Drug Safety Information for LASTACAFT (Alcaftadine)

FDA Safety-related Labeling Changes for LASTACAFT (ALCAFTADINE) Rx Drug: Safety Information Link

Adverse Drug Reactions for LASTACAFT* (Alcaftadine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LASTACAFT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Ocular hyperaemia	165
2	Eye irritation	93
3	Eye pain	57
4	Eye swelling	51
5	Eye pruritus	51
6	Scleral hyperaemia	35
7	Eyelid oedema	33
8	Hypersensitivity	32
9	Lacrimation increased	26
10	Erythema of eyelid	23
11	Headache	23
12	Eye discharge	22
13	Drug ineffective	20
14	Conjunctivitis	19
15	Erythema	19
16	Drug hypersensitivity	18
17	Vision blurred	17
18	Somnolence	15
19	Off label use	15
20	Fatigue	13

* This side effect also appears in "Top 10 Side Effects of LASTACAFT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LASTACAFT
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Product used for unknown indication	328
2	Hypersensitivity	191
3	Eye allergy	169
4	Conjunctivitis allergic	135
5	Eye pruritus	98
6	Seasonal allergy	70
7	Dry eye	64
8	Lacrimation increased	39
9	Multiple allergies	19
10	Conjunctivitis infective	16

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for LASTACAFT

Total Reports Filed with FDA: 1301

Number of FDA Adverse Event Reports by Patient Age for LASTACAFT

Total Reports Filed with FDA: 1301*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Alcaftadine (Lastacaft)

Charts are based on 1301 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.