Applies to terlipressin: intravenous powder for solution.

Serious side effects of Terlipressin

Along with its needed effects, terlipressin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking terlipressin:

More common

• Blue lips, fingernails, or skin
• chest pain or discomfort
• chills
• confusion
• decrease in amount of urine
• difficult or trouble breathing
• fast heartbeat
• fever
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness or fainting
• slow or irregular heartbeat
• swelling of the fingers, hands, feet, or lower legs
• unusual tiredness
• weight gain

Less common

• Constipation
• diarrhea
• headache
• itching skin
• nausea
• numbness and tingling of the face, fingers, or toes
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain or discomfort in the arms, jaw, back, or neck
• pale, bluish-colored, or cold hands or feet
• severe numbness, especially on one side of the face or body
• stomach pain, usually after eating a meal
• sweating
• vomiting
• weak or absent pulses in the legs

Incidence not known

• Blue-green to black skin discoloration
• coma
• decreased urine output
• increased thirst
• muscle pain or cramps
• pain, redness, or sloughing of the skin at the place of injection
• seizures
• sores on the skin, especially on the thighs, breasts, penis, or buttocks
• swelling of the face, ankles, or hands

For Healthcare Professionals

Applies to terlipressin: intravenous powder for injection.

Cardiovascular

Common (1% to 10%): Bradycardia, hypertension, hypotension, ischemia, ischemia-related events, vasoconstriction, pallor, supra-ventricular arrhythmia, ventricular arrhythmia

Uncommon (0.1% to 1%): Atrial fibrillation, ventricular extrasystoles, tachycardia, cardiac failure, myocardial infarction, torsade de pointes, cyanosis, hot flushes, chest pain, fluid overload with pulmonary edema, angina pectoris, peripheral cyanosis

Rare (0.01% to 0.1%): Ventricular fibrillation

Very rare (less than 0.01%): Myocardial ischemia^[Ref]

Ischemia-related events included skin discoloration, cyanosis, ischemia, and intestinal ischemia.^[Ref]

Dermatologic

Common (1% to 10%): Paleness

Uncommon (0.1% to 1%): Skin necrosis unrelated to the site of administration, lymphangitis^[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (19.5%), nausea (16%), diarrhea (13%)

Common (1% to 10%): Transient abdominal cramps

Uncommon (0.1% to 1%): Vomiting, intestinal ischemia^[Ref]

General

-The most common adverse reactions with a frequency of 10% or greater were abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

-The most common adverse reactions that led to treatment discontinuation were respiratory failure, abdominal pain, and intestinal ischemia or obstruction.^[Ref]

Local

Uncommon (0.1% to 1%): Local cutaneous necrosis^[Ref]

Metabolic

Common (1% to 10%): Fluid overload (8.5%)

Uncommon (0.1% to 1%): Hyponatremia

Very rare (less than 0.01%): Hyperglycemia^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Triggering of a convulsive disorder

Very rare (less than 0.01%): Stroke^[Ref]

Other

In a clinical study, 67% of the patients developed acute reduction in serum sodium.^[Ref]

Common (1% to 10%): Sepsis (5.5%)

Uncommon (0.1% to 1%): Uterine hypertonus, uterine ischemia

Frequency not reported: Decreased serum sodium, uterine constriction, decreased uterine blood flow

Postmarketing reports: Gangrene^[Ref]

Renal

Frequency not reported: Decreased serum creatinine^[Ref]

Respiratory

Very common (10% or more): Respiratory failure (15.5%), dyspnea (12.5%)

Common (1% to 10%): Pleural effusion (5.5%)

Uncommon (0.1% to 1%): Respiratory distress, pulmonary edema, pain in the chest, bronchospasm^[Ref]