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Concensi

Last reviewed on RxList: 6/8/2018
Concensi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/8/2018

Consensi (amlodipine and celecoxib) is a combination of a calcium channel blocker and a nonsteroidal anti-inflammatory drug (NSAID) indicated for patients for whom treatment with amlodipine for high blood pressure (hypertension) and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks (myocardial infarctions). Common side effects of Consensi include:

The starting dose of Consensi is 5 mg/200 mg (2.5 mg/200 mg for small, elderly, or frail patients or hepatic impairment) (amlodipine/celecoxib) orally once daily. Titrate to 5 mg/200 mg or 10 mg/200 mg once daily as needed for blood pressure control. Consensi may interact with anticoagulants, aspirin, SSRIs/SNRIs, ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, diuretics, digoxin, simvastatin, lithium, methotrexate, cyclosporine, other NSAIDs or salicylates, pemetrexed, fluconazole, rifampin, atomoxetine, and corticosteroids. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Consensi; it may harm a fetus. Use of NSAIDs, including Consensi is not recommended in pregnant women starting at 30 weeks of gestation (third trimester) due to the risk of birth defects. The drugs in Consensi pass into breast milk in small amounts. Consult your doctor before breastfeeding.

Our Consensi (amlodipine and celecoxib) Tablets 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

Slideshow: Exercises for Knee Osteoarthritis and Joint Pain See Slideshow
Concensi Professional Information

SIDE EFFECTS

The following 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]
  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Increased Angina or Myocardial Infarction [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]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Celecoxib Clinical Trials

Of the celecoxib-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with osteoarthritis, approximately 2,100 were patients with rheumatoid arthritis, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of celecoxib of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received celecoxib at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

Pre-Marketing Controlled Arthritis Trials

The table below lists all adverse events, regardless of causality, occurring in ≥2% of patients receiving celecoxib from 12 controlled studies conducted in patients with osteoarthritis or rheumatoid arthritis that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence.

Adverse Events Occurring in ≥2% of Celecoxib Patients from Pre-Marketing Controlled Arthritis Trials

  CBX
N=4146
Placebo
N=1864
NAP
N=1366
DCF
N=387
IBU
N=345
Gastrointestinal
Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0%
Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8%
Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8%
Flatulence 2.2% 1.0% 3.6% 4.1% 3.5%
Nausea 3.5% 4.2% 6.0% 3.4% 6.7%
Body as a whole
Back Pain 2.8% 3.6% 2.2% 2.6% 0.9%
Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5%
Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2%
Central, Peripheral Nervous System
Dizziness 2.0% 1.7% 2.6% 1.3% 2.3%
Headache 15.8% 20.2% 14.5% 15.5% 15.4%
Psychiatric
Insomnia 2.3% 2.3% 2.9% 1.3% 1.4%
Respiratory
Pharyngitis 2.3% 1.1% 1.7% 1.6% 2.6%
Rhinitis 2.0% 1.3% 2.4% 2.3% 0.6%
Sinusitis 5.0% 4.3% 4.0% 5.4% 5.8%
Upper Respiratory Infection 8.1% 6.7% 9.9% 9.8% 9.9%
Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2%
CBX = Celecoxib 100 - 200 mg twice daily or 200 mg once daily;
NAP = Naproxen 500 mg twice daily;
DCF = Diclofenac 75 mg twice daily;
IBU = Ibuprofen 800 mg three times daily

In placebo-or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the celecoxib treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of celecoxib patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.

The following adverse reactions occurred in 0.1 -1.9% of patients treated with celecoxib (100 -200 mg twice daily or 200 mg once daily):

Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting

Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction

General: Hypersensitivity, allergic reaction, chest pain, cyst not otherwise specified (NOS), edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain

Central, peripheral nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, paresthesia, vertigo

Hearing and vestibular: Deafness, tinnitus

Heart rate and rhythm: Palpitation, tachycardia

Liver and biliary: Hepatic enzyme increased [including serum glutamic oxaloacetic transaminase (SGOT) increased, serum glutamic pyruvic transaminase (SGPT) increased]

Metabolic and nutritional: BUN increased, creatine phosphokinase (CPK) increased, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen (NPN) increased, creatinine increased, alkaline phosphatase increased, weight increased

Musculoskeletal: Arthralgia, arthrosis, myalgia, synovitis, tendinitis

Platelets (bleeding or clotting): Ecchymosis, epistaxis, thrombocythemia

Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, somnolence

Hemic: Anemia

Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnea, laryngitis, pneumonia

Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria

Application site disorders: Cellulitis, dermatitis contact

Urinary: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus

The following serious adverse events (causality not evaluated) occurred in <0.1% of patients:

Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis

Gastrointestinal: Intestinal obstruction, intestinal perforation, GI bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus

