Drug Safety Information for LORABID (Loracarbef)

Adverse Drug Reactions for LORABID* (Loracarbef)

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 LORABID
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Insomnia	22
2	Blood pressure increased	21
3	Dizziness	21
4	Nausea	20
5	Fall	20
6	Asthenia	20
7	Pain in extremity	19
8	Pain	19
9	Depression	18
10	Pneumonia	17
11	Drug ineffective	16
12	Dyspnoea	16
13	Somnolence	15
14	Malaise	13
15	Confusional state	13
16	Muscle spasms	12
17	Drug hypersensitivity	12
18	Fatigue	12
19	Decreased appetite	12
20	Headache	12

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

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

	Reason	# of FDA Reports
1	Insomnia	313
2	Sleep disorder	171
3	Depression	101
4	Product used for unknown indication	90
5	Infection	47
6	Anxiety	41
7	Sleep disorder therapy	32
8	Panic disorder	28
9	Nervous system disorder	28
10	Cyst	26

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

Types of Adverse Events for LORABID

Total Reports Filed with FDA: 1812

Number of FDA Adverse Event Reports by Patient Age for LORABID

Total Reports Filed with FDA: 1812*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Loracarbef (Lorax, Lorafem, Lorabid)

Charts are based on 1812 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.