Drug Safety Information for INVANZ (Ertapenem sodium)

Safety-related Labeling Changes for INVANZ (ERTAPENEM SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for INVANZ* (Ertapenem sodium)

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 INVANZ
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Convulsion	275
2	Confusional state	167
3	Hallucination	97
4	Diarrhoea*	96
5	Pyrexia	90
6	Death	77
7	Drug interaction	64
8	Rash	63
9	Pneumonia	61
10	Nausea	59
11	Sepsis	59
12	Drug ineffective	55
13	Asthenia	55
14	Renal failure acute	52
15	Hypotension	51
16	Mental status changes	50
17	Delirium	48
18	Dyspnoea	43
19	Fall	42
20	Agitation	42

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	574
2	Urinary tract infection	477
3	Infection	306
4	Pneumonia	182
5	Osteomyelitis	155
6	Cellulitis	140
7	Bacteraemia	115
8	Sepsis	95
9	Klebsiella infection	78
10	Antibiotic therapy	67

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

Types of Adverse Events for INVANZ

Total Reports Filed with FDA: 7620

Number of FDA Adverse Event Reports by Patient Age for INVANZ

Total Reports Filed with FDA: 7620*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ertapenem sodium (Ertapenem, Ertapenem sodium, Invanz)

Charts are based on 7620 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.