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Duexis

Last reviewed on RxList: 5/3/2019
Duexis Side Effects Center

Last reviewed on RxList 5/3/2019

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. 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:

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

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.

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.

SLIDESHOW

Rheumatoid Arthritis (RA) Symptoms & Treatment See Slideshow
Duexis Consumer Information

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

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, feeling short of breath.

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

  • changes in your vision;
  • shortness of breath (even with mild exertion);
  • swelling in your hands or feet, rapid weight gain, feeling tired or short of breath;
  • severe headache with neck stiffness, chills, and/or seizure (convulsions);
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, 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.

Common side effects may include:

  • heartburn, gas, nausea, stomach pain;
  • dizziness;
  • 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)

QUESTION

The term arthritis refers to stiffness in the joints. See Answer
Duexis Professional Information

SIDE EFFECTS

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

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)
* At any point after baseline level
** serum creatinine normal range is 0.5 - 1.4 mg/dL or 44-124 micromol/L
*** serum creatinine > 1.4 mg/dL

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

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

Related Resources for Duexis

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© 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.

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