What the label lists and what reports show
Carbidopa and entacapone and levodopa side effects
Carbidopa and entacapone and levodopa's FDA label: “The most common adverse reactions (incidence 3% higher than placebo incidence) are dyskinesias, hyperkinesia, diarrhea, nausea, abdominal pain, vomiting, dry mouth and urine discoloration ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.” FAERS holds 484 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fall (69 reports).
- Generic listed
Check it at the source: the carbidopa and entacapone and levodopa FDA label on DailyMed (effective March 19, 2026, Sandoz Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence 3% higher than placebo incidence) are dyskinesias, hyperkinesia, diarrhea, nausea, abdominal pain, vomiting, dry mouth and urine discoloration ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
Table 2: Summary of Patients With Adverse Reactions After Start of Trial Drug Administration At Least 1% in Entacapone Group and Greater Than Placebo
| SYSTEM ORGAN CLASS Adverse Reaction | Carbidopa/levodopa plus Entacapone (n=603) % of patients | Carbidopa/levodopa plus Placebo (n=400) % of patients |
|---|---|---|
| Sweating Increased | 2 | 1 |
| Back Pain | 5 | 3 |
| Dyskinesia | 25 | 15 |
| Hyperkinesia | 10 | 5 |
| Hypokinesia | 9 | 8 |
| Dizziness | 8 | 6 |
| Taste Perversion | 1 | 0 |
| Anxiety | 2 | 1 |
| Somnolence | 2 | 0 |
| Agitation | 1 | 0 |
| Nausea | 14 | 8 |
| Diarrhea | 10 | 4 |
| Abdominal Pain | 8 | 4 |
| Constipation | 6 | 4 |
| Vomiting | 4 | 1 |
| Mouth Dry | 3 | 0 |
| Dyspepsia | 2 | 1 |
| Flatulence | 2 | 0 |
| Gastritis | 1 | 0 |
| Gastrointestinal Disorders NOS | 1 | 0 |
| Dyspnea | 3 | 1 |
| Purpura | 2 | 1 |
| Urine Discoloration | 10 | 0 |
| Fatigue | 6 | 4 |
| Asthenia | 2 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling: • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] • Hypotension/Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.2) ] • Dyskinesia [see Warnings and Precautions (5.3) ] • Depression and suicidality [see Warnings and Precautions (5.4) ] • Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.5) ] • Impulse Control and/or Compulsive Behaviors [see Warnings and Precautions (5.6) ] • Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.7) ] • Diarrhea and Colitis [see Warnings and Precautions (5.8) ] • Rhabdomyolysis [see Warnings and Precautions (5.9) ] • Vitamin B6 Deficiency and Seizures [see Warnings and Precautions (5.10) ] • Peptic Ulcer Disease [see Warnings and Precautions (5.13) ] The most common adverse reactions (incidence 3% higher than placebo incidence) are dyskinesias, hyperkinesia, diarrhea, nausea, abdominal pain, vomiting, dry mouth and urine discoloration ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA021485 (Orion Pharma), as published by Sandoz Inc, effective March 19, 2026 (SPL set 9c16c0e0-3b97-486b-b7d5-579f5853e2c5), via openFDA; the full label on DailyMed
What do FAERS reports show?
484 reports list carbidopa and entacapone and levodopa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 88 are coded as a death and 195 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Carbidopa and entacapone and levodopa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions