FDA Adverse Events Summary for TRAMADOL HYDROCHLORIDE* (Tramadol hydrochloride)
(based on 289479 reports filed with the FDA between 2004 and June 2015)
These charts and graphs provide data on adverse effects and events attributed to TRAMADOL HYDROCHLORIDE. They are based on FDA Adverse Event reports received through the FDA Adverse Event Reporting System (FAERS) program.
Adverse Event Reports are submitted 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). 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.
Top 20 Adverse Effects Associated with TRAMADOL HYDROCHLORIDE
(reported in FDA Medwatch Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Nausea* | 3941 |
| 2 | Pain | 3569 |
| 3 | Drug ineffective | 3055 |
| 4 | Vomiting | 2907 |
| 5 | Headache* | 2875 |
| 6 | Fatigue | 2792 |
| 7 | Dyspnoea | 2763 |
| 8 | Dizziness* | 2502 |
| 9 | Diarrhoea | 2392 |
| 10 | Fall | 2216 |
| 11 | Arthralgia | 2145 |
| 12 | Asthenia | 2028 |
| 13 | Toxicity to various agents | 1960 |
| 14 | Drug interaction | 1944 |
| 15 | Pain in extremity | 1857 |
| 16 | Malaise | 1769 |
| 17 | Anxiety* | 1761 |
| 18 | Depression | 1750 |
| 19 | Confusional state | 1714 |
| 20 | Pyrexia | 1705 |
* This side effect also appears in "Top 10 Side Effects of TRAMADOL HYDROCHLORIDE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking TRAMADOL HYDROCHLORIDE
(associated with FDA Medwatch Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Product used for unknown indication | 43223 |
| 2 | Pain* | 40143 |
| 3 | Back pain* | 7082 |
| 4 | Analgesic therapy | 3633 |
| 5 | Arthralgia | 3291 |
| 6 | Arthritis* | 1783 |
| 7 | Rheumatoid arthritis* | 1782 |
| 8 | Fibromyalgia* | 1739 |
| 9 | Headache | 1352 |
| 10 | Osteoarthritis | 1316 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for TRAMADOL HYDROCHLORIDE
Total Reports Filed with FDA: 289479
- Male
- Female
- Unknown
Number of FDA Adverse Event Reports by Patient Age for TRAMADOL HYDROCHLORIDE
Total Reports Filed with FDA: 289479*
Note: * Reports include 45,729 reports of unknown age.
