidermal necrolysis, and photosensitivity reactions.[Ref]

Other

Other side effects associated with the use of ibuprofen include tinnitus (1% to 3%), vertigo, blurred vision (less than 1%), scotomata, and diplopia.[Ref]

References

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2. Davies EF, Avery GS "Ibuprofen: a review of its pharmacological properties and therapeutic efficacy in rheumatic disorders." Drugs 2 (1971): 440-6

3. Stroh JE, Jr Ayars GH, Bernstein IL, Kemp JP, Podleski WK, Prenner BM, Schoenwetter WF, Salzmann JK "A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis." J Int Med Res 16 (1988): 420-7

4. Clements D, Williams GT, Rhodes J "Colitis associated with ibuprofen." Br Med J 301 (1990): 987

5. Poitirt TI "Reversible renal failure associated with ibuprofen: case report and review of the literature." Drug Intell Clin Pharm 18 (1984): 27-32

6. Moss AH, Riley R, Murgo A, Skaff LA "Over-the-counter ibuprofen and nephrotic syndrome." Ann Intern Med 105 (1986): 303

7. Marasco WA, Gikas PW, Azziz-Baumgartner R, et al "Ibuprofen-associated renal dysfunction: pathophysiologic mechanisms of acute renal failure, hyperkalemia, tubular necrosis, and proteinuria." Arch Intern Med 147 (1987): 2107-16

8. Blackshear JL, Davidman M, Stillman MT "Identification of risk for renal insufficiency from nonsteroidal anti-inflammatory drugs." Arch Intern Med 143 (1983): 1130-4

9. Rogers SY, Venning MC "Reversible acute renal failure precipitated by overdose of ibuprofen and salbutamol." Lancet 1 (1986): 737-8

10. Morgenstern SJ, Bruns FJ, Fraley DS, et al "Ibuprofen-associated lipoid nephrosis without interstitial nephritis." Am J Kidney Dis 14 (1989): 50-2

11. Bonney SL, Northington RS, Hedrich DA, Walker BR "Renal safety of two analgesics used over the counter: ibuprofen and aspirin." Clin Pharmacol Ther 40 (1986): 373-7

12. Fong HJ, Cohen AH "Ibuprofen-induced acute renal failure with acute tubular necrosis." Am J Nephrol 2 (1982): 28-31

13. Shah GM, Muhalwas KK, Winer RL "Renal papillary necrosis due to ibuprofen." Arthritis Rheum 24 (1981): 1208-10

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16. Gordon RD, Ballantine DM, Bachmann AW "Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma." Clin Exp Pharmacol Physiol 19 (1992): 287-90

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21. Radack KL, Deck CC, Bloomfield SS "Ibuprofen interferes with the efficacy of antihypertensive drugs: a randomized, double-blind, placebo-controlled trial of ibuprofen compared with acetaminophen." Ann Intern Med 107 (1987): 628-35

22. Wiener I, Tilkian AG, Palazzolo M "Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion." Cathet Cardiovasc Diagn 20 (1990): 51-3

23. Bouland DL, Specht NL, Hegstad DR "Ibuprofen and aseptic meningitis." Ann Intern Med 104 (1986): 731

24. Quinn JP, Weinstein RA, Caplan LR "Eosinophilic meningitis and ibuprofen therapy." Neurology 34 (1984): 108-9

25. Gilbert GJ, Eichenbaum HW "Ibuprofen-induced meningitis in an elderly patient with systemic lupus erythematosus." South Med J 82 (1989): 514-5

26. Durback MA, Freeman J, Schumacher HR Jr "Recurrent ibuprofen-induced aseptic meningitis: third episode after only 200 mg of generic ibuprofen." Arthritis Rheum 31 (1988): 813-5

27. Jensen S, Glud TK, Bacher T, Ersgaard H "Ibuprofen-induced meningitis in a male with systemic lupus erythematosus." Acta Med Scand 221 (1987): 509-11

28. Loizou LA, Hamilton JG, Tsementzis SA "Intracranial haemorrhage in association with pseudoephedrine overdose." J Neurol Neurosurg Psychiatry 45 (1982): 471-2

29. Peck MG, Joyner PU "Ibuprofen-associated aseptic meningitis." Clin Pharm 1 (1982): 561-5

30. Lawson JM, Grady MJ "Ibuprofen-induced aseptic meningitis in a previously healthy patient." West J Med 143 (1985): 386-7

31. Agus B, Nelson J, Kramer N, et al "Acute central nervous system symptoms caused by ibuprofen in connective tissue disease." J Rheumatol 17 (1990): 1094-6

32. Giansiracusa DF, Blumberg S, Kantrowitz FG "Aseptic meningitis associated with ibuprofen." Arch Intern Med 140 (1980): 1553

33. Rault RM "Case report: hyponatremia associated with nonsteroidal antiinflammatory drugs." Am J Med Sci 305 (1993): 318-20

34. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40

35. Lee RP, King EG, Russell AS "Ibuprofen: a severe systemic reaction." Can Med Assoc J 129 (1983): 854-5

36. Shelley WB, Shelley ED "Nonpigmenting fixed drug eruption as a distinctive reaction pattern: examples caused by sensitivity to pseudoephedrine hydrochloride and tetrahydrozoline." J Am Acad Dermatol 17 (1987): 403-7

37. Shelley ED, Shelley WB "Ibuprofen urticaria." J Am Acad Dermatol 17 (1987): 1057-8

38. Ayres JG, Fleming DM, Whittington RM "Asthma death due to ibuprofen." Lancet 05/09/87 (1987): 1082

39. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J "Systemic contact dermatitis from pseudoephedrine." Contact Dermatitis 24 (1991): 86-8

40. Hakala M, Timonen TT, Rossi O, et al "Agranulocytosis in a patient with psoriatic arthritis receiving auranofin and ibuprofen." Scand J Rheumatol 16 (1987): 375-6

41. Lindblad R, Rodjer S "A case of severe pancytopenia caused by ibuprofen." J Intern Med 229 (1991): 281-3

42. Chetty KG, Ramirez MM, Mahutte CK "Drug-induced pulmonary edema in a patient infected with human immunodeficiency virus." Chest 104 (1993): 967-9

43. Bergner T, Przybilla B "Photosensitization caused by ibuprofen." J Am Acad Dermatol 26 (1992): 114-6

44. Laing VB, Sherertz EF, Flowres FP "Pemphigoid-like bullous eruption related to ibuprofen." J Am Acad Dermatol 19 (1988): 91-4

45. Halpern SM, Volans GN "Cutaneous toxicity of ibuprofen." Arch Dermatol 130 (1994): 259-60

46. Bar-Sela S, Levo Y, Zeevi D, et al "A lupus-like syndrome due to ibuprofen hypersensitivity." J Rheumatol 7 (1980): 379-80

47. Asherov J, Schoenberg A, Weinberger A "Diplopia following ibuprofen administration." JAMA 248 (1982): 649

48. Tullio CJ "Ibuprofen-induced visual disturbance." Am J Hosp Pharm 38 (1981): 1362

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