RiteMED Felodipine Adverse Reactions

Summary of the safety profile: Felodipine can cause flushing, headache, palpitations, dizziness and fatigue. Most of these adverse reactions are dose-dependent and appear at the start of treatment of after a dose increase. Should such adverse reactions occur, they are usually transient and diminish with time.
Dose-dependent ankle swelling can occur in patients treated with felodipine. This results from precapillary vasodilatation and is not related to any generalized fluid retention.
Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis. The enlargement can be avoided or reversed by careful oral hygiene.
List of adverse reactions: The adverse reactions listed as follows have been identified from clinical trials and from post-marketing surveillance.
The following definitions of frequencies are used: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Nervous system disorders: Common: Headache. Uncommon: Dizziness, paresthesia.
Cardiac disorders: Uncommon: Tachycardia, palpitations.
Vascular disorders: Common: Flush. Uncommon: Hypotension. Rare: Syncope.
Gastrointestinal disorders: Uncommon: Nausea, abdominal pain. Rare: Vomiting. Very rare: Gingival hyperplasia, gingivitis.
Hepatobiliary disorders: Very rare: Increased liver enzymes.
Skin and subcutaneous tissue disorders: Uncommon: Rash, pruritus. Rare: Urticaria. Very rare: Photosensitivity reactions, leucocytoclastic vasculitis.
Musculoskeletal and connective tissue disorders: Rare: Arthralgia, myalgia.
Renal and urinary disorders: Very rare: Pollakiuria.
Reproductive system and breast disorders: Rare: Impotence/sexual dysfunction.
General disorders and administration site conditions: Very common: Peripheral oedema. Uncommon: Fatigue. Very rare: Hypersensitivity reactions e.g. angioedema, fever.