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Duexis

Duexis

Duexis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Duexis (ibuprofen and famotidine) is used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Side effects may include stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, or dizziness. Duexis can cause serious or fatal side effects including heart attack, stroke, gastrointestinal bleeding or ulceration, and perforation of the stomach or intestines.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Duexis FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in 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

DUEXIS (ibuprofen and famotidine) tablets 800 mg/26.6 mg administered orally three times per day. Ibuprofen 800 mg administered orally three times per day.

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: hyoptension

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

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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