AEROBID SIDE EFFECTS

  • Generic Name: flunisolide inhaler
  • Brand Name: Aerobid, Aerobid M
Last updated on MDtodate: 10/04/2022

SIDE EFFECTS

Adverse events reported in controlled clinical trials and long-term open studies in 514 patients treated with AEROBID (flunisolide) are described below. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer and 122 for 2 years or longer.

Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered. This is a well-known effect of steroid withdrawal.

Incidence 10% or greater:

  • Gastrointestinal: diarrhea (10%), nausea and/or vomiting (25%), upset stomach (10%)
  • General: flu (10%)
  • Mouth and Throat: sore throat (20%)
  • Nervous System: headache (25%)
  • Respiratory: cold symptoms (15%), nasal congestion (15%), upper respiratory infection (25%)
  • Special Senses: unpleasant taste (10%)

Incidence 3-9%

  • Cardiovascular: palpitations
  • Gastrointestinal: abdominal pain, heartburn
  • General: chest pain, decreased appetite, edema, fever
  • Mouth and Throat: Candida infection
  • Nervous System: dizziness, irritability, nervousness, shakiness
  • Reproductive: menstrual disturbances
  • Respiratory: chest congestion, cough* hoarseness, rhinitis, runny nose, sinus congestion sinus drainage, sinus infection, sinusitis, sneezing, sputum, wheezing*
  • Skin: eczema, itching (pruritus), rash
  • Special Senses: ear infection, loss of smell or taste

 

Incidence 1-3%

  • General: chills, increased appetite and weight gain, malaise, peripheral edema, sweating, weakness
  • Cardiovascular: hypertension, tachycardia
  • Gastrointestinal: constipation, dyspepsia, gas
  • Hemic/Lymph: capillary fragility, enlarged lymph nodes
  • Mouth and Throat: dry throat, glossitis, mouth irritation, pharyngitis, phlegm, throat irritation
  • Nervous System: anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity insomnia, moodiness, numbness, vertigo
  • Respiratory: bronchitis, chest tightness* dyspnea, epistaxis, head stuffiness, laryngitis, nasal irritation, pleurisy, pneumonia, sinus discomfort
  • Skin: acne, hives or urticaria
  • Special Senses: blurred vision, earache, eye discomfort, eye infection

Incidence less than 1%, judged by investigators as possibly or probably drug related:

abdominal fullness, shortness of breath.

*The incidences as shown of cough, wheezing, and chest tightness were judged by investigators to be possibly or probably drug related. In placebo-controlled trials, the overall incidences of these adverse events (regardless of investigators’judgement of drug relationship) were similar for drug and placebo-treated groups. They may be related to the vehicle or delivery system.

 

SRC: NLM .