Veral Adverse Reactions

The following adverse events reactions have been reported with verapamil from clinical studies, post-marketing surveillance or phase IV clinical trials and are listed as follows by system organ class.
The frequencies are defined as follows: 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), Not known (cannot be estimated from the available data).
The most commonly reported ADRs were headache, dizziness or drowsiness, gastrointestinal disorders (nausea, constipation and abdominal disorders), further bradycardia, tachycardia, palpitations, hypotension, flushing, oedema peripheral, as well as fatigue.
Adverse reactions reported from clinical studies with verapamil and post-marketing surveillance activities: Immune system disorders: Not known: Hypersensitivity.
Metabolism and nutrition disorders: Uncommon: Reduced glucose tolerance. Not known: Hyperkalaemia.
Psychiatric disorders: Common: Nervosity. Rare: Somnolence.
Nervous system disorders: Common: Dizziness or drowsiness, headache, neuropathy. Rare: Paraesthesia, tremor. Not known: Extrapyramidal symptoms, paralysis (tetraparesis), convulsions.
Ear and labyrinth disorders: Rare: Tinnitus. Not known: Vertigo.
Cardiac disorders: Common: Bradycardia, development of cardiac insufficiency or exacerbation of pre-existing cardiac insufficiency, excessive fall in blood pressure and/or orthostatic dysregulation. Uncommon: Palpitations, tachycardia. Not known: AV block (degree I, II, III), cardiac insufficiency, sinus arrest, sinus bradycardia, asystole.
Vascular disorders: Common: Flush, hypotension.
Respiratory, thoracic and mediastinal disorders: Not known: Bronchospasm, dyspnoea.
Gastrointestinal disorders: Common: Constipation, nausea. Uncommon: Abdominal pain. Rare: Vomiting. Not known: Abdominal disorders, ileus, gingival hyperplasia.
Hepatobiliary disorders: Uncommon: Probably allergy-induced hepatitis with reversible increase in liver-specific enzymes.
Skin and subcutaneous tissue disorders: Common: Erythromelalgia. Rare: Hyperhidrosis. Very rare: Photodermatitis. Not known: Angioedema, Stevens-Johnson syndrome, erythema multiforme, alopecia, itching, pruritus, purpura, maculopapular exanthema, urticaria.
Musculoskeletal and connective tissue disorders: Very rare: Exacerbation of myasthenia gravis, of Lambert-Eaton syndrome and of advanced Duchenne muscular dystrophy.
Not known: Arthralgia, myasthenia, myalgia.
Renal and urinary disorders: Not known: Renal insufficiency.
Reproductive system and breast disorders: Not known: Erectile dysfunction, galactorrhoea, gynaecomastia.
General disorders and administration site conditions: Common: Peripheral oedema. Uncommon: Fatigue.
Investigations: Unknown: Prolactin in blood increased.
There have been a single post-marketing report of paralysis (tetraparesis) associated with the combined use of verapamil and colchicine. This may have been caused by colchicine crossing the blood-brain barrier due to CYP3A4 and P-gp inhibition of verapamil. See Interactions.
Note: In patients with a pacemaker, an increase in the pacing and sensing threshold cannot be excluded on verapamil hydrochloride.
In patient with a history of cardiovascular disease, e.g. severe cardiomyopathy, congestive heart failure or recent myocardial infarction, the risk of severe side effect was increased with concomitant administration of intravenous beta-blocker or disopyramide with intravenous verapamil as both substance classes exert a cardiodepressive effect (see Interactions).