Aerospan HFA Side Effects

Generic Name: flunisolide

Note: This page contains information about the side effects of flunisolide. Some of the dosage forms included on this document may not apply to the brand name Aerospan HFA.

Not all side effects for Aerospan HFA may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to flunisolide: inhalation aerosol powder

In addition to its needed effects, some unwanted effects may be caused by flunisolide (the active ingredient contained in Aerospan HFA). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking flunisolide:

More common
  • Body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble with swallowing
  • voice changes
Less common
  • Bladder pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • chills
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • hives
  • itching
  • joint or muscle pain
  • lower back or side pain
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red, irritated eyes
  • skin rash
  • slow heartbeat
  • sore mouth or tongue
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • swelling
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known
  • Creamy white, curd-like patches in the mouth or throat
  • darkening of the skin
  • discouragement
  • fainting
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • loss of strength or energy
  • muscle weakness
  • nausea
  • pain when eating or swallowing
  • trouble concentrating
  • trouble sleeping
  • vomiting

Some of the side effects that can occur with flunisolide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Abdominal or stomach fullness
  • acid or sour stomach
  • appetite changes
  • bad, unusual, or unpleasant (after) taste
  • belching
  • blemishes on the skin
  • burning, dry, or itching eyes
  • change in taste
  • constipation
  • cramps
  • difficulty with moving
  • discharge or excessive tearing
  • dizziness or lightheadedness
  • ear pain
  • fear
  • feeling of constant movement of self or surroundings
  • gas
  • headache, severe and throbbing
  • heartburn
  • heavy bleeding
  • indigestion
  • irritability
  • itching of the vagina or genital area
  • loss of smell or taste
  • muscle aching or cramping
  • muscle stiffness
  • pain during sexual intercourse
  • pain in the neck
  • pimples
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sensation of spinning
  • shakiness
  • skin rash, encrusted, scaly, and oozing
  • stomach discomfort, upset, or pain
  • swollen joints
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble sitting still
  • trouble sleeping
  • upset stomach

For Healthcare Professionals

Applies to flunisolide: compounding powder, inhalation aerosol, inhalation aerosol with adapter

General

Flunisolide (the active ingredient contained in Aerospan HFA) has been generally well tolerated and, due to the nature of its administration, has not been inclined to produce the adverse effects generally associated with the systemic use corticosteroids.[Ref]

Gastrointestinal

Gastrointestinal side effects have included oropharyngeal candidiasis in approximately 3% to 9% of patients treated, as well as nausea and vomiting (25%), diarrhea (10%), and upset stomach (10%). In addition, flunisolide (the active ingredient contained in Aerospan HFA) has produced a bitter taste in most patients.[Ref]

To reduce the incidence of thrush, patients should be instructed to rinse their mouths following the use of flunisolide. Limited data suggest that the incidence of thrush secondary to inhaled corticosteroids may be lower in patients utilizing a spacer device and good inhalation technique.[Ref]

Respiratory

Many patients who experience coughing and wheezing may benefit from pretreatment with an inhaled beta-agonist prior to administration of flunisolide (the active ingredient contained in Aerospan HFA) [Ref]

Respiratory side effects have included dysphonia, sore throat, and cold symptoms. Coughing and wheezing have also been frequently reported, especially in patients whose disease is poorly controlled. Nasal irritation, burning and stinging, congestion, epistaxis, sneezing, and rarely, nasal septal perforations have been reported with intranasal administration. Temporary or permanent loss of the sense of smell and taste have occurred with both oral inhalation and intranasal formulations. Upper respiratory tract infections are also more common in patients receiving flunisolide.[Ref]

Nervous system

Nervous system side effects have generally been limited to headache, which has occurred in up to 25% of patients. Dizziness, nervousness, shakiness, depression, and insomnia have been reported in less than 10% of patients.[Ref]

Endocrine

Endocrine side effects have rarely included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression has been less than that associated with systemic corticosteroids and, generally, has been only of concern when using higher than recommended doses.[Ref]

Immunologic

In 1993, the American Academy of Allergy and Immunology (AAAI) requested the FDA review their decision concerning the relabeling of inhaled corticosteroids with respect to the risk of their use during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.[Ref]

Immunologic side effects have included the danger of infections from immune suppression associated with inhaled corticosteroids. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled corticosteroids.[Ref]

Musculoskeletal

Musculoskeletal side effects have included the potential of reduction in bone density with the long term use of inhaled corticosteroids. This effect may have been dose-related and has been reported with high dosages of orally inhaled beclomethasone and budesonide (>= 800 mcg/day for >= 1 year). Reduced levels of total body calcium have also been demonstrated in patients receiving lower dosages.[Ref]