General: Sepsis, sudden death

Liver and biliary: Cholelithiasis

Hemic and lymphatic: Thrombocytopenia

Nervous: Ataxia, suicide [see DRUG INTERACTIONS]

Renal: Acute renal failure

The Celecoxib Long-Term Arthritis Safety Study

[see Clinical Studies]

Hematological Events

The incidence of clinically significant decreases in hemoglobin (>2 g/dL) was lower in patients on celecoxib 400 mg twice daily (0.5%) compared to patients on either diclofenac 75 mg twice daily (1.3%) or ibuprofen 800 mg three times daily 1.9%. The lower incidence of events with celecoxib was maintained with or without ASA use [see CLINICAL PHARMACOLOGY].

Withdrawals/Serious Adverse Events

Kaplan-Meier cumulative rates at 9 months for withdrawals due to adverse events for celecoxib, diclofenac and ibuprofen were 24%, 29%, and 26%, respectively. Rates for serious adverse events (i.e., causing hospitalization or felt to be life-threatening or otherwise medically significant), regardless of causality, were not different across treatment groups (8%, 7%, and 8%, respectively).

Juvenile Rheumatoid Arthritis Study

In a 12-week, double-blind, active-controlled study, 242 juvenile rheumatoid arthritis patients 2 years to 17 years of age were treated with celecoxib or naproxen; 77 juvenile rheumatoid arthritis patients were treated with celecoxib 3 mg/kg twice daily, 82 patients were treated with celecoxib 6 mg/kg twice daily, and 83 patients were treated with naproxen 7.5 mg/kg twice daily. The most commonly occurring (≥5%) adverse events in celecoxib treated patients were headache, fever (pyrexia), upper abdominal pain, cough, nasopharyngitis, abdominal pain, nausea, arthralgia, diarrhea and vomiting. The most commonly occurring (≥5%) adverse experiences for naproxen-treated patients were headache, nausea, vomiting, fever, upper abdominal pain, diarrhea, cough, abdominal pain, and dizziness. Compared with naproxen, celecoxib at doses of 3 and 6 mg/kg twice daily had no observable deleterious effect on growth and development during the course of the 12-week double-blind study. There was no substantial difference in the number of clinical exacerbations of uveitis or systemic features of juvenile rheumatoid arthritis among treatment groups.

In a 12-week, open-label extension of the double-blind study described above, 202 juvenile rheumatoid arthritis patients were treated with celecoxib 6 mg/kg twice daily. The incidence of adverse events was similar to that observed during the double-blind study; no unexpected adverse events of clinical importance emerged.

Adverse Events Occurring in ≥5% of Juvenile Rheumatoid Arthritis Patients in Any Treatment Group, by System Organ Class (% of patients with events)

System Organ ClassPreferred Term All Doses Twice Daily
Celecoxib 3 mg/kg
N=77
Celecoxib 6 mg/kg
N=82
Naproxen 7.5 mg/kg
N=83
Any Event 64 70 72
Eye Disorders 5 5 5
Gastrointestinal 26 24 36
Abdominal pain NOS 4 7 7
Abdominal pain upper 8 6 10
Vomiting NOS 3 6 11
Diarrhea NOS 5 4 8
Nausea 7 4 11
General 13 11 18
Pyrexia 8 9 11
Infection 25 20 27
Nasopharyngitis 5 6 5
Injury and Poisoning 4 6 5
Investigations* 3 11 7
Musculoskeletal 8 10 17
Arthralgia 3 7 4
Nervous System 17 11 21
Headache NOS 13 10 16
Dizziness (excl vertigo) 1 1 7
Respiratory 8 15 15
Cough 7 7 8
Skin & Subcutaneous 10 7 18
*Abnormal laboratory tests, which include: Prolonged activated partial thromboplastin time, Bacteriuria NOS present, Blood creatine phosphokinase increased, Blood culture positive, Blood glucose increased, Blood pressure increased, Blood uric acid increased, Hematocrit decreased, Hematuria present, Hemoglobin decreased, Liver function tests NOS abnormal, Proteinuria present, Transaminase NOS increased, Urine analysis abnormal NOS

Other Pre-Approval Studies

Adverse Events From Ankylosing Spondylitis Studies

A total of 378 patients were treated with celecoxib in placebo-and active-controlled ankylosing spondylitis studies. Doses up to 400 mg once daily were studied. The types of adverse events reported in the ankylosing spondylitis studies were similar to those reported in the osteoarthritis/rheumatoid arthritis studies.

