"An intranasal form of naloxone hydrochloride (Narcan, Adapt Pharma, Inc), a drug that stops or reverses opioid overdose, has been approved by the US Food and Drug Administration (FDA) under a fast-track approval process.
Dolophine Side Effects Center
Pharmacy Editor: Omudhome Ogbru, PharmD
Dolophine (methadone) is an oral and injectable opioid used for treatment of pain and opioid or heroin addiction. A generic formulation of Dolophine is available. Common side effects of Dolophine include lightheadedness, nausea, vomiting, diarrhea, constipation, loss of appetite, dizziness, anxiety, nervousness, restlessness, sleep problems (insomnia), weakness, drowsiness, dry mouth, sedation, sweating, decreased sex drive, impotence, or difficulty having an orgasm. Dolophine can be abused and causes withdrawal symptoms.
Rifadin (rifampin), Tegretol (carbamazepine), and Dilantin (phenytoin) may decrease blood levels of Dolophine. Vfend (voriconazole) may increase serum concentrations of Dolophine. Dolophine has not been adequately evaluated in pregnant women. Children of women treated with Dolophine during pregnancy have exhibited mild but persistent deficits in performance on psychometric and behavioral tests. They may also exhibit withdrawal symptoms. Dolophine is secreted into breast milk.
Our Dolophine 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.
Dolophine in Detail - Patient Information: Side Effects
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:
- shallow breathing;
- hallucinations or confusion;
- chest pain, dizziness, fainting, fast or pounding heartbeat; or
- trouble breathing, feeling light-headed, or fainting.
Less serious side effects may include:
- feeling anxious, nervous, or restless;
- sleep problems (insomnia);
- feeling weak or drowsy;
- dry mouth, nausea, vomiting, diarrhea, constipation, loss of appetite; or
- decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Dolophine (Methadone)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Dolophine Overview - Patient Information: Side Effects
Nausea, vomiting, constipation, lightheadedness, dizziness, dry mouth, drowsiness, or sweating may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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.
Tell your doctor right away if you have any unlikely but serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating.
Get medical help right away if you have any rare but serious side effects, including: seizure, unusual drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 Dolophine (Methadone)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Dolophine FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- QT Prolongation[see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants[see WARNINGS AND PRECAUTIONS]
- Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable.
Other adverse reactions include the following:
Body as a Whole: asthenia (weakness), edema, headache
Cardiovascular: arrhythmias, bigeminal rhythms, bradycardia, cardiomyopathy, ECG abnormalities, extrasystoles, flushing, heart failure, hypotension, palpitations, phlebitis, QT interval prolongation, syncope, T-wave inversion, tachycardia, torsades de pointes, ventricular fibrillation, ventricular tachycardia
Renal: antidiuretic effect, urinary retention or hesitancy
Respiratory: pulmonary edema, respiratory depression
Hypersensitivity: Anaphylaxis has been reported with ingredients contained in DOLOPHINE. Advise patients how to recognize such a reaction and when to seek medical attention.
Maintenance on a Stabilized Dose: During prolonged administration of methadone, as in a methadone maintenance treatment program, constipation and sweating often persist and hypogonadism, decreased serum testosterone and reproductive effects are thought to be related to chronic opioid use.
DOLOPHINE for the Detoxification and Maintenance Treatment of Opioid Dependence: During the induction phase of methadone maintenance treatment, patients are being withdrawn from illicit opioids and may have opioid withdrawal symptoms. Monitor patients for signs and symptoms including: lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose-flesh, fever, chilling alternating with flushing, restlessness, irritability, weakness, anxiety, depression, dilated pupils, tremors, tachycardia, abdominal cramps, body aches, involuntary twitching and kicking movements, anorexia, nausea, vomiting, diarrhea, intestinal spasms, and weight loss and consider dose adjustment as indicated.
Read the entire FDA prescribing information for Dolophine (Methadone)
Additional Dolophine Information
Dolophine - User Reviews
Dolophine User Reviews
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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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