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Methadone Side Effects

PatientsVille

Common Methadone Side Effects


The most commonly reported Methadone side effects (click to view or check a box to report):

Toxicity To Various Agents (601)
Cardiac Arrest (334)
Respiratory Arrest (316)
Completed Suicide (256)
Overdose (197)
Death (147)
Electrocardiogram Qt Prolonged (142)
Torsade De Pointes (97)
Respiratory Depression (82)
Cardio-respiratory Arrest (73)
Somnolence (65)
Accidental Overdose (59)
Nausea (57)
Pulmonary Oedema (57)
Loss Of Consciousness (54)
Vomiting (51)
Confusional State (47)
Pneumonia (40)
Dyspnoea (39)
Syncope (39)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Methadone Side Effects Reported to FDA



Methadone Side Effect Report#9996258
Chest Pain, Local Swelling, Local Swelling, Dyspnoea
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Methadone (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Chest Pain, Local Swelling, Local Swelling, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in female patients, resulting in Chest Pain side effect.
Methadone Side Effect Report#9991516
Mental Status Changes, Hypokalaemia, Pyuria, Bacteriuria, Hypomagnesaemia
This report suggests a potential Methadone Mental Status Changes side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: back pain,pelvic pain,cervix carcinoma and used Methadone (dosage: NA) starting 201112. After starting Methadone the patient began experiencing various side effects, including: Mental Status Changes, Hypokalaemia, Pyuria, Bacteriuria, HypomagnesaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Methadone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mental Status Changes, may still occur.
Methadone Side Effect Report#9982504
Bladder Cancer
This Bladder Cancer problem was reported by a consumer or non-health professional from JP. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cancer pain. On
Nov 10, 2013 this consumer started treatment with Methadone (dosage: 5 Mg (15 Mg Daily Dose)). The following drugs were being taken at the same time: NA. When using Methadone, the patient experienced the following unwanted symptoms/side effects: Bladder CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bladder Cancer, may become evident only after a product is in use by the general population.
Methadone Side Effect Report#9975893
Sickle Cell Anaemia With Crisis, Pneumonia, Hyperaesthesia
This Sickle Cell Anaemia With Crisis side effect was reported by a health professional from Country Not Specified. A 31-year-old male patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Methadone (drug dosage: 240 Mg), which was initiated on NS. Concurrently used drugs:
  • Oxycodone
  • Fentanyl
  • Ketorolac
  • Gabapentin
  • Venlafaxine
.After starting to take Methadone the consumer reported adverse symptoms, such as: Sickle Cell Anaemia With Crisis, Pneumonia, HyperaesthesiaThese side effects may potentially be related to Methadone.
Methadone Side Effect Report#9931935
Suicide Attempt, Intentional Overdose, Leukoencephalopathy, Pneumonia Aspiration, Blood Potassium Increased
This is a report of a 43-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Methadone (dosage: NA, start time: NS), combined with:
  • Diazepam
and developed a serious reaction and side effect(s): Suicide Attempt, Intentional Overdose, Leukoencephalopathy, Pneumonia Aspiration, Blood Potassium Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in female patients, resulting in Suicide Attempt side effect. The patient was hospitalized.
Methadone Side Effect Report#9928936
Prostate Cancer, Somnolence
This report suggests a potential Methadone Prostate Cancer side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: cancer pain and used Methadone (dosage: 20 Mg (60 Mg Daily Dose)) starting
Feb 02, 2012. After starting Methadone the patient began experiencing various side effects, including: Prostate Cancer, SomnolenceAdditional drugs used concurrently: NA. Although Methadone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Prostate Cancer, may still occur.
Methadone Side Effect Report#9928304
Scoliosis, Condition Aggravated, Narcolepsy
This Scoliosis problem was reported by a consumer or non-health professional from US. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On NS this consumer started treatment with Methadone 10 Mg (dosage: NA). The following drugs were being taken at the same time: NA. When using Methadone 10 Mg, the patient experienced the following unwanted symptoms/side effects: Scoliosis, Condition Aggravated, NarcolepsyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Scoliosis, may become evident only after a product is in use by the general population.
Methadone Side Effect Report#9926159
Torsade De Pointes, Electrocardiogram Qt Prolonged, Left Ventricular Dysfunction, Hypokalaemia
This Sudden Death side effect was reported by a health professional from Country Not Specified. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Methadone (drug dosage: 200 Mg), which was initiated on NS. Concurrently used drugs:
  • Dulcolax
.After starting to take Methadone the consumer reported adverse symptoms, such as: Torsade De Pointes, Electrocardiogram Qt Prolonged, Left Ventricular Dysfunction, HypokalaemiaThese side effects may potentially be related to Methadone.
Methadone Side Effect Report#9926104
Torsade De Pointes, Electrocardiogram Qt Prolonged, Left Ventricular Dysfunction, Hypokalaemia
This is a report of a 46-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Methadone (dosage: 200 Mg, start time: NS), combined with:
  • Dulcolax
and developed a serious reaction and side effect(s): Torsade De Pointes, Electrocardiogram Qt Prolonged, Left Ventricular Dysfunction, Hypokalaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in female patients, resulting in Sudden Death side effect.
Methadone Side Effect Report#9925519
Renal Failure Acute, Deafness Bilateral, Mental Status Changes
This report suggests a potential Methadone Renal Failure Acute side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Methadone (dosage: Unk) starting NS. After starting Methadone the patient began experiencing various side effects, including: Renal Failure Acute, Deafness Bilateral, Mental Status ChangesAdditional drugs used concurrently:
  • Amitriptyline (Unk)
  • Allopurinol (Unk)
Although Methadone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Methadone Side Effect Report#9922767
Ototoxicity, Mental Status Changes, Renal Failure Acute
This Ototoxicity problem was reported by a health professional from Country Not Specified. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Methadone (dosage: NA). The following drugs were being taken at the same time:
  • Allopurinol
  • Amitriptyline
When using Methadone, the patient experienced the following unwanted symptoms/side effects: Ototoxicity, Mental Status Changes, Renal Failure AcuteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ototoxicity, may become evident only after a product is in use by the general population.
Methadone Side Effect Report#9921789
Neoplasm Malignant
This Neoplasm Malignant side effect was reported by a physician from JP. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: cancer pain.The patient was prescribed Methadone (drug dosage: 5 Mg (15 Mg Daily Dose)), which was initiated on