Adverse Events From Analgesia And Dysmenorrhea Studies

Approximately 1,700 patients were treated with celecoxib in analgesia and dysmenorrhea studies. All patients in post-oral surgery pain studies received a single dose of study medication. Doses up to 600 mg/day of celecoxib were studied in primary dysmenorrhea and post-orthopedic surgery pain studies. The types of adverse events in the analgesia and dysmenorrhea studies were similar to those reported in arthritis studies. The only additional adverse event reported was post-dental extraction alveolar osteitis (dry socket) in the post-oral surgery pain studies.

The APC And PreSAP Trials

Adverse Reactions From Long-Term, Placebo-Controlled Polyp Prevention Studies

Exposure to celecoxib in the Adenoma Prevention with Celecoxib (APC) and Prevention of Spontaneous Adenomatous Polyps (PreSAP) trials was 400 to 800 mg daily for up to 3 years [see Clinical Studies]. Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks; see Adverse Events from celecoxib pre-marketing controlled arthritis trials, above). The adverse reactions for which these differences in patients treated with celecoxib were greater as compared to the arthritis pre-marketing trials were as follows:

  Celecoxib (400 to 800 mg daily)
N=2285
Placebo
N=1303
Diarrhea 10.5% 7.0%
Gastroesophageal reflux disease 4.7% 3.1%
Nausea 6.8% 5.3%
Vomiting 3.2% 2.1%
Dyspnea 2.8% 1.6%
Hypertension 12.5% 9.8%
Nephrolithiasis 2.1% 0.8%

The following additional adverse reactions occurred in ≥0.1% and <1% of patients taking celecoxib, at an incidence greater than placebo in the long-term polyp prevention studies, and were either not reported during the controlled arthritis pre-marketing trials or occurred with greater frequency in the long-term, placebo-controlled polyp prevention studies:

Nervous system disorders: Cerebral infarction

Eye disorders: Vitreous floaters, conjunctival hemorrhage

Ear and labyrinth: Labyrinthitis

Cardiac disorders: Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy

Vascular disorders: Deep vein thrombosis

Reproductive system and breast disorders: Ovarian cyst

Investigations: Blood potassium increased, blood sodium increased, blood testosterone decreased

Injury, poisoning and procedural complications: Epicondylitis, tendon rupture

Amlodipine Clinical Trials

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:

  2.5 mg
N=275
Amlodipine 5 mg
N=296
10 mg
N=268
Placebo
N=520
Edema 1.8 3.0 10.8 0.6
Dizziness 1.1 3.4 3.4 1.5
Flushing 0.7 1.4 2.6 0.0
Palpitation 0.7 1.4 4.5 0.6

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

  Amlodipine (%)
(N=1730)
Placebo (%)
(N=1250)
Fatigue 4.5 2.8
Nausea 2.9 1.9
Abdominal Pain 1.6 0.3
Somnolence 1.4 0.6

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

  Amlodipine Placebo
Male=%
(N=1218)
Female=%
(N=512)
Male=%
(N=914)
Female=%
(N=336)
Edema 5.6 14.6 1.4 5.1
Flushing 1.5 4.5 0.3 0.9
Palpitations 1.4 3.3 0.9 0.9
Somnolence 1.3 1.6 0.8 0.3

+

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.

Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

General: allergic reaction, asthenia,1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System: arthralgia, arthrosis, muscle cramps,1 myalgia.

Psychiatric: sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Respiratory System: dyspnea,1 epistaxis.

Skin and Appendages: angioedema, erythema multiforme, pruritus,1 rash,1 rash erythematous, rash maculopapular.

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.

Urinary System: micturition frequency, micturition disorder, nocturia.

Autonomic Nervous System: dry mouth, sweating increased.

Metabolic and Nutritional: hyperglycemia, thirst.

Hemopoietic: leukopenia, purpura, thrombocytopenia.

1 These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, uric acid, BUN, or creatinine.

In patients with angiographically documented coronary artery disease [PREVENT study: 825 patients randomized to amlodipine (5-10 mg once daily) or placebo and followed for 3 years; CAMELOT study: 1318 patients randomized to amlodipine (5-10 mg once daily) or placebo in addition to standard care and followed for mean duration of 19 months], the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of either celecoxib or amlodipine. 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.

Celecoxib

Cardiovascular: Vasculitis, deep venous thrombosis

General: Anaphylactoid reaction, angioedema

Liver and biliary: Liver necrosis, hepatitis, jaundice, hepatic failure

Hemic and lymphatic: Agranulocytosis, aplastic anemia, pancytopenia, leucopenia

Metabolic: Hypoglycemia, hyponatremia

Nervous: Aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage

Renal: Interstitial nephritis

Amlodipine

The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.

Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.

Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Read the entire FDA prescribing information for Concensi (Amlodipine and Celecoxib Tablet)

QUESTION

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© Concensi Patient Information is supplied by Cerner Multum, Inc. and Concensi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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