Drug Safety Information for ZOHYDRO ER (Hydrocodone bitartrate)

Safety-related Labeling Changes for VICOPROFEN (HYDROCODONE BITARTRATE; IBUPROFEN) Rx Drug: FDA Link


Safety-related Labeling Changes for ZOHYDRO ER (HYDROCODONE BITARTRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for HYSINGLA (HYDROCODONE BITARTRATE) Rx Drug: FDA Link

Required post-approval safety study:

Deferred pediatric study under PREA: Conduct a pharmacokinetic and safety study of an age-appropriate formulation of hydrocodone extended-release in patients from ages 7 to less than 12 years with moderate-to-severe pain requiring around the clock opioid therapy for an extended period of time. Due Date: 2022-03-31

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 ZOHYDRO ER: 2013-10-25

Adverse Drug Reactions for ZOHYDRO ER* (Hydrocodone bitartrate)

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 ZOHYDRO ER
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective98
3Inadequate analgesia53
4Drug effect decreased49
8Feeling abnormal30
11Therapeutic response decreased19
12Breakthrough pain19
19Drug effect increased12

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

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

Reason # of FDA Reports
1Product used for unknown indication600
3Back pain22
4Neck pain16
5Spinal pain7
6Analgesic therapy6
8Procedural pain6
9Crohn's disease6
10Testicular pain5

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

Types of Adverse Events for ZOHYDRO ER

Total Reports Filed with FDA: 946

Number of FDA Adverse Event Reports by Patient Age for ZOHYDRO ER

Total Reports Filed with FDA: 946*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydrocodone bitartrate (Zohydro er, Zohydro, Hysingla)

Charts are based on 946 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.

Click to go back to search results and ZOHYDRO ER Reviews and Review Summary .

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.

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