ADVERSE EXPERIENCES
The incidence of adverse events during treatment with ADALAT CC in doses up to 90 mg daily were derived from multi-center placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on ADALAT CC and in 64 of the 126 patients on placebo. All adverse events reported during ADALAT CC therapy were tabulated independently of their causal relationship to medication.
The most common adverse event reported with ADALAT CC was peripheral edema. This was dose related and the frequency was 18% on ADALAT CC 30 mg daily, 22% on ADALAT CC 60 mg daily and 29% on ADALAT CC 90 mg daily versus 10% on placebo.
Other common adverse events reported in the above placebo-controlled trials include:
| ADALAT CC (%) | PLACEBO (%) |
| (n=370) | (n=126) |
| Adverse Event | | |
| Headache | 19 | 13 |
| Flushing/heat sensation | 4 | 0 |
| Dizziness | 4 | 2 |
| Fatigue/asthenia | 4 | 4 |
| Nausea | 2 | 1 |
| Constipation | 1 | 0 |
Where the frequency of adverse events with ADALAT CC and placebo is similar, causal relationship cannot be established.
The following adverse events were reported with an incidence of 3% or less in daily doses up to 90 mg:
Body as a Whole/Systemic: chest pain, leg pain
Central Nervous System: paresthesia, vertigo
Dermatologic: rash
Gastrointestinal: constipation
Musculoskeletal: leg cramps
Respiratory: epistaxis, rhinitis
Urogenital: impotence, urinary frequency
Other adverse events reported with an incidence of less than 1.0% were:
Body as a Whole/Systemic: allergic reaction, asthenia, cellulitis, substernal chest pain, chills, facial edema, lab test abnormal, malaise, neck pain, pelvic pain, pain, photosensitivity reaction
Cardiovascular: atrial fibrillation, bradycardia, cardiac arrest, extrasystole, hypotension, migraine, palpitations, phlebitis, postural hypotension, tachycardia, cutaneous angiectases
Central Nervous System: anxiety, confusion, decreased libido, depression, hypertonia, hypesthesia, insomnia, somnolence
Dermatologic: angioedema, petechial rash, pruritus, sweating
Gastrointestinal: abdominal pain, diarrhea, dry mouth, dysphagia, dyspepsia, eructation, esophagitis, flatulence, gastrointestinal disorder, gastrointestinal hemorrhage, GGT increased, gum disorder, gum hemorrhage, vomiting
Hematologic: eosinophilia, lymphadenopathy
Metabolic: gout, weight loss
Musculoskeletal: arthralgia, arthritis, joint disorder, myalgia, myasthenia
Respiratory: dyspnea, increased cough, rales, pharyngitis, stridor
Special Senses: abnormal vision, amblyopia, conjunctivitis, diplopia, eye disorder, eye hemorrhage, tinnitus
Urogenital/Reproductive: dysuria, kidney calculus, nocturia, breast engorgement, polyuria, urogenital disorder
The following adverse events have been reported rarely in patients given nifedipine in coat core or other formulations: allergenic hepatitis, alopecia, anaphylactic reaction, anemia, arthritis with ANA (+), depression, erythromelalgia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, hyperglycemia, jaundice, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, Stevens-Johnson syndrome, syncope, taste perversion, thrombocytopenia, toxic epidermal necrolysis, transient blindness at the peak of plasma level, tremor and urticaria.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ADALAT CC
Below is a sample of reports where side effects / adverse reactions may be related to Adalat CC. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Adalat CC side effects / adverse reactions in 78 year old male
Reported by a individual with unspecified qualification from Japan on 2007-07-03
Patient: 78 year old male weighing 68.0 kg (149.6 pounds)
Reactions: Renal Impairment, Dehydration
Suspect drug(s):
Olmetec (Olmesartan Medoxomil) (Tablet) (Olmesartan Medoxomil)
Dosage: 20 mg (20 mg,1 in 1 d),per oral
Administration route: Oral
Indication: Essential Hypertension
Start date: 2006-09-15
Adalat CC
Dosage: 10 mg (1 in 1 d),per oral
Administration route: Oral
Aldactazide-A
Dosage: 25 mg (1 in 1 d),per oral
Administration route: Oral
Propacall (Ticlopidine Hydrochloride) (Ticlopidine Hydrochloride)
Dosage: 100 mg (1 in 1 d),per oral
Administration route: Oral
Other drugs received by patient: Depas (Etizolam) (Etizolam); Paxil; Wypax (Lorazepam) (Lorazepam)
Possible Adalat CC side effects / adverse reactions in 45 year old female
Reported by a consumer/non-health professional from United States on 2007-07-20
Patient: 45 year old female
Reactions: Drug Exposure During Pregnancy, Gestational Diabetes, Cystitis
Suspect drug(s):
Adalat CC
Other drugs received by patient: Diovan
Possible Adalat CC side effects / adverse reactions in 51 year old female
Reported by a pharmacist from United States on 2007-10-08
Patient: 51 year old female weighing 53.0 kg (116.6 pounds)
Reactions: Blood Urea Increased, Blood Calcium Increased, Blood Creatinine Increased
Suspect drug(s):
Adalat PA
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Adalat CC
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Nifedipine
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Carbolith
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Other drugs received by patient: Orap; APO-Propranolol; PMS Docusate Sodium
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