Adalat GITS 30 Adverse Reactions

Adverse drug reactions (ADRs) based on placebo-controlled studies with nifedipine sorted by CIOMS III categories of frequency (clinical trial database: nifedipine n=2661; placebo n=1486; status: February 22, 2006 and the ACTION study: nifedipine n=3825; placebo n=3840) are listed as follows:
ADRs listed under "common" were observed with a frequency below 3% with the exception of edema (9.9%) and headache (3.9%).
The frequencies of ADRs reported with nifedipine containing products are summarized in the following texts. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100) and rare (≥1/10,000 to <1/1000). The ADRs identified only during the ongoing post-marketing surveillance, and for which a frequency could not be estimated, are listed under "not known".
System Organ Class (MedDRA): Blood and Lymphatic System Disorders: Not known: Agranulocytosis, leukopenia.
Immune System Disorders: Uncommon: Allergic reaction, allergic edema/angioedema (including larynx edema which may result in life-threatening outcome). Rare: Pruritus, urticaria, rash. Not known: Anaphylactic/anaphylactoid reaction.
Psychiatric Disorders: Uncommon: Anxiety reactions, sleep disorders.
Metabolism and Nutrition Disorders: Not known: Hyperglycemia.
Nervous System Disorders: Common: Headache. Uncommon: Vertigo, migraine, dizziness, tremor. Rare: Paresthesia, dysesthesia. Not known: Hypoesthesia, somnolence.
Eye Disorders: Uncommon: Visual disturbances. Not known: Eye pain.
Cardiac Disorders: Uncommon: Tachycardia, palpitations. Not known: Chest pain (angina pectoris).
Vascular Disorders: Common: Edema, vasodilatation. Uncommon: Hypotension, syncope.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Nosebleed, nasal congestion. Not known: Dyspnea.
Gastrointestinal Disorders: Common: Constipation. Uncommon: Gastrointestinal and abdominal pain, nausea, dyspepsia, flatulence, dry mouth. Rare: Gingival hyperplasia. Not known: Bezoar, dysphagia, intestinal obstruction, intestinal ulcer, vomiting, gastroesophageal sphincter insufficiency.
Hepatobiliary Disorders: Uncommon: Transient increase in liver enzymes. Not known: Jaundice.
Skin and Subcutaneous Tissue Disorders: Uncommon: Erythema. Not known: Toxic epidermal necrolysis, photosensitivity allergic reaction, palpable purpura.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps, joint swelling. Not known: Arthralgia, myalgia.
Renal and Urinary Disorders: Uncommon: Polyuria, dysuria.
Reproductive System and Breast Disorders: Uncommon: Erectile dysfunction.
General Disorders and Administration Site Conditions: Common: Feeling unwell. Uncommon: Unspecific pain, chills.
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