Duexis

• Generic Name: ibuprofen and famotidine tablets
• Brand Name: Duexis

Duexis (Ibuprofen and Famotidine Tablets) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Duexis Side Effects Center

What Is Duexis?

Duexis (ibuprofen and famotidine) is a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a histamine H2-receptor antagonist used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers.

What Are Side Effects of Duexis?

Side effects of Duexis include:

• stomach pain,
• upset stomach,
• constipation,
• diarrhea,
• bloating,
• gas,
• heartburn,
• nausea,
• vomiting,
• dizziness,
• headache,
• throat irritation,
• blurred vision,
• changes in color vision, or
• back pain.

Duexis can cause serious or fatal side effects including:

• heart attack,
• stroke,
• gastrointestinal bleeding or ulceration, and
• perforation of the stomach or intestines.

Dosage for Duexis

Duexis is dosed as 800 mg/26.6 mg tablets, taken orally, three times per day.

What Drugs, Substances, or Supplements Interact with Duexis?

Duexis may interact with ACE-inhibitors. Duexis contains ibuprofen and may interact with anticoagulant medication such as Warfarin (Coumadin). Tell your doctor all medications you use.

Duexis During Pregnancy and Breastfeeding

Duexis should not be given to women in late stages of pregnancy. There is potential for adverse reactions in nursing infants; consult your doctor before breastfeeding.

Additional Information

Our Duexis (ibuprofen and famotidine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Duexis Consumer Information

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose; wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using ibuprofen and call your doctor at once if you have:

• changes in your vision;
• the first sign of any skin rash, no matter how mild;
• fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;
• severe headache, blurred vision, pounding in your neck or ears;
• little or no urination;
• swelling, rapid weight gain;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Some side effects may be more likely in older adults and in people who have severe kidney disease.

Common side effects may include:

• nausea, stomach pain;
• diarrhea, constipation; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Duexis (Ibuprofen and Famotidine Tablets)

 

Duexis Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration, and Perforation [see WARNINGS AND PRECAUTIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
• Aseptic Meningitis [see WARNINGS AND PRECAUTIONS]
• Ophthalmological Effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of DUEXIS was evaluated in 1022 patients in controlled clinical studies, including 508 patients treated for at least 6 months and 107 patients treated for approximately 1 year. Patients treated with DUEXIS ranged in age from 39 to 80 years (median age 55 years), with 67% female, 79% Caucasian, 18% African-American, and 3% other races. Two randomized, active-controlled clinical studies (Study 301 and Study 303) were conducted for the reduction of the risk of development of ibuprofen-associated, upper gastrointestinal ulcers in patients who required use of ibuprofen, which included 1022 patients on DUEXIS and 511 patients on ibuprofen alone. Approximately 15% of patients were on low- dose aspirin. Patients were assigned randomly, in a 2:1 ratio, to treatment with either DUEXIS or ibuprofen 800 mg three times a day for 24 consecutive weeks.

Three serious cases of acute renal failure were observed in patients treated with DUEXIS in the two controlled clinical trials. All three patients recovered to baseline levels after discontinuation of DUEXIS. Additionally, increases in serum creatinine were observed in both treatment arms in the two clinical studies. Many of these patients were taking concomitant diuretics and/or angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers. There were patients with a normal baseline serum creatinine level who developed abnormal values in the controlled trials as presented in Table 1.

Table 1: Shift Table of Serum Creatinine, Normal^* to Abnormal^† in Controlled Studies

Baseline	Post-Baseline‡	Study 301		Study 303
		DUEXIS N=414 % (n)	Ibuprofen N=207 % (n)	DUEXIS N=598 % (n)	Ibuprofen N=296 % (n)
Normal*	Abnormal†	4% (17)	2% (4)	2%(15)	4% (12)
* serum creatinine normal range is 0.5 – 1.4 mg/dL or 44-124 micromol/L † serum creatinine >1.4 mg/dL ‡ At any point after baseline level

Most Commonly Reported Adverse Reactions

The most common adverse reactions (≥2%), from pooled data from the two controlled studies are presented in Table 2.

