Drug Safety Information for METHADOSE (Methadone hydrochloride)

REMS for METHODONE (METHADONE HYDROCHLORIDE) Rx Drug: Safety Information Link

Shared FDA Risk Evaluation and Mitigation Strategy

FDA Safety-related Labeling Changes for METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for METHADOSE (METHADONE HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for METHADOSE* (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 METHADOSE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Toxicity to various agents2495
2Drug abuse1893
3Completed suicide1378
4Cardiac arrest1317
5Death1317
6Respiratory arrest1236
7Drug withdrawal syndrome neonatal972
8Overdose951
9Nausea*931
10Pain878
11Cardio-respiratory arrest870
12Drug interaction743
13Vomiting705
14Drug ineffective699
15Dyspnoea652
16Fatigue*633
17Somnolence*580
18Headache520
19Intentional drug misuse514
20Anxiety497

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

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

Reason # of FDA Reports
1Product used for unknown indication12560
2Pain*8275
3Drug dependence*2579
4Back pain*1586
5Drug withdrawal maintenance therapy1273
6Cancer pain747
7Pain management*553
8Drug abuse530
9Dependence*398
10Substance abuse394

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


Types of Adverse Events for METHADOSE

Total Reports Filed with FDA: 87654


Number of FDA Adverse Event Reports by Patient Age for METHADOSE

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 METHADOSE 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.