Duexis Side Effects

Generic name: famotidine / ibuprofen

Note: This document contains side effect information about famotidine / ibuprofen. Some of the dosage forms listed on this page may not apply to the brand name Duexis.

Some side effects of Duexis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to famotidine / ibuprofen: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking famotidine / ibuprofen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking famotidine and ibuprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• sweating, trouble breathing, chest pain or discomfort that may spread to the arm, shoulder, back, or jaw;

• feeling short of breath, even with mild exertion;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe skin reaction -- fever, sore throat, redness or swelling in your face, redness or swelling of your hands or feet, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• bruising, severe tingling, numbness, pain, muscle weakness; or

• severe headache, neck stiffness, chills, increased sensitivity to light, and/or seizure (convulsions).

Less serious side effects of famotidine / ibuprofen may include:

• upset stomach, vomiting, diarrhea, constipation;

• bloating, gas;

• headache;

• throat irritation;

• blurred vision, changes in color vision; or

• mild back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to famotidine / ibuprofen: oral tablet

Cardiovascular

Cardiovascular side effects associated with famotidine have included decreases in stroke volume and cardiac output and may be clinically significant in patients with preexisting cardiac dysfunction. A variety of arrhythmias, including bradycardia, tachycardia, AV conduction defects (including AV block), and palpitations have also been reported rarely. Acquired long QT syndrome has been reported in at least three cases including a man with decompensated cirrhosis. Cardiovascular side effects associated with ibuprofen have included peripheral edema (1% to 3%) and elevated blood pressure (less than 1%). This may be important in some patients with preexisting hypertension or congestive heart failure. 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.

Dermatologic

Dermatologic side effects associated with famotidine have included alopecia, acne, pruritus, dry skin, and flushing. Dermatologic side effects associated with ibuprofen have been reported rarely. These have included maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, vasculitis, Stevens-Johnson syndrome, and alopecia. Photosensitivity reactions have been reported, although causality is unknown. At least one case of acute generalized exanthematous pustulosis has also been reported.

Endocrine

Endocrine side effects associated with famotidine have included antiandrogen effects of reversible hyperprolactinemia and gynecomastia.

Gastrointestinal

Gastrointestinal side effects associated with famotidine have included nausea, vomiting, diarrhea, constipation, abdominal discomfort, anorexia, and dry mouth. Gastrointestinal (GI) side effects associated with ibuprofen have been reported most frequently (up to 25% of patients). They have usually been mild and transient. They have included dyspepsia, nausea, vomiting, diarrhea, abdominal pain, and flatulence. More serious GI effects have been uncommonly reported and have included occult blood loss, ulcer, GI hemorrhage with or without perforation, and pancreatitis. In addition, small bowel enteropathies and ibuprofen-associated colitis have been reported. Bloody vomiting has occurred in overdose. Colonic and pyloric channel strictures have also been reported.

Hematologic

Hematologic side effects associated with famotidine have included neutropenia, and rarely, reversible thrombocytopenia, agranulocytosis, pancytopenia, and leucopenia. Hematologic side effects associated with ibuprofen have included platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit. At least one case of hemolytic uremic syndrome has also been reported.

Hepatic

Hepatic side effects associated with famotidine have included mild elevations of liver function tests. The clinical significance of these elevations is unknown. Jaundice and cholestatic jaundice have been reported infrequently. Cases of drug-induced hepatitis have also been reported. Hepatic side effects associated with ibuprofen 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.

Hypersensitivity

Hypersensitivity side effects associated with famotidine have infrequently included anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival infection, toxic epidermal necrolysis (very rare), erythema multiforme, and Stevens-Johnson syndrome (very rare). Hypersensitivity side effects associated with ibuprofen have included erythematous or urticaria rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions, particularly in patients with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis, diffuse pulmonary infiltrates, and Stevens-Johnson syndrome have been reported. Toxic epidermal necrolysis has also been reported, although causality is unknown. At least one case of an acute anaphylactic reaction has also been reported.

Metabolic

Metabolic side effects associated with ibuprofen have included hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH). In addition, gynecomastia, hypoglycemia, and acidosis have been reported, although causality is unknown. Hyperkalemia has occurred in ibuprofen overdose.

Musculoskeletal

Musculoskeletal side effects associated with famotidine have infrequently included musculoskeletal pain including muscle cramps and arthralgia.

Nervous system

Nervous system side effects associated with famotidine have included headache, dizziness, seizures, paresthesia, and somnolence. Nervous system side effects associated with ibuprofen have been reported rarely. These have included headache, drowsiness, and dizziness. Aseptic meningitis associated with ibuprofen has been described in several case reports. In addition, paresthesia and pseudotumor cerebri have been reported, although causality is unknown.

Ocular

Ocular side effects associated with ibuprofen have included blurred vision (less than 1%), scotomata, and diplopia. In addition, at least one case of corneal verticillata has also been reported during ibuprofen use.

Other

Other side effects associated with famotidine have infrequently included tinnitus, fever, asthenia, fatigue, and taste disorder. Other side effects associated with ibuprofen have included tinnitus (1% to 3%) and vertigo.

Psychiatric

Psychiatric side effects associated with famotidine have included depression, anxiety, insomnia, hallucinations, and decreased libido. Psychiatric side effects associated with ibuprofen have included case reports of pseudodementia and psychotic exacerbation.

Renal

Renal side effects associated with famotidine have included rare cases of interstitial nephritis. Renal side effects associated with ibuprofen have included mild renal insufficiency, urinary retention, nephrotic syndrome with or without renal failure, acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis.

Respiratory

Respiratory side effects associated with famotidine have rarely included bronchospasm and interstitial pneumonia. Respiratory side effects associated with ibuprofen have included noncardiogenic pulmonary edema.

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