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
- 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:
- Stomach pain or heartburn.
- Feeling dizzy, sleepy, tired, or weak.
- Signs of a common cold.
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
Common (1% to 10%): Dizziness, somnolence
Very common (10% or more): Headache (up to 15.8%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Cerebral infarction
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
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]
Common (1% to 10%): Flushing, palpitation
Very common (10% or more): Hypertension (up to 12.5%)
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]
Very common (10% or more): Diarrhea (up to 10.5%)
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]
Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Epistaxis
Common (1% to 10%): Upper respiratory infection, sinusitis, pharyngitis, rhinitis, nasopharyngitis, cough, dyspnea
Common (1% to 10%): Muscle cramps
Uncommon (0.1% to 1%): Arthralgia, arthrosis, myalgia, back pain, rigors
Common (1% to 10%): Back pain, arthralgia
Uncommon (0.1% to 1%): Epicondylitis, tendon rupture
Common (1% to 10%): Pruritus, rash
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]
Common (1% to 10%): Insomnia
Frequency not reported: Anxiety, depression, nervousness, suicide[Ref]
Common (1% to 10%): Eye disorders
Uncommon (0.1% to 1%): Vitreous floaters, conjunctival hemorrhage[Ref]
Common (1% to 10%): Sexual dysfunction
Uncommon (0.1% to 1%): Micturition frequency, micturition disorder, nocturia
Uncommon (0.1% to 1%): Ovarian cyst
Uncommon (0.1% to 1%): Anorexia, weight gain, weight decrease, hyperglycemia, thirst
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
Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia
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: Jaundice, hepatic enzyme elevations
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
Postmarketing reports: Liver necrosis, hepatitis, jaundice, hepatic failure[Ref]
Postmarketing reports: Gynecomastia
Uncommon (0.1% to 1%): Allergic reaction
Very common (10% or more): Infection (up to 25%)
Uncommon (0.1% to 1%): Labyrinthitis
Postmarketing reports: Anaphylactoid reaction[Ref]
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]
1. "Product Information. Consensi (amlodipine-celecoxib)." Kitov Pharmaceuticals, NW Washington, AC.
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.
More about Consensi (amlodipine / celecoxib)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- En Español
- 3 Reviews
- Drug class: cox-2 inhibitors
- FDA Alerts (1)
- FDA Approval History