. 2008 Jun 16;29(6):403–413. doi: 10.1016/j.amjoto.2007.11.004

Table 5.

Summary of commonly reported local AEs in clinical trials of INS

Author/year	N	INS Treatment regimen	Treatment duration	Patient population	Adverse events	Active treatment group		Placebo group
Acute rhinosinusitis					Vaginitis	8%		5%
Meltzer et al[77]	407	MF 400 μg BID as adjunct to ACP	21 d	Adolescents and adults (12–73 y)		MF (n = 200)		PBO (n = 207)
					Headache	2%		3%
					Epistaxis	3%		1%
					Nasal burning	2%		1%
					Nasal irritation	2%		2%
					Pharyngitis	2%		3%
Dolor et al [25]	95	FP 400 μg QD as adjunct to cefuroxime axetil and xylometazoline hydrochloride	21 d	Adults (30–55 y)		FP (n=46)		PBO (n=46)
					Headache	6.5%		6.5%
					Epistaxis	6.5%		2.1%
					Vaginal itching/yeast infection	4.3%		2.1%
					Diarrhea	2.1%		4.3%
					Nausea/stomach irritation	4.3%		0%
Nayak et al [62]	967	MF 200, 400 μg BID as adjunct to ACP	21 d	Children and adults (8–78 y)		200 μg (n = 318)	400 μg (n = 324)	PBO (n = 325)
					Epistaxis	5%	6%	6%
					Nasal burning	1%	1%	2%
					Nasal irritation	<1%	2%	0%
					Headache	2%	1%	2%
Meltzer et al [7]	981	MF 200, 400 μg QD	15 d	Adolescents and adults (12–76 y)	Headache	Data not published
Meltzer et al [7]	981	MF 200, 400 μg QD	15 d	Adolescents and adults (12–76 y)	Epistaxis	Data not published

Chronic rhinosinusitis
Lund et al [78]	244	BUD 128 μg BID	20 wk	Adults (19–65 y)		BUD (n = 81)		PBO (n = 86)
					Respiratory infection	13.6%		8.1%
					Headache	6.2%		8.1%
					Blood-tinged secretions	9.9%		3.5%
					Viral infections	6.2%		4.7%
					Pharyngitis	3.37%		4.7%
					Sinusitis	1.2%		5.8%
					Flu-like disorder	4.9%		2.3%
					Pain	4.9%		2.3%
					Rhinitis	4.9%		2.3%
					External ear infection	2.5%		3.5%
Giger et al [61]	112	BDP 400 μg QD or BID (no placebo arm)	12 wk	Adults (19–66 y)		QD arm (n=55)		BID arm (n=57)
					Epistaxis	46.2%		43.8%
					Dryness of nasal mucosa	15.4%		34.4%
					Nasal burning	3.85%		9.38%
					Nasal itching	3.85%		3.13%
					Sinusitis	7.69%		0%
					Pharyngitis	3.85%		0%
					Otitis	3.85%		0%
					Change of taste	3.85%		0%
					Eczema	3.85%		0%
					Nausea and diarrhea	7.69%		3.13%

Sinusitis
Meltzer et al [74]	180	Phase I: FLU	21 d	Adults (mean 36.8 y)		FLU (n = 89)		PBO (n = 86)
		300 μg TID as adjunct to ACP			Headache	67%		58%
					Digestive system	21%		22%
					Diarrhea	16%		16%
					Nausea	8%		8%
					Abdominal pain	4%		1%
					Taste perversion	10%		8%
					Vaginitis	8%		5%
		Phase II: FLU	28 d			FLU (n = 65)		PBO (n = 69)
		300 μg TID			Headache	15%		19%
					Digestive system	3%		12%
					Diarrhea	2%		3%
					Nausea	3%		3%
					Abdominal pain	2%		0%
Barlan et al [75]	89	BUD 100 μg BID as adjunct to ACP	21 d	Children (1–15 y)	No adverse drug reactions observed with BUD (n = 43)
Yilmaz et al [76]	52	BUD 200 μg BID or pseudoephedrine	10 d	Children (6–16 y)	No adverse drug reactions observed with BUD (n = 26)
Yilmaz et al [76]	52	60 μg BID as adjunct to cefaclor	10 d	Children (6–16 y)	No adverse drug reactions observed with BUD (n = 26)

