Drug Safety Information for DOLOPHINE HYDROCHLORIDE (Methadone hydrochloride)
REMS for METHODONE (METHADONE HYDROCHLORIDE) Rx Drug: FDA Link
Shared FDA Risk Evaluation and Mitigation Strategy
Safety-related Labeling Changes for METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for METHADOSE (METHADONE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) Rx Drug: FDA Link
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 DOLOPHINE HYDROCHLORIDE: 1947-08-13
Adverse Drug Reactions for DOLOPHINE HYDROCHLORIDE* (Methadone 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 DOLOPHINE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Toxicity to various agents | 2495 |
| 2 | Drug abuse | 1893 |
| 3 | Completed suicide | 1378 |
| 4 | Cardiac arrest | 1317 |
| 5 | Death | 1317 |
| 6 | Respiratory arrest | 1236 |
| 7 | Drug withdrawal syndrome neonatal | 972 |
| 8 | Overdose | 951 |
| 9 | Nausea* | 931 |
| 10 | Pain | 878 |
| 11 | Cardio-respiratory arrest | 870 |
| 12 | Drug interaction | 743 |
| 13 | Vomiting | 705 |
| 14 | Drug ineffective | 699 |
| 15 | Dyspnoea | 652 |
| 16 | Fatigue* | 633 |
| 17 | Somnolence* | 580 |
| 18 | Headache | 520 |
| 19 | Intentional drug misuse | 514 |
| 20 | Anxiety | 497 |
* This side effect also appears in "Top 10 Side Effects of DOLOPHINE HYDROCHLORIDE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking DOLOPHINE HYDROCHLORIDE
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Product used for unknown indication | 12560 |
| 2 | Pain* | 8275 |
| 3 | Drug dependence* | 2579 |
| 4 | Back pain* | 1586 |
| 5 | Drug withdrawal maintenance therapy | 1273 |
| 6 | Cancer pain | 747 |
| 7 | Pain management* | 553 |
| 8 | Drug abuse | 530 |
| 9 | Dependence* | 398 |
| 10 | Substance abuse | 394 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for DOLOPHINE HYDROCHLORIDE
Total Reports Filed with FDA: 87654
Number of FDA Adverse Event Reports by Patient Age for DOLOPHINE HYDROCHLORIDE
Total Reports Filed with FDA: 87654*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Methadone hydrochloride (Physeptone, Westadone, Methadone, Symoron, Amidine, Metadol, Metadona, Dolophine, Amidone, Methaddict, Diskets, Methadose)
Charts are based on 87654 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 DOLOPHINE HYDROCHLORIDE Reviews and Review Summary .
Historical 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.