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Consensi Side Effects

Generic Name: amlodipine / celecoxib

Note: This document contains side effect information about amlodipine / celecoxib. Some of the dosage forms listed on this page may not apply to the brand name Consensi.

For the Consumer

Applies to amlodipine/celecoxib: oral tablet

Warning

  • This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.
  • This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain that is new or worse.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Joint swelling.
  • Passing urine more often.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to amlodipine / celecoxib: oral tablet

General

The most commonly reported adverse events included infection, headache, edema, hypertension, and diarrhea.[Ref]

Nervous system

Amlodipine:

Common (1% to 10%): Dizziness, somnolence

Uncommon (0.1% to 1%): Syncope, hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo

Celecoxib:

Very common (10% or more): Headache (up to 15.8%)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Cerebral infarction

Frequency not reported: Hypertonia, hypoesthesia, migraine, paresthesia, vertigo, somnolence, cerebrovascular accident, syncope, ataxia

Postmarketing reports: Aseptic meningitis, dysgeusia, anosmia, fatal intracranial hemorrhage[Ref]

Other

Amlodipine:

Very common (10% or more): Edema (up to 14.6%)

Common (1% to 10%): Fatigue, asthenia

Uncommon (0.1% to 1%): Chest pain, malaise, pain, tinnitus

Celecoxib:

Common (1% to 10%): Peripheral edema, accidental injury, pyrexia, injury and poisoning

Frequency not reported: Chest pain, cyst not otherwise specified, edema generalized, face edema, fatigue, influenza-like symptoms, pain, peripheral pain, deafness, tinnitus, alkaline phosphatase increased, sudden death, blood culture positive[Ref]

Cardiovascular

Amlodipine:

Common (1% to 10%): Flushing, palpitation

Uncommon (0.1% to 1%): Arrhythmia, bradycardia, tachycardia, vasculitis, peripheral ischemia, hot flushes

Celecoxib:

Very common (10% or more): Hypertension (up to 12.5%)

Uncommon (0.1% to 1%): Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy, deep vein thrombosis

Frequency not reported: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction, hot flushes, palpitation, tachycardia, congestive heart failure, ventricular fibrillation, thrombophlebitis, blood pressure increased

Postmarketing reports: Vasculitis[Ref]

Gastrointestinal

Amlodipine:

Common (1% to 10%): Nausea, abdominal pain

Uncommon (0.1% to 1%): Constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia, dry mouth

Celecoxib:

Very common (10% or more): Diarrhea (up to 10.5%)

Common (1% to 10%): Dyspepsia, abdominal pain, nausea, flatulence, abdominal pain upper, vomiting, gastroesophageal reflux disease

Frequency not reported: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus, post-dental extraction alveolar osteitis, upper gastrointestinal ulcers[Ref]

Respiratory

Amlodipine:

Common (1% to 10%): Dyspnea

Uncommon (0.1% to 1%): Epistaxis

Celecoxib:

Common (1% to 10%): Upper respiratory infection, sinusitis, pharyngitis, rhinitis, nasopharyngitis, cough, dyspnea

Frequency not reported: Epistaxis, bronchitis, bronchospasm, bronchospasm aggravated, laryngitis, pneumonia, pulmonary embolism[Ref]

Musculoskeletal

Amlodipine:

Common (1% to 10%): Muscle cramps

Uncommon (0.1% to 1%): Arthralgia, arthrosis, myalgia, back pain, rigors

Celecoxib:

Common (1% to 10%): Back pain, arthralgia

Uncommon (0.1% to 1%): Epicondylitis, tendon rupture

Frequency not reported: Leg cramps, creatine phosphokinase increased, arthrosis, myalgia, synovitis, tendinitis, blood creatine phosphokinase increased[Ref]

Dermatologic

Amlodipine:

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Angioedema, erythema multiforme, rash erythematosus, rash maculopapular, sweating increased, purpura

Celecoxib:

Common (1% to 10%): Rash

Frequency not reported: Ecchymosis, alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematosus, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria, dermatitis contact

Postmarketing reports: Angioedema[Ref]

Psychiatric

Amlodipine:

Uncommon (0.1% to 1%): Insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization

Celecoxib:

Common (1% to 10%): Insomnia

Frequency not reported: Anxiety, depression, nervousness, suicide[Ref]

Ocular

Amlodipine:

Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain

Celecoxib:

Common (1% to 10%): Eye disorders

Uncommon (0.1% to 1%): Vitreous floaters, conjunctival hemorrhage[Ref]

Genitourinary

Amlodipine:

Common (1% to 10%): Sexual dysfunction

Uncommon (0.1% to 1%): Micturition frequency, micturition disorder, nocturia

Celecoxib:

Uncommon (0.1% to 1%): Ovarian cyst

Frequency not reported: Albuminuria, dysuria, hematuria, micturition frequency, bacteriuria present, hematuria present, proteinuria present, urine analysis abnormal[Ref]

Metabolic

Amlodipine:

Uncommon (0.1% to 1%): Anorexia, weight gain, weight decrease, hyperglycemia, thirst

Celecoxib:

Uncommon (0.1% to 1%): Blood potassium increased, blood sodium increased

Frequency not reported: Hypercholesterolemia, hyperglycemia, hypokalemia, weight increased, anorexia, appetite increased, blood glucose increased, blood uric acid increased

Postmarketing reports: Hypoglycemia, hyponatremia[Ref]

Hematologic

Amlodipine:

Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia

Celecoxib:

Uncommon (0.1% to 1%): Hemoglobin decreased by more than 2 g/dL, anemia

Frequency not reported: Thrombocythemia, thrombocytopenia, activated partial thromboplastin time prolonged, hematocrit decreased, hemoglobin decreased

Postmarketing reports: Agranulocytosis, aplastic anemia, pancytopenia, leucopenia[Ref]

Hepatic

Amlodipine:

Postmarketing reports: Jaundice, hepatic enzyme elevations

Celecoxib:

Common (1% to 10%): ALT or AST elevation of 1.2 to less than 3 times the upper limit of normal

Uncommon (0.1% to 1%): ALT or AST elevation of 3 or more times the upper limit of normal

Frequency not reported: Cholelithiasis, liver function tests abnormal, transaminase increased

Postmarketing reports: Liver necrosis, hepatitis, jaundice, hepatic failure[Ref]

Endocrine

Amlodipine:

Postmarketing reports: Gynecomastia

Celecoxib:

Uncommon (0.1% to 1%): Blood testosterone decreased[Ref]

Immunologic

Amlodipine:

Uncommon (0.1% to 1%): Allergic reaction

Celecoxib:

Very common (10% or more): Infection (up to 25%)

Uncommon (0.1% to 1%): Labyrinthitis

Frequency not reported: Hypersensitivity, allergic reaction, cellulitis, cystitis, peripheral gangrene, sepsis

Postmarketing reports: Anaphylactoid reaction[Ref]

Renal

Celecoxib:

Common (1% to 10%): Nephrolithiasis

Frequency not reported: BUN increased, non-protein nitrogen increased, creatinine increased, renal calculus, acute renal failure

Postmarketing reports: Interstitial nephritis[Ref]

References

1. "Product Information. Consensi (amlodipine-celecoxib)." Kitov Pharmaceuticals, NW Washington, AC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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