Drug Safety Information for EXALGO (Hydromorphone hydrochloride)

REMS for Hydromorphone Hydrochloride (HYDROMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for DILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for DILAUDID (HYDROMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for EXALGO (HYDROMORPHONE HYDROCHLORIDE) Rx Drug: FDA Link

Required post-approval safety study:

A prospective, observational study designed to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid analgesics. This study must address at a minimum the following specific objectives: a. Estimate the incidence of misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain. Examine the effect of product/formulation, dose and duration of opioid use, prescriber specialty, indication, and other clinical factors (e.g., concomitant psychotropic medications, personal or family history of substance abuse, history of psychiatric illness) on the risk of misuse, abuse, and addiction. b. Evaluate and quantify other risk factors for misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain, including but not limited to the following: demographic factors, psychosocial/behavioral factors, medical factors, and genetic factors. Identify confounders and effect modifiers of individual risk factor/outcome relationships. Due Date: 2020-03-31

Original FDA Drug Approval Date for EXALGO: 2010-03-01

Adverse Drug Reactions for EXALGO* (Hydromorphone hydrochloride)

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 EXALGO
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pain	1911
2	Nausea*	1829
3	Vomiting*	1282
4	Dyspnoea	1053
5	Fatigue	1029
6	Drug ineffective*	961
7	Death	945
8	Diarrhoea	936
9	Abdominal pain	792
10	Back pain	772
11	Headache*	761
12	Pneumonia	748
13	Pyrexia	743
14	Asthenia	733
15	Anxiety	713
16	Fall	665
17	Dizziness*	643
18	Dehydration	625
19	Hypotension	614
20	Toxicity to various agents	596

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

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

	Reason	# of FDA Reports
1	Pain*	16475
2	Product used for unknown indication	13024
3	Back pain*	1430
4	Breakthrough pain	1310
5	Procedural pain	702
6	Analgesic therapy	628
7	Cancer pain	619
8	Pain management	575
9	Abdominal pain	571
10	Headache	319

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

Types of Adverse Events for EXALGO

Total Reports Filed with FDA: 111846

Number of FDA Adverse Event Reports by Patient Age for EXALGO

Total Reports Filed with FDA: 111846*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydromorphone hydrochloride (Hydromorphon, Hydromorphone hcl, Hidromorfona, Hydromorphone, Dilaudid , Dilaudid hp, Dihydromorphinone, Dilaudid-hp, Exalgo, Dilaudid, Palladone)

Charts are based on 111846 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.