Applies to aprepitant: oral capsule, oral powder for suspension. Other dosage forms:

• intravenous emulsion

Serious side effects of Aprepitant

Along with its needed effects, aprepitant 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 immediately if any of the following side effects occur while taking aprepitant:

Less common

• Black or tarry stools
• chills
• cough
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• shortness of breath
• sore throat
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Blistering, peeling, or loosening of the skin
• confusion about identity, place, and time
• diarrhea
• itching or skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• red, irritated eyes
• red skin lesions, often with a purple center
• slow or irregular heartbeat

Other side effects of Aprepitant

Some side effects of aprepitant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• heartburn
• hiccups
• increase in heart rate
• indigestion
• lack or loss of strength
• lightheadedness
• loss of appetite
• nausea
• rapid breathing
• stomach discomfort upset or pain
• sunken eyes
• swelling or inflammation of the mouth
• thirst
• weight loss
• wrinkled skin

Less common

• Burning feeling in the chest or stomach
• hot flashes
• indigestion
• pain or discomfort in the chest, upper stomach, or throat
• tenderness in the stomach area

For Healthcare Professionals

Applies to aprepitant: intravenous emulsion, oral capsule, oral kit, oral powder for reconstitution.

General

The most commonly reported side effects included headache, fatigue, neutropenia, constipation, and pruritus.^[Ref]

Other

Very common (10% or more): Fatigue (up to 15%)

Common (1% to 10%): Asthenia, extremity pain, pyrexia

Uncommon (0.1% to 1%): Malaise

Rare (0.01% to 0.1%): Tinnitus

Frequency not reported: Hypothermia, pain^[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 13%)

Common (1% to 10%): Anemia, hemoglobin decreased, leukopenia, white blood cell count decreased

Uncommon (0.1% to 1%): Febrile neutropenia, thrombocytopenia

Rare (0.01% to 0.1%): Neutrophil count decreased

Frequency not reported: Blood albumin decreased^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 13%)

Common (1% to 10%): Abdominal pain, constipation, dyspepsia, eructation, flatulence, nausea, vomiting

Uncommon (0.1% to 1%): Dry mouth, gastritis, gastroesophageal reflux disease, oral candidiasis

Rare (0.01% to 0.1%): Abdominal distention, duodenal ulcer perforation, feces hard, neutropenic colitis, stomatitis

Frequency not reported: Abdominal pain upper, acid reflux, bowel sounds abnormal, epigastric discomfort, obstipation, stomach discomfort, subileus^[Ref]

Local

Common (1% to 10%): Infusion-site erythema, infusion-site induration, infusion-site pain, infusion-site pruritus, infusion-site thrombophlebitis

Uncommon (0.1% to 1%): injection-site pain, vessel puncture-site pain^[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia, flushing, hypertension, hypotension

Uncommon (0.1% to 1%): Edema peripheral, flushing, hot flush, palpitations

Rare (0.01% to 0.1%): Cardiovascular disorder, chest discomfort, edema

Frequency not reported: Blood pressure decreased, hematoma, operative hemorrhage^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, peripheral neuropathy

Uncommon (0.1% to 1%): Dysgeusia, somnolence

Rare (0.01% to 0.1%): Cognitive disorder, gait disturbance, lethargy

Frequency not reported: Hypoesthesia, sensory disturbance, syncope

Postmarketing reports: Ifosfamide-induced neurotoxicity^[Ref]

Hepatic

Common (1% to 10%): ALT increased, AST increased

Uncommon (0.1% to 1%): Blood alkaline phosphatase increased

Frequency not reported: Blood bilirubin increased/bilirubin increased^[Ref]

Respiratory

Common (1% to 10%): Cough, hiccups

Uncommon (0.1% to 1%): Dyspnea, oropharyngeal pain, pharyngitis

Rare (0.01% to 0.1%): Postnasal drip, sneezing, throat irritation

Frequency not reported: Hypoxia, respiratory depression, wheezing^[Ref]

Metabolic

Common (1% to 10%): Decreased appetite, dehydration

Uncommon (0.1% to 1%): Blood potassium decreased/hypokalemia

Rare (0.01% to 0.1%): Blood sodium decreased/hyponatremia, polydipsia, weight decreased

Frequency not reported: Blood glucose increased/hyperglycemia, hypovolemia, thirst, weight gain^[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Acne, alopecia, hyperhidrosis, rash

Rare (0.01% to 0.1%): Photosensitivity reaction, rash pruritic, seborrhea, skin lesion, Stevens-Johnson syndrome, toxic epidermal necrolysis

Frequency not reported: Oily skin, urticaria^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Anxiety

Rare (0.01% to 0.1%): Abnormal behavior, agitation, behavior changes, disorientation, euphoria/euphoric mood

Frequency not reported: Dream abnormality^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Dysuria, proteinuria

Rare (0.01% to 0.1%): Pollakiuria, red blood cells urine positive, urine output increased

Frequency not reported: Microscopic hematuria, polyuria^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Musculoskeletal pain

Rare (0.01% to 0.1%): Muscular weakness, muscle spasms

Frequency not reported: Dysarthria, muscle cramp, myalgia^[Ref]

Renal

Uncommon (0.1% to 1%): Blood urea increased

Rare (0.01% to 0.1%): Glucose urine present^[Ref]

Immunologic

Rare (0.01% to 0.1%): Candidiasis, staphylococcal infection

Frequency not reported: Postoperative infection, wound dehiscence^[Ref]

Ocular

Rare (0.01% to 0.1%): Conjunctivitis

Frequency not reported: Miosis, visual acuity reduced^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reactions, angioedema, hypersensitivity reactions

Postmarketing reports: Anaphylactic shock, anaphylaxis^[Ref]