Jul 02, 2013. Concurrently used drugs: NA..After starting to take Methadone the consumer reported adverse symptoms, such as: Neoplasm MalignantThese side effects may potentially be related to Methadone.
Methadone Side Effect Report#9911419
Renal Failure Acute, Mental Status Changes, Deafness Bilateral, Deafness
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Methadone (dosage: NA, start time: NS), combined with:
  • Amitriptyline
and developed a serious reaction and side effect(s): Renal Failure Acute, Mental Status Changes, Deafness Bilateral, Deafness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in male patients, resulting in Renal Failure Acute side effect.
Methadone Side Effect Report#9901056
Pleural Mesothelioma
This report suggests a potential Methadone Pleural Mesothelioma side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: cancer pain and used Methadone (dosage: 5 Mg, Tid) starting
Dec 16, 2013. After starting Methadone the patient began experiencing various side effects, including: Pleural MesotheliomaAdditional drugs used concurrently: NA. Although Methadone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pleural Mesothelioma, may still occur.
Methadone Side Effect Report#9899599
Overdose, Toxicity To Various Agents, Cardiac Arrest, Electrocardiogram Qt Prolonged
This Overdose problem was reported by a health professional from FR. A 27-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Methadone (dosage: Most Recently 30mg Daily). The following drugs were being taken at the same time:
  • Valium (Most Recently 50mg Daily)
  • Ibogaine
When using Methadone, the patient experienced the following unwanted symptoms/side effects: Overdose, Toxicity To Various Agents, Cardiac Arrest, Electrocardiogram Qt ProlongedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Overdose, may become evident only after a product is in use by the general population.
Methadone Side Effect Report#9899348
Vomiting, Multi-organ Disorder, Brain Oedema, Pulmonary Oedema
This Death side effect was reported by a health professional from Country Not Specified. A 24-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Methadone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • 3,4-methylenedioxypyrovalerone
.After starting to take Methadone the consumer reported adverse symptoms, such as: Vomiting, Multi-organ Disorder, Brain Oedema, Pulmonary OedemaThese side effects may potentially be related to Methadone.
Methadone Side Effect Report#9899304
Brain Oedema, Pulmonary Oedema, Pulmonary Congestion, Hepatic Congestion, Spleen Congestion
This is a report of a 38-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Methadone (dosage: NA, start time: NS), combined with:
  • Diazepam
  • Vodka
and developed a serious reaction and side effect(s): Brain Oedema, Pulmonary Oedema, Pulmonary Congestion, Hepatic Congestion, Spleen Congestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in male patients, resulting in Death side effect.
Methadone Side Effect Report#9898981
Electrocardiogram Qt Prolonged
This report suggests a potential Methadone Sudden Cardiac Death side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: NA and used Methadone (dosage: 20 Mg) starting NS. After starting Methadone the patient began experiencing various side effects, including: Electrocardiogram Qt ProlongedAdditional drugs used concurrently:
  • Zolpidem (10 Mg)
  • Olanzapine (5 Mg)
  • Clonazepam (1.5 Mg)
  • Mirtazapine (30 Mg)
Although Methadone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sudden Cardiac Death, may still occur.
Methadone Side Effect Report#9898976
Electrocardiogram Qt Prolonged
This Sudden Cardiac Death problem was reported by a health professional from Country Not Specified. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Methadone (dosage: NA). The following drugs were being taken at the same time:
  • Zidovudine (600 Mg)
  • Escitalopram (30 Mg)
  • Atazanavir (400 Mg)
  • Levomepromazine (50 Mg)
  • Lamivudine (300 Mg)
When using Methadone, the patient experienced the following unwanted symptoms/side effects: Electrocardiogram Qt ProlongedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sudden Cardiac Death, may become evident only after a product is in use by the general population.
Methadone Side Effect Report#9898065
Electrocardiogram Qt Prolonged
This Sudden Cardiac Death side effect was reported by a health professional from Country Not Specified. A 25-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Methadone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Lorazepam (15 Mg)
  • Clozapine (100 Mg)
.After starting to take Methadone the consumer reported adverse symptoms, such as: Electrocardiogram Qt ProlongedThese side effects may potentially be related to Methadone.
Methadone Side Effect Report#9897707
Acute Coronary Syndrome, Overdose
This is a report of a 51-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Methadone (dosage: 400 Mg, start time: NS), combined with:
  • Ethanol
and developed a serious reaction and side effect(s): Acute Coronary Syndrome, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in female patients, resulting in Acute Coronary Syndrome side effect. The patient was hospitalized.
Methadone Side Effect Report#9897549
Poisoning Deliberate
This report suggests a potential Methadone Poisoning Deliberate side effect(s) that can have serious consequences. A 4-year-old patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: NA and used Methadone (dosage: NA) starting NS. After starting Methadone the patient began experiencing various side effects, including: Poisoning DeliberateAdditional drugs used concurrently: NA. Although Methadone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning Deliberate, may still occur.
Methadone Side Effect Report#9897479
Electrocardiogram Qt Prolonged, Toxicity To Various Agents, Agitation
This Electrocardiogram Qt Prolonged problem was reported by a health professional from Country Not Specified. A 25-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Methadone (dosage: NA). The following drugs were being taken at the same time:
  • Droperidol
When using Methadone, the patient experienced the following unwanted symptoms/side effects: Electrocardiogram Qt Prolonged, Toxicity To Various Agents, AgitationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Electrocardiogram Qt Prolonged, may become evident only after a product is in use by the general population.
Methadone Side Effect Report#9894849
Multi-organ Disorder
This Death side effect was reported by a health professional from Country Not Specified. A 29-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Methadone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Zopiclone
  • Amphetamine
.After starting to take Methadone the consumer reported adverse symptoms, such as: Multi-organ DisorderThese side effects may potentially be related to Methadone.
Methadone Side Effect Report#9894753
Hepatosplenomegaly, Multi-organ Disorder
This is a report of a 43-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Methadone (dosage: NA, start time: NS), combined with:
  • Clorazepate
  • Amitriptyline
  • Doxepin
  • Pregabalin
and developed a serious reaction and side effect(s): Hepatosplenomegaly, Multi-organ Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methadone treatment in female patients, resulting in Death side effect.


