Drug information for SPRIX

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SPRAY, METERED; NASAL	15.75MG/SPRAY	Prescription	(Reference Drug)	KETOROLAC TROMETHAMINE	Ketorolac Tromethamine	LUITPOLD	22382 2011-05-03 Review 2011-05-03 Summary Review 2010-05-28 Label 2010-05-21 Letter

Drug Adverse Effects information for SPRIX

Role code	Indications	Reaction	# Reports
PS	NEPHROLITHIASIS	ANAPHYLACTIC REACTION	2
PS	NEPHROLITHIASIS	NASAL DISCOMFORT	2
PS	PAIN	ANAPHYLACTIC REACTION	2
PS	PAIN	NASAL DISCOMFORT	2
PS	RENAL COLIC	ANAPHYLACTOID REACTION	2
PS	RENAL COLIC	CHEST DISCOMFORT	2
PS	RENAL COLIC	DYSPNOEA	2
PS	RENAL COLIC	EAR DISORDER	2
PS	RENAL COLIC	FEAR	2
PS	RENAL COLIC	HYPERHIDROSIS	2
PS	RENAL COLIC	LACRIMATION INCREASED	2
PS	RENAL COLIC	NASAL DISCOMFORT	2
PS	RENAL COLIC	OBSTRUCTION	2
PS	RENAL COLIC	RENAL PAIN	2
PS	RENAL COLIC	THROAT TIGHTNESS	2

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