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The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular events [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Gastrointestinal effects [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Renal injury [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis [see WARNINGS AND PRECAUTIONS]
  • Skin reactions [see WARNINGS AND PRECAUTIONS]
  • Corticosteroid treatment [see WARNINGS AND PRECAUTIONS]
  • Masking of inflammation and fever [see WARNINGS AND PRECAUTIONS]
  • Hepatic injury [see WARNINGS AND PRECAUTIONS]
  • Hematological effects [see WARNINGS AND PRECAUTIONS]
  • Pre-existing asthma [see WARNINGS AND PRECAUTIONS]
  • Aseptic meningitis [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)
* 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