Drug Safety Information for HYCODAN (Homatropine methylbromide; hydrocodone bitartrate)

Safety-related Labeling Changes for HYCODAN (HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE) Rx Drug: FDA Link

Adverse Drug Reactions for HYCODAN* (Homatropine methylbromide; 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 HYCODAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea47
2Nausea*43
3Cough40
4Pneumonia39
5Fatigue37
6Vomiting*36
7Pain33
8Diarrhoea32
9Pulmonary embolism29
10Deep vein thrombosis26
11Anxiety26
12Asthenia25
13Dehydration25
14Headache*25
15Anaemia24
16Hypertension22
17Dizziness*22
18Chest pain21
19Pleural effusion20
20Back pain20

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

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

Reason # of FDA Reports
1Cough*544
2Product used for unknown indication226
3Pain57
4Gastrointestinal disorder29
5Bronchitis*16
6Hypertension15
7Abdominal pain9
8Upper-airway cough syndrome6
9Restless legs syndrome6
10Pneumonia6

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


Types of Adverse Events for HYCODAN

Total Reports Filed with FDA: 3356


Number of FDA Adverse Event Reports by Patient Age for HYCODAN

Total Reports Filed with FDA: 3356*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Homatropine methylbromide; hydrocodone bitartrate (Hydromet, Hydropane, Tussigon, Hydrocodone compound, Hycodan)

Charts are based on 3356 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 HYCODAN 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.

Visit   DrugInformer.com more on HYCODAN's side effects.