Drug Safety Information for HYDROCODONE BITARTRATE AND ACETAMINOPHEN (Acetaminophen; hydrocodone bitartrate)

REMS for HYDROCODONE (ACETAMINOPHEN; HYDROCODONE BITARTRATE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Adverse Drug Reactions for HYDROCODONE BITARTRATE AND ACETAMINOPHEN* (Acetaminophen; 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain6187
2Nausea*5702
3Drug ineffective4122
4Fatigue3962
5Dyspnoea3933
6Vomiting*3693
7Headache*3616
8Anxiety3492
9Diarrhoea3099
10Depression3075
11Dizziness*3074
12Asthenia2855
13Back pain2759
14Arthralgia2742
15Pain in extremity2705
16Fall2687
17Completed suicide2591
18Chest pain2526
19Abdominal pain2389
20Insomnia*2319

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

Top 10 Reasons for Taking HYDROCODONE BITARTRATE AND ACETAMINOPHEN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Pain*58806
2Product used for unknown indication34646
3Back pain*6700
4Breakthrough pain3953
5Arthralgia3103
6Rheumatoid arthritis1395
7Arthritis1289
8Fibromyalgia*1275
9Headache1173
10Analgesic therapy1041

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


Types of Adverse Events for HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Total Reports Filed with FDA: 395994


Number of FDA Adverse Event Reports by Patient Age for HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Total Reports Filed with FDA: 395994*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acetaminophen; hydrocodone bitartrate (Anexsia 7.5/325, Maxidone, Hycet, Anexsia 5/325, Co-gesic, Tycolet, Anexsia 7.5/650, Bancap hc, Duradyne dhc, Xodol, Zolvit, Norco, Vicodin, Lorcet-hd, Lorcet 10/650, Zamicet, Norcet, Lorcet, Hydrocodone bit/apap, Vicodin es, Lortab 5/325, Lorcet hd, Lortab 10/325, Lortab 7.5/325, Hy-phen, Stagesic, Lorcet plus, Anexsia, Lortab, Zydone, Allay, Vicodin hp)

Charts are based on 395994 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 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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