Acute oral toxicity (LD50): 37 mg/kg (mouse) MSDS.

Overdose

An overdose of amlodipine could result in a high degree of peripheral vasodilatation with a possibility of reflex tachycardia. Significant and prolonged hypotension leading to shock and fatal outcomes have been reported ^{FDA label}.

Carcinogenesis, mutagenesis, impairment of fertility

Rats and mice treated with amlodipine maleate in the diet on a long-term basis for up to 2 years demonstrated no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was comparable to the maximum recommended human dose of 10 mg amlodipine per day. For the rat, the highest dose was measured to be about twice the maximum recommended human dose ^{FDA label}.

Mutagenicity studies using amlodipine maleate showed no drug-related gene or chromosomal effects ^{FDA label}.

There was no impact on the fertility of rats given oral amlodipine maleate (males for 64 days and females for 14 days before mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose) ^{FDA label}.

Use in pregnancy

The safety of amlodipine in human pregnancy or lactation has not been proven. Amlodipine is therefore considered a pregnancy category C drug ^F3757.
Use amlodipine only if the potential benefit justifies the potential risk ^{FDA label}.

Use in nursing

Discontinue when administering amlodipine ^{FDA label}.