Drug Safety Information for RYTARY (Carbidopa; levodopa)

Safety-related Labeling Changes for RYTARY (CARBIDOPA; LEVODOPA) Rx Drug: FDA Link

Safety-related Labeling Changes for DUOPA (CARBIDOPA; LEVODOPA) Rx Drug: FDA Link

Adverse Drug Reactions for RYTARY* (Carbidopa; levodopa)

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 RYTARY
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall560
2Drug ineffective527
3Parkinson's disease442
4Tremor411
5Confusional state*385
6Hallucination*383
7Nausea*369
8Dyskinesia366
9Somnolence*359
10Dizziness348
11Asthenia322
12Dyspnoea297
13Drug interaction277
14Fatigue268
15Depression266
16Gait disturbance262
17Insomnia*262
18Anxiety*260
19Pathological gambling236
20Death229

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

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

Reason # of FDA Reports
1Parkinson's disease*9459
2Product used for unknown indication1906
3Restless legs syndrome*726
4Parkinsonism*425
5Tremor178
6Dystonia83
7Extrapyramidal disorder48
8Ill-defined disorder46
9Muscle spasms39
10Dementia32

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


Types of Adverse Events for RYTARY

Total Reports Filed with FDA: 36162


Number of FDA Adverse Event Reports by Patient Age for RYTARY

Total Reports Filed with FDA: 36162*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Carbidopa; levodopa (Duopa, Sinemet cr, Rytary, Carbilev, Parcopa, Sinemet)

Charts are based on 36162 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 RYTARY 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 RYTARY's side effects.