Ocular

Ocular side effects have included occasional reports of capsular cataracts, especially with long-term use. In addition, one epidemiologic study suggested that prolonged use of high-dose inhaled corticosteroids (>= 1500 mcg of flunisolide (the active ingredient contained in Aerospan HFA) may be associated with increased risk of ocular hypertension and open-angle glaucoma.[Ref]

Dermatologic

Dermatologic side effects have included eczema, acne, rash, and urticaria. Easy bruising has also been associated with flunisolide (the active ingredient contained in Aerospan HFA) use in some patients.[Ref]

References

1. Pakes GE, Brogden RN, Heel RD, Speight TM, Avery GS "Flunisolide: a review of its pharmacological properties and therapeutic efficacy in rhinitis." Drugs 19 (1980): 397-411

2. Turkeltaub PC, Norman PS, Johnson JD, Crepea S "Treatment of seasonal and perennial rhinitis with intranasal flunisolide." Allergy 37 (1982): 303-11

3. "Product Information. Aerobid (flunisolide)." Forest Pharmaceuticals, St. Louis, MO.

4. Brown PH, Greening AP, Crompton GK "Large volume spacer devices and the influence of high dose beclomethasone dipropionate on hypothalamo-pituitary-adrenal axis function." Thorax 48 (1993): 233-8

5. Clayton DE, Kooistra JB, Geller M, Ouellette J, Cohen M, Reed CE, Busse W "Short-term efficacy trial and twenty-four-month follow-up of flunisolide nasal spray in the treatment of perennial rhinitis." J Allergy Clin Immunol 67 (1981): 2-7

6. Silvers WS, Cohen R, D'Alonzo G, Fishken D, Lim JC, Stokes AL, McNally CF "Comparative taste evaluation of aerosolized formulations of triamcinolone acetonide." Clin Ther 15 (1993): 988-93

7. "Product Information. Nasalide (flunisolide)." Syntex Laboratories Inc, Palo Alto, CA.

8. Meltzer EO, Orgel HA, Bush RK, Haltom JR, Metzger WJ, Moss BA, Mitchell DQ, Ballas ZK, Seltzer JM, Shapiro GG, et al "Evaluation of symptom relief acceptability of two formulations of flunisolide nasal spray in patients with perennial allergic rhinitis." Ann Allergy 64 (1990): 536-40

9. Pipkorn U, Geterud A "A comparative trial testing budesonide and flunisolide nasal sprays in patients with seasonal allergic rhinitis." Ann Allergy 52 (1984): 183-6

10. Dickson DJ, Cruickshank JM "Comparison of flunisolide nasal spray and terfenadine tablets in hay fever." Br J Clin Pract 38 (1984): 416-20

11. Greenbaum J, Leznoff A, Schulz J, Mazza J, Tobe A, Miller D "Comparative tolerability of two formulations of Rhinalar (flunisolide) nasal spray in patients with seasonal allergic rhinitis." Ann Allergy 61 (1988): 305-10

12. Robinson DS, Geddes DM "Inhaled corticosteroids: benefits and risks." J Asthma 33 (1996): 5-16

13. Sorkin S, Warren D "Probable adrenal suppression from intranasal beclomethasone." J Fam Pract 22 (1986): 449-50

14. Brown PH, Greening AP, Crompton GK "Hypothalamo-pituitary-adrenal axis suppression in asthmatic adults taking high dose beclomethasone dipropionate." Br J Clin Pract 46 (1992): 102-4

15. Harris DM, Martin LE, Harrison C, Jack D "The effect of oral and inhaled beclomethasone dipropionate on adrenal function." Clin Allergy 3 (1973): 243-8

16. Executive Committee American Academy of Allergy and Immunology "Inhaled corticosteroids and severe viral infections." J Allergy Clin Immunol 92 (1993): 223-8

17. Packe GE, Douglas JG, McDonald AF, Robins SP, Reid DM "Bone density in asthmatic patients taking high dose inhaled beclomethasone diproprionate and intermittent systemic corticosteroids." Thorax 47 (1992): 414-7

18. Hanania NA, Chapman KR, Sturtridge WC, Szalai JP, Kesten S "Dose-related decrease in bone density among asthmatic patients treated with inhaled corticosteroids." J Allergy Clin Immunol 96 (1995): 571-9

19. Garbe E, LeLorier J, Boivin JF, Suissa S "Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma." JAMA 277 (1997): 722-7

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