Carbidopa, levodopa and entacapone

What Carbidopa, levodopa and entacapone is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. …

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Carbidopa, Levodopa, and Entacapone, Sandoz Inc; it covers 6 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 5 FDA labels for this medicine have a boxed warning.

Carbidopa, levodopa and entacapone side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The 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 …

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. This is part of the section. Read the full label on DailyMed →

Carbidopa, levodopa and entacapone drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

• Drugs metabolized by COMT: use with caution (5.11, 7.2)
• Anti-hypertensive agents: dose adjustment may be required (7.3)
• Tricyclic antidepressants: risk of hypertension and dyskinesia reported during concomitant use with carbidopa/levodopa (7.4)
• Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of carbidopa, levodopa and entacapone tablets (7.5, 7.6, 7.7, 7.8, 7.9)
• Drugs that interfere with biliary excretion …

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. This is part of the section. Read the full label on DailyMed →

Carbidopa, levodopa and entacapone dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response.

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• Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. (2.1)
• The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient (2.2)
• Individual tablets should not be split or fractionated. Administer only one tablet at each dosing interval (2.6) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including carbidopa, levodopa and entacapone tablets, periodically during treatment, and as clinically indicated [see Warnings and Precautions (5.10)]. If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with carbidopa, levodopa and entacapone tablets while supplementing vitamin B6. 2.2 Dosing Information The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient. Clinical experience with daily doses above 1,600 mg of entacapone is limited. The maximum recommended daily dose of carbidopa, levodopa and entacapone tablets depends on the strength used. The maximum number of tablets to be used in a 24-hour period is less with the highest strength of carbidopa, levodopa and entacapone tablets than with lower strengths (see Table 1). Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 mg per day to 100 mg per day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. Table 1: Maximum Recommended Dose of Carbidopa, Levodopa and Entacapone Tablets in a 24-hour Period Carbidopa, Levodopa and Entacapone Tablets Dosage Strength Maximum Number of Tablets in a 24-hour Period 12.5 mg per 50 mg per 200 mg 8 18.75 mg per 75 mg per 200 mg 25 mg per 100 mg per 200 mg 31.25 mg per 125 mg per 200 mg 37.5 mg per 150 mg per 200 mg 50 mg per 200 mg per 200 mg 6 2.3 Converting Patients from Carbidopa, Levodopa, and Entacapone to Carbidopa, Levodopa and Entacapone tablets Patients currently treated with entacapone 200 mg with each dose of non-extended release carbidopa/levodopa tablet, can switch to the corresponding strength of carbidopa, levodopa and entacapone tablets containing the same amounts of levodopa and carbidopa.

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. This is part of the section. Read the full label on DailyMed →

Carbidopa, levodopa and entacapone in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary There are no adequate data on the developmental risk associated with the use of carbidopa, levodopa and entacapone tablets in pregnant women. In animals, administration of carbidopa-levodopa or entacapone during pregnancy was associated with developmental toxicity, including increased incidences of fetal malformations (see Data). The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.

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In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal data In nonclinical studies in which carbidopa-levodopa was administered to pregnant animals, increased incidences of visceral and skeletal malformations were observed in rabbits at all doses and ratios of carbidopa-levodopa tested, which ranged from 10 times (carbidopa)-5 times (levodopa) to 20 times (carbidopa)-10 times (levodopa) the maximum recommended human dose (MRHD) of 1,600 mg/day. In rats, there was a decrease in the number of live pups delivered by dams receiving approximately two times (carbidopa)-five times (levodopa) the MRHD throughout organogenesis. No effects on malformation frequencies were observed in mice receiving up to 20 times the MRHD of carbidopa-levodopa. In embryo-fetal development studies of entacapone, pregnant animals received doses of up to 1,000 mg/kg/day (rats) or 300 mg/kg/day (rabbits) throughout organogenesis. Increased incidences of fetal variations were evident in litters from rats treated with the highest dose, in the absence of overt signs of maternal toxicity. The maternal plasma entacapone exposure (AUC) associated with this dose was approximately 34 times that in humans at the MRHD. Increased frequencies of abortions and late/total resorptions and decreased fetal weights were observed in the litters of rabbits treated with maternally toxic doses of 100 mg/kg/day (plasma AUCs less than that in humans at the MRHD) or greater. There were no increases in malformation rates in these studies. When entacapone was administered to female rats prior to mating and during early gestation, an increased incidence of fetal eye anomalies (macrophthalmia, microphthalmia, anophthalmia) was observed in the litters of dams treated with doses of 160 mg/kg/day (plasma AUCs seven times that in humans at the MRHD) or greater, in the absence of maternal toxicity. Administration of up to 700 mg/kg/day (plasma AUCs 28 times that in humans at the MRHD) to rats during the latter part of gestation and throughout lactation produced no evidence of developmental impairment in the offspring.

