Rytary Side effects

• Side effects of Rytary in details
• Rytary contraindications
• Rytary reviews

What are the possible side effects of Rytary?

Get emergency medical help if you have signs of an allergic reaction to Rytary: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• worsening of tremors (uncontrolled shaking);

• severe or ongoing vomiting or diarrhea;

• confusion, hallucinations, unusual changes in mood or behavior;

• depression or suicidal thoughts; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Some people taking Rytary have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Common Rytary side effects may include:

• jerky or twisting muscle movements;

• headache, dizziness;

• low blood pressure (feeling light-headed);

• sleep problems, strange dreams;

• dry mouth;

• muscle contractions; or

• nausea, vomiting, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rytary side effects (more detail)

Side effects of Rytary in details

The following serious adverse reactions are discussed below and elsewhere in the labeling:

• Falling asleep during activities of daily living and somnolence
• Withdrawal-emergent hyperpyrexia and confusion
• Cardiovascular ischemic events
• Hallucinations/psychosis
• Impulse control/compulsive behaviors
• Dyskinesia
• Peptic Ulcer Disease
• Glaucoma
• Melanoma

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety population consisted of a total of 978 Parkinson's disease patients who received at least one dose of RYTARY, and had an average duration of exposure of 40 weeks.

Adverse Reactions In Early Parkinson's Disease

In a placebo-controlled clinical study in patients with early Parkinson's disease (Study 1), the most common adverse reactions with RYTARY (in at least 5% of patients and more frequently than in placebo) were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

Table 2 lists adverse reactions occurring in at least 5% of RYTARY-treated patients and at a higher rate than placebo in Study 1.

Table 2: Adverse Reactions in Study 1 in Patients with Early Stage Parkinson's Disease

	Placebo	RYTARY 36.25 mg Carbidopa (Rytary) 145 mg Levodopa (Rytary) TID	RYTARY 61.25 mg Carbidopa (Rytary) 245 mg Levodopa (Rytary) TID	RYTARY 97.5 mg Carbidopa (Rytary) 390 mg Levodopa (Rytary) TID
(N=92) %	(N=87) %	(N=104) %	(N=98) %
Nausea	9	14	19	20
Dizziness	5	9	19	12
Headache	11	7	13	17
Insomnia	3	2	9	6
Abnormal Dreams	0	2	6	5
Dry Mouth	1	3	2	7
Dyskinesia	0	2	4	5
Anxiety	0	2	3	5
Constipation	1	2	6	2
Vomiting	3	2	2	5
Orthostatic
Hypotension	1	1	1	5

Adverse Reactions Leading to Discontinuation in Study 1

In Study 1, 12% of patients discontinued RYTARY early due to adverse reactions; a higher proportion of patients in the 61.25 mg / 245 mg RYTARY-treated group (14%) and in the 97.5 mg / 390 mg RYTARY-treated group (15%) experienced adverse reactions leading to early discontinuation compared to (4%) in the placebo group. The most common adverse reactions resulting in early discontinuation were nausea, dizziness, and vomiting.

Adverse Reactions In Advanced Parkinson's Disease

In an active-controlled clinical study in patients with advanced Parkinson's disease (Study 2), the most common adverse reactions with RYTARY that occurred during dose conversion or maintenance (in at least 5% of patients and more frequently than on oral immediate-release Carbidopa (Rytary)-Levodopa (Rytary)) were nausea and headache.

Table 3 lists adverse reactions occurring in at least 5% of RYTARY-treated patients and at a higher rate than oral immediate-release Carbidopa (Rytary)-Levodopa (Rytary) in Study 2.

Table 3: Adverse Reactions in Study 2 in Patients with Advanced Parkinson's Disease

Period	RYTARY (N=201)	Immediate-Release Carbidopa (Rytary)-Levodopa (Rytary) (N=192)
Dose Convers ion*	Maintenance	Dose Convers ion*	Maintenance
%	%	%	%
Nausea	4	3	6	2
Headache	5	1	3	2
*All patients were converted to RYTARY in the open label Dose Conversion period and then received randomized treatment during maintenance.

Adverse Reactions Leading to Discontinuation in Study 2

In Study 2, 5% of patients discontinued treatment due to adverse reactions during conversion to RYTARY. The common adverse reactions leading to discontinuation during dose conversion were dyskinesia, anxiety, dizziness, and on and off phenomenon.

What is the most important information I should know about Rytary?

• Rytary may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Rytary with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Rytary; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Rytary may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Tell your doctor or dentist that you take Rytary before you receive any medical or dental care, emergency care, or surgery.
• NMS is a possibly fatal syndrome that can be caused by Rytary. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Rytary have reported suddenly falling asleep while performing daily activities (eg, driving, eating, talking). Some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Some of these events have been reported as late as 1 year after Rytary was started. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while using Rytary.
• Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Rytary also increases the risk of melanoma. You may need to have skin exams while you are using Rytary. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.
• Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while taking Rytary. Tell your doctor right away if you notice such effects.
• Diabetes patients - Rytary may cause the results of some tests for urine glucose or urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Do not suddenly stop taking Rytary. Some conditions may become worse when Rytary is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects.
• Gradually increase physical activity as your symptoms improve.
• A dark color (red, brown, or black) may appear in your saliva, urine, or sweat after taking Rytary. This is not harmful.
• The effects of Rytary might start to wear off between doses. Talk with your doctor if Rytary stops working well or if your condition worsens.
• Rytary may affect certain lab test results. Make sure your doctors and lab personnel know you take Rytary.
• Lab tests, including complete blood cell counts and liver function, may be performed while you use Rytary. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Rytary with caution in the ELDERLY; they may be more sensitive to its effects.
• Rytary should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Rytary while you are pregnant. It is not known if Rytary is found in breast milk. If you are or will be breast-feeding while you are taking Rytary, check with your doctor. Discuss any possible risks to your baby.

Rytary contraindications

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Rytary orally disintegrating tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Rytary orally disintegrating tablets. Rytary orally disintegrating tablets may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCI).

Rytary orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

Because Levodopa (Rytary) may activate a malignant melanoma, Rytary orally disintegrating tablets should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

References

1. DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "levodopa: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. DTP/NCI. "carbidopa: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Rytary are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Rytary. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology