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Adalat CC (Nifedipine) - Side Effects and Adverse Reactions

 
 



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, erectile dysfunction (ED)

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.



REPORTS OF SUSPECTED ADALAT CC SIDE EFFECTS / ADVERSE REACTIONS

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 considered as verified clinical evidence.

Possible Adalat CC side effects / adverse reactions in 75 year old male

Reported by a consumer/non-health professional from United States on 2012-02-21

Patient: 75 year old male

Reactions: Burn Oesophageal, Pain, Feeling Hot

Suspect drug(s):
Adalat CC



Possible Adalat CC side effects / adverse reactions in 51 year old male

Reported by a physician from Japan on 2012-02-28

Patient: 51 year old male weighing 80.0 kg (176.0 pounds)

Reactions: Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Suspect drug(s):
Adalat CC
    Dosage: 40 mg, bid
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2011-12-01

Adalat CC
    Dosage: 40 mg/once in morning
    Administration route: Oral
    Start date: 2011-11-26
    End date: 2011-11-26

Adalat CC
    Dosage: 40 mg, bid
    Administration route: Oral
    Start date: 2011-03-19
    End date: 2011-11-22

Adalat CC
    Dosage: 40 mg/day
    Administration route: Oral
    Start date: 2011-03-09
    End date: 2011-03-18

Adalat CC
    Dosage: 40 mg/once in evening
    Administration route: Oral
    Start date: 2011-11-30
    End date: 2011-11-30

Other drugs received by patient: Isosorbide Dinitrate; Adalat; Uralyt; Coniel; Losartan Potassium; Allopurinol; Ticlopidine HCL; Losartan Potassium; Diovan; Adalat; Adalat; Losartan Potassium; Acetylsalicylic Acid SRT; Lipitor; Lansoprazole



Possible Adalat CC side effects / adverse reactions in 75 year old male

Reported by a physician from United States on 2012-03-01

Patient: 75 year old male

Reactions: Airway Burns, Pain, Feeling Hot

Suspect drug(s):
Adalat CC



See index of all Adalat CC side effect reports >>

Drug label data at the top of this Page last updated: 2014-05-14

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