Allergic rhinitis
Grossman et al [67]	250	FP 100 or 200 μg	14 d	Children (4–11 y)		100 μg (n = 84)	200 μg (n = 81)	PBO (n = 85)
		QD			Nasal burning	4%	1%	0%
					Epistaxis	4%	2%	4%
					Headache	0%	1%	2%
Brannan et al [65]	64	BDP 336 μg QD (n=16)	36 d	Men (19–44 y)	^⁎Headache 44%
		or BID (n = 16)			^⁎Pharyngitis 9%
		or BID (n = 16)			^⁎Nasal irritation 2%
Munk et al [72]	140	TAA 220 μg QD	14 d	Adults (20–65 y)		TAA (n = 69)		PBO (n = 70)
Munk et al [72]	140	TAA 220 μg QD	14 d	Adults (20–65 y)	Headache	1.4%		29.%
Graft et al [73]	349	MF 200 μg QD or	MF:	Adolescents
		BDP 168 μg BID	7 d	(12–69 y)		MF (n = 117)	BDP (n = 116)	PBO (n = 116)
			BDP:		Headache	36%	22%	23%
			14 d		Pharyngitis	6%	10%	5%
			and adults		URTI	6%	3%	<1%
			and adults		Dysmenorrhea	6%	0%	8%
Brannan et al [69]	96	MF 50, 100, or	7 or 14 d	Children (3–12 y)		50 μg0 (n = 24)	100 μg (n = 24)	200 μg (n = 24)	PBO (n = 24)
Brannan et al [69]	96	200 μg QD	7 or 14 d	Children (3–12 y)	Headache	4%	8%	13%	13%
Schenkel et al [50]	98	MF 100 μg QD	1 y	Children (3–9 y)		MF (n = 49)		PBO (n = 49)
					Epistaxis	12%		8%
					Nasal irritation	8%		6%
					Headache	0%		2%
					Pharyngitis	0%		2%
					Rhinitis	0%		2%
					Sneezing	0%		2%
					Urticaria	0%		2%
					Conjunctivitis	2%		0%
Skoner et al [51]	100	BDP 168 μg BID	1 y	Children (6–9 y)		BDP (n = 49)		PBO (n = 51)
					Epistaxis	20%		27%
					Nasal burning	8%		14%
					Nasal irritation	6%		8%
					Rhinitis	2%		4%
					Sneezing	0%		10%
					Lacrimation	0%		4%
					Increased appetite	0%		4%
					Coughing	0%		4%
Allen et al [70]	150	FP 200 μg QD	1 y	Children (3.5–9 y)		FP (n = 74)		PBO (n = 76)
					Epistaxis	9%		8%
					Nasal irritation	3%		0%
					Headache	1%		1%
					Gastric upset	0%		1%
					Nasal burning	0%		1%
					Nasal soreness	1%		0%
					Vestibulitis of nose	0%		1%
Kim et al [26]	78	BUD 64 μg QD	6 wk	Children (2–5 y)		BUD (n = 39)		PBO (n = 39)
					Respiratory infection	5.1%		10.3%
					Otitis media	7.7%		5.1%
					Accident and/or injury	10.3%		0%
					Fever	7.7%		2.6%
					Gastroenteritis	5.1%		5.1%
					Headache	2.6%		7.7%
					Insect bite/scratch	2.6%		5.1%
					Parasitosis	5.1%		2.6%
					Rash	2.6%		5.1%
					Coughing	5.1%		0%

URTI indicates upper respiratory tract infection.

^⁎

The incidence of these AEs was similar in active treatment and placebo groups.