Drug Safety Information for LIVALO (Pitavastatin calcium)

FDA Safety-related Labeling Changes for LIVALO (PITAVASTATIN CALCIUM) Rx Drug: Safety Information Link

Adverse Drug Reactions for LIVALO* (Pitavastatin calcium)

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 LIVALO
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Anaemia	185
2	Rash	126
3	Myalgia	119
4	Diarrhoea	105
5	Nausea	95
6	Rhabdomyolysis	89
7	Platelet count decreased	89
8	Pyrexia	88
9	Aspartate aminotransferase increased	88
10	Malaise*	81
11	Alanine aminotransferase increased	79
12	Hepatic function abnormal	78
13	Fatigue	76
14	Decreased appetite	76
15	Dizziness	76
16	Blood creatine phosphokinase increased	68
17	Drug ineffective	68
18	Interstitial lung disease	67
19	Pneumonia	67
20	Headache	66

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

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

	Reason	# of FDA Reports
1	Hyperlipidaemia*	1224
2	Hypercholesterolaemia	807
3	Blood cholesterol increased*	730
4	Product used for unknown indication	699
5	Dyslipidaemia	521
6	Blood cholesterol*	325
7	Blood cholesterol abnormal	258
8	Hypertension	50
9	Lipids abnormal	34
10	Low density lipoprotein increased	29

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

Types of Adverse Events for LIVALO

Total Reports Filed with FDA: 9503

Number of FDA Adverse Event Reports by Patient Age for LIVALO

Total Reports Filed with FDA: 9503*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pitavastatin calcium (Livalo)

Charts are based on 9503 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.