Table 2: Incidence of Adverse Reactions in Controlled Studies

	DUEXIS N=1022	Ibuprofen N=511
	%	%
Blood and lymphatic system disorders
Anemia	2	1
Gastrointestinal disorders
Nausea	6	5
Dyspepsia	5	8
Diarrhea	5	4
Constipation	4	4
Abdominal pain upper	3	3
Gastroesophageal reflux disease	2	3
Vomiting	2	2
Stomach discomfort	2	2
Abdominal pain	2	2
General disorders and administration site conditions
Edema peripheral	2	2
Infections and infestations
Upper respiratory tract infection	4	4
Nasopharyngitis	2	3
Sinusitis	2	3
Bronchitis	2	1
Urinary tract infection	2	2
Influenza	2	2
Musculoskeletal and connective tissue disorders
Arthralgia	1	2
Back pain	2	1
Nervous system disorders
Headache	3	3
Respiratory, thoracic and mediastinal disorders
Cough	2	2
Pharyngolaryngeal pain	2	1
Vascular disorders
Hypertension	3	2

In controlled clinical studies, the discontinuation rate due to adverse events for patients receiving DUEXIS and ibuprofen alone were similar. The most common adverse reactions leading to discontinuation from DUEXIS therapy were nausea (0.9%) and upper abdominal pain (0.9%).

There were no differences in types of related adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.

Postmarketing Experience

Ibuprofen

The following adverse reactions have been identified during post-approval use of ibuprofen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system:

Cardiac disorders: myocardial infarction

Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain

General disorders and administration site conditions: pyrexia, pain, fatigue, asthenia, chest pain, drug ineffective, edema peripheral

Musculoskeletal and connective tissue disorders: arthralgia

Nervous system disorders: headache, dizziness

Psychiatric disorders: depression, anxiety

Renal and urinary disorders: renal failure acute

Respiratory, thoracic, and mediastinal disorders: dyspnea

Vascular disorders: hypertension

Famotidine

The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system:

Blood and lymphatic system disorders: anemia, thrombocytopenia

Gastrointestinal disorders: nausea, diarrhea, vomiting, abdominal pain

General disorders and administration site conditions: pyrexia, condition aggravated, asthenia, drug ineffective, chest pain, fatigue, pain, edema peripheral

Hepatobiliary disorders: hepatic function abnormal

Infections and infestations: pneumonia, sepsis

Investigations: platelet count decreased, aspartate aminotransferase increased, alanine aminotransferase increased, hemoglobin decreased

Metabolism and nutrition disorders: decreased appetite

Nervous system disorders: dizziness, headache

Respiratory, thoracic, and mediastinal disorders: dyspnea

Vascular disorders: hypotension

DRUG INTERACTIONS

See Table 3 for clinically significant drug interactions with ibuprofen.

Table 3: Clinically Significant Drug Interactions with Ibuprofen and Famotidine

Drugs That Interfere with Hemostasis
Clinical Impact:	Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention:	Monitor patients with concomitant use of DUEXIS with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].
Aspirin
Clinical Impact:	Pharmacodynamic (PD) studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric-coated low-dose aspirin. The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a oncedaily regimen of ibuprofen; however, this finding cannot be extended to enteric-coated lowdose aspirin [see CLINICAL PHARMACOLOGY]. Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervention:	Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking low-dose aspirin for cardioprotection who require analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics, where appropriate. Concomitant use of DUEXIS and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. DUEXIS is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers
Clinical Impact:	NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:	During concomitant use of DUEXIS and ACE-inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of DUEXIS and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS].
Diuretics
Clinical Impact:	Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of DUEXIS with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Digoxin
Clinical Impact:	The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Intervention:	During concomitant use of DUEXIS and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact:	NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of DUEXIS and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact:	Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:	During concomitant use of DUEXIS and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact:	Concomitant use of ibuprofen and cyclosporine may increase cyclosporine's nephrotoxicity.
Intervention:	During concomitant use of DUEXIS and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact:	Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].
Intervention:	The concomitant use of DUEXIS with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact:	Concomitant use of ibuprofen and pemetrexed may increase the risk of pemetrexedassociated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention:	During concomitant use of DUEXIS and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between permetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
Drugs Dependent on Gastric pH for Absorption
Clinical Impact:	Because famotidine lowers intra-gastric acidity, this may result in reduced absorption and loss of efficacy of concomitant drugs.
Intervention:	Concomitant administration of DUEXIS is not recommended with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir. For administration instructions of other drugs whose absorption is dependent on gastric pH, refer to their prescribing information (e.g., atazanavir, erlotinib, ketoconazole, itraconazole, nilotinib, ledipasvir/sofosbuvir, and rilpivirine).
Tizanidine (CYP1A2 Substrate)
Clinical Impact:	Famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate.
Intervention:	Avoid concomitant use with DUEXIS. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.

Read the entire FDA prescribing information for Duexis (Ibuprofen and Famotidine Tablets)

&Copy; Duexis Patient Information is supplied by Cerner Multum, Inc. and Duexis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.