Drug Safety Information for ULTRAM ER (Tramadol hydrochloride)

REMS for TRAMADOL (TRAMADOL HYDROCHLORIDE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for ULTRAM (TRAMADOL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ULTRAM ER (TRAMADOL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for CONZIP (TRAMADOL HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ULTRAM ER* (Tramadol 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 ULTRAM ER
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*3941
2Pain3569
3Drug ineffective3055
4Vomiting2907
5Headache*2875
6Fatigue2792
7Dyspnoea2763
8Dizziness*2502
9Diarrhoea2392
10Fall2216
11Arthralgia2145
12Asthenia2028
13Toxicity to various agents1960
14Drug interaction1944
15Pain in extremity1857
16Malaise1769
17Anxiety*1761
18Depression1750
19Confusional state1714
20Pyrexia1705

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

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

Reason # of FDA Reports
1Product used for unknown indication43223
2Pain*40143
3Back pain*7082
4Analgesic therapy3633
5Arthralgia3291
6Arthritis*1783
7Rheumatoid arthritis*1782
8Fibromyalgia*1739
9Headache1352
10Osteoarthritis1316

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


Types of Adverse Events for ULTRAM ER

Total Reports Filed with FDA: 289479


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

Total Reports Filed with FDA: 289479*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tramadol hydrochloride (Topalgic, Tramadol ratiopharm, Tramadol hcl, Tramadol, Tramadin, Tradol, Tramagit, Zytram, Biodalgic, Tradonal, Tramadura, Zydol, Conzip, Rybix odt, Tramal, Tramadol er, Zamudol, Ultram er, Tramundin, Tramadoc, Tramadolor, Rybix, Amadol, Zamadol, Contramal, Tramagetic, Zydol sr, Takadol, Prontofort, Tramadol normon, Tramabeta, Tramake, Tralgiol, Adolonta, Ryzolt, Nobligan, Ultram)

Charts are based on 289479 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 ULTRAM 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.

Visit   DrugInformer.com more on ULTRAM ER's side effects.