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Sinemet CR

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Sinemet CR

Sinemet CR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sinemet CR (carbidopa-levodopa) Sustained-Release Tablets is a dopamine and antiparkinsonism drug used to treat Parkinson's disease. It is available in generic form. Common side effects of Sinemet CR include dizziness, nausea, vomiting, sleeplessness, and headache.

Talk to your doctor about your individualized dosage recommendation of Sinemet CR. Tetrabenazine, isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, and tranylcypromine may interact with Sinemet CR. Tell your doctor all medications you take. Do not drive, use machinery, or do other activity requiring full alertness after using Sinemet CR. Avoid alcohol consumption while taking Sinemet CR. If you are pregnant only use Sinemet CR if clearly needed. Talk to your doctor before taking Sinemet CR if you are breastfeeding.

Our Sinemet CR (carbidopa-levodopa) Sustained-Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sinemet CR in Detail - Patient Information: Side Effects

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.

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

Call your doctor at once if you have any of these serious side effects:

  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • worsening of tremors (uncontrolled shaking);
  • high fever, stiff muscles, sweating, fast or uneven heartbeats, rapid breathing, feeling like you might pass out;
  • seizure (convulsions);
  • painful or difficult urination;
  • severe nausea, vomiting, or diarrhea;
  • uneven heart rate or fluttering in your chest;
  • confusion, hallucinations, anxiety, agitation, depressed mood, thoughts of suicide or hurting yourself;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder.

Less serious side effects may include:

  • mild nausea, dry mouth, loss of appetite, heartburn, diarrhea, constipation;
  • headache, dizziness, drowsiness, blurred vision;
  • sneezing, stuffy nose, cough, or other cold symptoms;
  • sleep problems (insomnia), strange dreams;
  • muscle pain, numbness or tingly feeling; or
  • skin rash or itching.

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.

Read the entire detailed patient monograph for Sinemet CR (Carbidopa-Levodopa Sustained Release) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sinemet CR Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, nausea, vomiting, trouble sleeping, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause your urine, sweat or saliva to turn red, brown, or black. This is harmless, but your clothes may become discolored.

Some people using this medication have reported falling asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy.

Tell your doctor immediately if any of these unlikely but serious side effects occur: greatly increased eye blinking/twitching, irregular heartbeat, fainting, mental/mood changes (e.g., confusion, depression, hallucinations, thoughts of suicide), unusual urges (such as increased gambling, sexual urges), worsening of involuntary movements/spasms.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), tingling of the hands/feet, vision changes (e.g., blurred/double vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures, vomit that looks like coffee grounds, black/tarry stools.

Abruptly stopping or reducing the dose of this medication may rarely cause a serious (sometimes fatal) condition (neuroleptic malignant syndrome). Seek immediate medical attention if any of these rare but very serious side effects occur: fast/shallow breathing, confusion, severe dizziness/fainting, high fever, unusual muscle stiffness, unusual sweating.

For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention or permanent problems could occur.

A very serious allergic reaction is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sinemet CR (Carbidopa-Levodopa Sustained Release)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sinemet CR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on SINEMET were randomized to therapy with either SINEMET or SINEMET CR. The adverse experience frequency profile of SINEMET CR did not differ substantially from that of SINEMET, as shown in Table 1.

Table 1: Clinical Adverse Experiences Occurring in 1% or Greater of Patients

Adverse Experience SINEMET CR
n=491 %
SINEMET
n=524 %
Dyskinesia 16.5 12.2
Nausea 5.5 5.7
Hallucinations 3.9 3.2
Confusion 3.7 2.3
Dizziness 2.9 2.3
Depression 2.2 1.3
Urinary tract infection 2.2 2.3
Headache 2.0 1.9
Dream abnormalities 1.8 0.8
Dystonia 1.8 0.8
Vomiting 1.8 1.9
Upper respiratory infection 1.8 1.0
Dyspnea 1.6 0.4
'On-Off' phenomena 1.6 1.1
Back pain 1.6 0.6
Dry mouth 1.4 1.1
Anorexia 1.2 1.1
Diarrhea 1.2 0.6
Insomnia 1.2 1.0
Orthostatic hypotension 1.0 1.1
Shoulder pain 1.0 0.6
Chest pain 1.0 0.8
Muscle cramps 0.8 1.0
Paresthesia 0.8 1.1
Urinary frequency 0.8 1.1
Dyspepsia 0.6 1.1
Constipation 0.2 1.5

Abnormal laboratory findings occurring at a frequency of 1% or greater in approximately 443 patients who received SINEMET CR and 475 who received SINEMET during controlled clinical trials included: decreased hemoglobin and hematocrit; elevated serum glucose; white blood cells, bacteria and blood in the urine.

The adverse experiences observed in patients in uncontrolled studies were similar to those seen in controlled clinical studies.

Other adverse experiences reported overall in clinical trials in 748 patients treated with SINEMET CR, listed by body system in order of decreasing frequency, include:

Body as a Whole

Asthenia, fatigue, abdominal pain, orthostatic effects.

Cardiovascular

Palpitation, hypertension, hypotension, myocardial infarction.

Gastrointestinal

Gastrointestinal pain, dysphagia, heartburn.

Metabolic

Weight loss.

Musculoskeletal

Leg pain.

Nervous System/Psychiatric

Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment.

Respiratory

Cough, pharyngeal pain, common cold.

Skin

Rash.

Special Senses

Blurred vision.

Urogenital

Urinary incontinence.

Laboratory Tests

Decreased white blood cell count and serum potassium; increased BUN, serum creatinine and serum LDH; protein and glucose in the urine.

The following adverse experiences have been reported in postmarketing experience with SINEMET CR:

Cardiovascular

Cardiac irregularities, syncope.

Gastrointestinal

Taste alterations, dark saliva.

Hypersensitivity

Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions).

Nervous System/Psychiatric

Increased tremor, peripheral neuropathy, psychotic episodes including delusions and paranoid ideation, pathological gambling, increased libido including hypersexuality, impulse control symptoms.

Skin

Alopecia, flushing, dark sweat.

Urogenital

Dark urine.

Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations and may occur with SINEMET CR are:

Cardiovascular

Phlebitis.

Gastrointestinal

Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue.

Hematologic

Hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis.

Hypersensitivity

Henoch-Schönlein purpura.

Metabolic

Weight gain, edema.

Nervous System/Psychiatric

Ataxia, depression with suicidal tendencies, dementia, euphoria, convulsions (however, a causal relationship has not been established); bradykinetic episodes, numbness, muscle twitching, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, activation of latent Horner's syndrome, nightmares.

Skin

Malignant melanoma (see also CONTRAINDICATIONS), increased sweating.

Special Senses

Oculogyric crises, mydriasis, diplopia.

Urogenital

Urinary retention, priapism.

Miscellaneous

Faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns.

Laboratory Tests

Abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), bilirubin, Coombs test, uric acid.

Read the entire FDA prescribing information for Sinemet CR (Carbidopa-Levodopa Sustained Release) »

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Sinemet CR - User Reviews

Sinemet CR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Sinemet CR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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