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. Read the full label on DailyMed →

When Carbidopa, levodopa and entacapone should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Carbidopa, levodopa and entacapone tablets are contraindicated in patients:

• Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). These nonselective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa, levodopa and entacapone tablets.
• With narrow-angle glaucoma.
• Concomitant use of nonselective monoamine oxidase (MAO) inhibitors (4)
• Narrow-angle glaucoma (4)

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. Read the full label on DailyMed →

Carbidopa, levodopa and entacapone overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Signs and Symptoms of Overdosage There are very few cases of overdose with levodopa reported in the published literature. Based on the available information, the acute symptoms of levodopa and dopa decarboxylase inhibitor overdose can be expected to arise from dopaminergic overstimulation.

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Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g., hypotension, tachycardia) and more severe psychiatric problems at higher doses. An isolated report of rhabdomyolysis and another of transient renal insufficiency suggest that levodopa overdose may give rise to systemic complications, secondary to dopaminergic overstimulation. COMT inhibition by entacapone treatment is dose-dependent. A massive overdose of entacapone may theoretically produce a 100% inhibition of the COMT enzyme in people, thereby preventing the O-methylation of endogenous and exogenous catechols. In clinical trials, the highest single dose of entacapone administered to humans was 800 mg, resulting in a plasma concentration of 14.1 mcg per mL. The highest daily dose given to humans was 2,400 mg, administered in one study as 400 mg six times daily with carbidopa/levodopa for 14 days in 15 Parkinson's disease patients, and in another study as 800 mg three times daily for 7 days in 8 healthy volunteers. At this daily dose, the peak plasma concentrations of entacapone averaged 2.0 mcg per mL (at 45 min, compared to 1.0 mcg per mL and 1.2 mcg per mL with 200 mg entacapone at 45 min.). Abdominal pain and loose stools were the most commonly observed adverse events during this study. Daily doses as high as 2,000 mg entacapone have been administered as 200 mg 10 times daily with carbidopa/levodopa or benserazide/levodopa for at least 1 year in 10 patients, for at least 2 years in 8 patients and for at least 3 years in 7 patients. Overall, however, clinical experience with daily doses above 1,600 mg is limited. 10.2 Management of Overdosage Hospitalization is advised, and general supportive measures should be employed, along with immediate gastric lavage and repeated doses of charcoal over time. This may hasten the elimination of entacapone in particular, by decreasing its absorption and reabsorption from the GI tract. Intravenous fluids should be administered judiciously and an adequate airway maintained. Respiratory, circulatory and renal function should be monitored and appropriate supportive measures employed. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs, increasing the risk of drug interactions (especially catechol-structured drugs) should be taken into consideration. To date, no experience has been reported with dialysis; hence, its value in overdosage is not known. Hemodialysis or hemoperfusion is unlikely to reduce entacapone levels due to its high binding to plasma proteins.

— FDA label: Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026. This is part of the section. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• Carbidopa and levodopaCrexont, Rytary · 119 products
• Entacapone14 products
• CarbidopaLodosyn · 9 products
• LevodopaInbrija · 2 products

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Sandoz Inc6 products
• Rising Pharma Holdings, Inc.6 products
• Alembic Pharmaceuticals Inc.6 products
• Macleods Pharmaceuticals Limited6 products
• Alembic Pharmaceuticals Limited6 products

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (3)

• ANDA213212Rising · January 25, 2022
• ANDA214495Macleods Pharms · April 15, 2025
• ANDA218535Alembic · February 5, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. October 7, 2025 · Class II · Ongoing · D-0029-2026

   Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

   Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylar — Rising Pharma Holding, Inc.

Official identifiers

Next steps

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• Parkinson's diseaseCondition named on the label: hospitals that treat it
• Sandoz IncMaker or distributor
• Rising Pharma Holdings, Inc.Maker or distributor
• Alembic Pharmaceuticals Inc.Maker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Carbidopa, Levodopa, and Entacapone, Sandoz Inc, effective March 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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