Profilnine SD Side Effects

Generic name: factor ix complex

Note: This document contains side effect information about factor ix complex. Some of the dosage forms listed on this page may not apply to the brand name Profilnine SD.

Some side effects of Profilnine SD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to factor ix complex: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking factor ix complex (the active ingredient contained in Profilnine SD) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using factor IX and call your doctor at once if you have a serious side effect such as:

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• weak or shallow breathing;

• feeling short of breath;

• headache, feeling like you might pass out;

• flushing (warmth, redness, or tingly feeling);

• fast or slow heart rate;

• fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• easy bruising, increased bleeding episodes; or

• bleeding from a wound or where the medicine was injected.

Less serious side effects of factor ix complex may include:

• mild nausea;

• mild stomach pain; or

• mild tingly or jittery feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to factor ix complex: intravenous powder for injection

General

General side effects have included fever and chills.

Cardiovascular

Cardiovascular side effects have included flushing, and changes in pulse rate and blood pressure.

Dermatologic

Dermatologic side effects have included urticaria.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Hematologic

Hematologic side effects have included intravascular coagulation, thrombosis, and emboli.

Nervous system

Nervous system side effects have included headache, somnolence, lethargy, and tingling.

Respiratory

Respiratory side effects have included respiratory distress, chest pain, and cough.

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