Aliskiren/valsartan

1-10%

Cough (1.1%)

Diarrhea (2.3%)

Rash (1%)

Dizziness (1.4%)

Fatigue (2.6%)

Hyperkalemia (4%)

Hypotension (5.5%)

Nasopharyngitis (2.6%)

Upper RTI (1.4%)

UTI (1.4%)

Vertigo (1.1%)

<1%

Angioedema

Gout

Headache

Renal stones

Postmarketing Reports

Peripheral edema

Increased serum creatinine

Stevens Johnson syndrome

Toxic epidermal necrolysis

Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)

Lactation: discontinue drug or do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Aliskiren & Valsartan may be found in some form under the following brand names:

• Valturna

Aliskiren & Valsartan is part of the drug class:

• Angiotensin II antagonists, other combinations

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if aliskiren/valsartan is excreted in human milk or if it will harm your nursing baby.

• Store aliskiren/valsartan tablets at room temperature between 59°F-86°F (15°C-30°C).
• Keep aliskiren/valsartan in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.
• Keep aliskiren/valsartan and all medicines out of the reach of children.