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The appearance of Methadone on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Methadone reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Methadone Side Effects

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    How Effective is Methadone for You?

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    Methadone Safety Alerts, Active Ingredients, Usage Information

    NDC0054-0391
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameMethadone Hydrochloride
    NameMethadone Hydrochloride
    Dosage FormCONCENTRATE
    RouteORAL
    On market since19880430
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)METHADONE HYDROCHLORIDE
    Strength(s)10
    Unit(s)mg/mL
    Pharma ClassFull Opioid Agonists [MoA],Opioid Agonist [EPC]

    Methadone Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2359

    Methadone safety alerts: 2006

    Reported deaths: 1127

    Reported hospitalizations: 332

    Dolophine (methadone hydrochloride)

    Audience: Pain management specialists, pharmacists, and other healthcare professionals
    Indication: Treatment of moderate to severe pain not responsive to non-narcotic analgesics; detoxification of opioid addiction; and maintenance treatment of opioid addiction
    [Posted 11/27/2006] FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes). The reports underscore the importance of knowing methadone's toxicities and unique pharmacologic properties, including dosing and monitoring recommendations.

    [November 27, 2006 - Public Health Advisory - FDA]
    [November 27, 2006 - Healthcare Professional Sheet - FDA]
    [November 27, 2006 - Prescribing Information - Roxane]

    Latest Methadone clinical trials