Drug Safety Information for NUEDEXTA (Dextromethorphan hydrobromide; quinidine sulfate)

Safety-related Labeling Changes for NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE) Rx Drug: FDA Link

Adverse Drug Reactions for NUEDEXTA* (Dextromethorphan hydrobromide; quinidine sulfate)

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 NUEDEXTA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall22
2Fatigue21
3Convulsion20
4Dizziness15
5Asthenia15
6Headache15
7Gait disturbance14
8Pain13
9Drug ineffective13
10Multiple sclerosis relapse13
11Nausea13
12Drug interaction12
13Depression11
14Somnolence11
15Lethargy10
16Muscle spasms9
17Pyrexia9
18Muscular weakness9
19Memory impairment9
20Speech disorder9

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

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

Reason # of FDA Reports
1Affect lability262
2Product used for unknown indication233
3Depression68
4Migraine32
5Multiple sclerosis29
6Anger25
7Pain25
8Amyotrophic lateral sclerosis17
9Bipolar disorder12
10Brain injury12

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


Types of Adverse Events for NUEDEXTA

Total Reports Filed with FDA: 1125


Number of FDA Adverse Event Reports by Patient Age for NUEDEXTA

Total Reports Filed with FDA: 1125*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dextromethorphan hydrobromide; quinidine sulfate (Nuedexta)

Charts are based on 1125 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 NUEDEXTA 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.