Black Box Warning

CONTRAINDICATED in pregnancy (Category X) — causes fetal harm. Women of childbearing age must use effective contraception.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Atorvastatin.

Other warnings & precautions

Contraindicated in breastfeeding.
Myopathy risk — report unexplained muscle pain, weakness, or tenderness. Risk increases at higher doses and with CYP3A4 inhibitors.
Rhabdomyolysis — rarely fatal. Discontinue immediately if CK markedly elevated or myopathy suspected.
Liver function tests recommended before starting; monitor if symptoms of liver disease develop.
New-onset diabetes — statins associated with small (~10%) increased risk of type 2 diabetes.
Do not use in active liver disease.

Black Box Warning

CONTRAINDICATED in pregnancy (Category X) — causes fetal harm. Women of childbearing age must use effective contraception.

Other warnings & precautions

Contraindicated in breastfeeding.
Myopathy risk — report unexplained muscle pain, weakness, or tenderness. Risk increases at higher doses and with CYP3A4 inhibitors.
Rhabdomyolysis — rarely fatal. Discontinue immediately if CK markedly elevated or myopathy suspected.
Liver function tests recommended before starting; monitor if symptoms of liver disease develop.
New-onset diabetes — statins associated with small (~10%) increased risk of type 2 diabetes.
Do not use in active liver disease.

Atorvastatin Black Box Warning

Black Box Warning

Other warnings & precautions

Atorvastatin Black Box Warning

Black Box Warning

Other warnings & precautions