No black box warning on record for Amlodipine

As of the latest FDA labeling reviewed, Amlodipine (amlodipine besylate) does not carry a black box warning. Standard warnings and precautions still apply — see the full Amlodipine medicine page for the complete safety profile.

Other warnings & precautions

Increased Angina/MI Risk: In patients with severe obstructive CAD, worsening angina and acute MI have been reported when initiating or increasing dose. Monitor carefully.
Hypotension: Can cause symptomatic hypotension, especially in patients with severe aortic stenosis.
Peripheral Edema: The most common side effect. Edema is dose-related and results from arteriolar vasodilation and increased capillary pressure. Not related to cardiac failure.
Gingival Hyperplasia: Can occur with long-term use. Good oral hygiene may help reduce risk.

No black box warning on record for Amlodipine

Other warnings & precautions

Increased Angina/MI Risk: In patients with severe obstructive CAD, worsening angina and acute MI have been reported when initiating or increasing dose. Monitor carefully.
Hypotension: Can cause symptomatic hypotension, especially in patients with severe aortic stenosis.
Peripheral Edema: The most common side effect. Edema is dose-related and results from arteriolar vasodilation and increased capillary pressure. Not related to cardiac failure.
Gingival Hyperplasia: Can occur with long-term use. Good oral hygiene may help reduce risk.

Amlodipine Black Box Warning

No black box warning on record for Amlodipine

Other warnings & precautions

Amlodipine Black Box Warning

No black box warning on record for Amlodipine

Other warnings & precautions