Applies to amlodipine / celecoxib: oral tablet.

Serious side effects

Along with its needed effects, amlodipine / celecoxib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amlodipine / celecoxib:

Less common

• Arm, back, or jaw pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain, discomfort, tightness, or heaviness
• cloudy urine
• cough
• cough producing mucus
• cracked, dry, scaly skin
• diarrhea
• difficult, burning, or painful urination
• difficulty in swallowing
• dizziness
• fainting
• fast or irregular breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• frequent urge to urinate
• headache, severe and throbbing
• heartburn
• increased sensitivity of the skin to sunlight
• itching, skin rash
• joint or muscle pain or stiffness
• loss of appetite
• loss of consciousness
• nausea
• nervousness
• noisy breathing
• nosebleed
• pain in the lower back
• pain or burning in the throat
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• redness or other discoloration of the skin
• severe sunburn
• slow heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach pain or tenderness
• sudden decrease in the amount of urine
• swelling of the eyes, eyelids, face, arms, or legs
• swelling, tenderness, warmth, blistering, crusting, irritation, itching, or reddening of the skin
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Rare

• Anxiety
• bloody nose
• bloating
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• chills
• cold, pale or a bluish skin color of the fingers or toes
• confusion
• constipation
• darkened urine
• decreased frequency or amount of urine
• dilated neck veins
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• gaseous stomach pain
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• indigestion
• irregular breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• numbness and tingling of the face, fingers, or toes
• pain in the arms, legs, or lower back, especially in the calves or heels upon exertion
• pale, bluish-colored, or cold hands or feet
• rapid, shallow breathing
• recurrent fever
• severe constipation
• severe stomach pain, cramping, or burning
• sores, welts, or blisters
• stomach fullness
• swollen glands
• unexplained weight loss
• vomiting of blood or material that looks like coffee grounds, severe and continuing
• weak or absent pulses in the legs
• weight gain
• yellow eyes or skin

Incidence not known

• Clay-colored stools
• cold sweats
• muscle pain or cramps
• nightmares
• seizures
• shakiness
• slurred speech
• stiff neck or back
• unpleasant breath odor
• upper right abdominal or stomach pain

Other side effects

Some side effects of amlodipine / celecoxib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Belching
• body aches or pain
• ear congestion
• loss of voice
• runny or stuffy nose

Less common

• Bleeding after defecation
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty in moving
• dryness of the throat
• excess air or gas in the stomach or bowels
• feeling of constant movement of self or surroundings
• frequent urge to defecate
• full feeling
• hearing loss
• hoarseness
• leg cramps
• loss or thinning of the hair
• pain or tenderness around the eyes and cheekbones
• passing gas
• sensation of spinning
• straining while passing stool
• stuffy nose
• swelling or inflammation of the mouth
• trouble sleeping
• uncomfortable swelling around the anus
• voice changes

Rare

• Abnormal ejaculation
• burning, dry, or itching eyes
• decreased sexual performance or desire
• discharge, excessive tearing
• double vision
• eye pain
• feeling unusually cold
• lack or loss of strength
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• seeing double
• shivering
• unsteadiness, trembling, or other problems with muscle control or coordination
• unsteady walk

Incidence not known

• Loss of sense of smell or taste
• swelling of the breasts or breast soreness in both females and males

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]