Plasma protein binding of duloxetine is not affected by renal or hepatic impairment. Biotransformation and disposition of duloxetine in humans have been determined following oral administration of 14 C-labeled duloxetine. The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation.
Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate. Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Duloxetine undergoes extensive metabolism, but the major circulating metabolites have not been shown to contribute significantly to the pharmacologic activity of duloxetine. Duloxetine steady-state plasma concentration was comparable in pediatric patients 7 to 17 years of age and adult patients.
The model-predicted duloxetine steady state plasma concentrations in pediatric patients 7 to 17 years of age were mostly within the concentration range observed in adult patients and did not exceed the concentration range in adults.
Duloxetine was not mutagenic in the in vitro bacterial reverse mutation assay Ames test and was not clastogenic in an in vivo chromosomal aberration test in mouse bone marrow cells.
Additionally, duloxetine was not genotoxic in an in vitro mammalian forward gene mutation assay in mouse lymphoma cells or in an in vitro unscheduled DNA synthesis UDS assay in primary rat hepatocytes, and did not induce sister chromatid exchange in Chinese hamster bone marrow in vivo. Additionally, a summary of the following trials that did not demonstrate efficacy are presented below: Study FM-3 a week trial in adult patients with fibromyalgia , Study CLBP-2 a week trial in adult patients with CLBP , and Study OA-2 a week trial in adult patients with chronic pain due to OA.
In all of these clinical trials, analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics. SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval, not adjusted for multiplicity in trials where multiple dose groups were included. In Studies GAD-1 and GAD-2, the starting dose was 60 mg once daily down titration to 30 mg once daily was allowed for tolerability reasons; the dosage could be increased to 60 mg once daily.
Fifteen percent of patients were down titrated. Study GAD-3 had a starting dose of 30 mg once daily for 1 week before increasing it to 60 mg once daily.
The mean dosage for completers at endpoint in these trials was Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender. In Study GAD-5, the starting dose was 30 mg once daily for 2 weeks before further dose increases in 30 mg increments at treatment weeks 2, 4, and 7 up to mg once daily were allowed based on investigator judgment of clinical response and tolerability.
The mean dosage for patients completing the week acute treatment phase was 51 mg. In Study GAD-6, the starting dosage was 30 mg once daily for 2 weeks. Further dosage increases in 30 mg increments up to mg once daily were allowed based on investigator judgment of clinical response and tolerability. The mean dosage for patients completing the week treatment phase was Patients enrolled had Type I or II diabetes mellitus with a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for at least 6 months.
Patients recorded their pain daily in a diary. For various degrees of improvement in pain from baseline to study endpoint, Figures 3 and 4 show the fraction of patients achieving that degree of improvement in Studies DPNP-1 and DPNP-2, respectively.
Some patients experienced a decrease in pain as early as week 1, which persisted throughout the trial. The efficacy of CYMBALTA for the management of fibromyalgia in adults was established in two randomized, double-blind, placebo-controlled, fixed-dose trials in adult patients meeting the American College of Rheumatology criteria for fibromyalgia a history of widespread pain for 3 months, and pain present at 11 or more of the 18 specific tender point sites.
Study FM-1 was three months in duration and enrolled female patients only. Study FM-2 was six months in duration and enrolled male and female patients. The patients had a baseline pain score of 6. Pain reduction was observed in patients both with and without comorbid MDD. However, the degree of pain reduction may be greater in patients with comorbid MDD. For various degrees of improvement in pain from baseline to study endpoint, Figures 5 and 6 show the fraction of patients achieving that degree of improvement in Studies FM-1 and FM-2, respectively.
Improvement was also demonstrated on measures of function Fibromyalgia Impact Questionnaires and patient global impression of change PGI. Neither trial demonstrated a benefit of mg compared to 60 mg, and a higher dosage was associated with more adverse reactions and premature discontinuations of treatment. The patients had a baseline BPI of 5. For various degrees of improvement in pain from baseline to study endpoint, Figure 7 shows the fraction of patients achieving that degree of improvement in Study FM This has been established in trials in adult patients with chronic low back pain and chronic pain due to osteoarthritis.
Patients in all trials had no signs of radiculopathy or spinal stenosis. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 no pain to 10 worst possible pain. Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use. For various degrees of improvement in pain from baseline to study endpoint, Figures 8 and 9 show the fraction of patients in Studies CLBP-1 and CLBP-3 achieving that degree of improvement, respectively.
All patients in both trials fulfilled the ACR clinical and radiographic criteria for classification of idiopathic OA of the knee. However, in Study OA-2, all patients, regardless of their response to treatment after 7 weeks, were re-randomized to either continue receiving CYMBALTA 60 mg once daily or have their dosage increased to mg once daily for the remainder of the trial.
Patients in the placebo treatment groups in both trials received a matching placebo for the entire duration of trials. For both trials, efficacy analyses were conducted using week data from the combined CYMBALTA 60 mg and mg once daily treatment groups compared to the placebo group.
Patients had a mean baseline pain of 6 on a numerical rating scale ranging from 0 no pain to 10 worst possible pain. In Study OA-1, for various degrees of improvement in pain from baseline to study endpoint, Figure 10 shows the fraction of patients achieving that degree of improvement. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions? Cymbalta and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness also called manic-depressive illness. How can I watch for and try to prevent suicidal thoughts and actions? Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you.
In an emergency, call Cymbalta belongs to a class of medicines known as SNRIs or serotonin-norepinephrine reuptake inhibitors. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Cymbalta and some medicines may interact with each other, may not work as well, or may cause serious side effects. Monitor your blood pressure before starting and throughout treatment. Cymbalta may:. Serotonin Syndrome: This condition can be life-threatening and symptoms may include:. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.
Stopping Cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including:. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
Elderly people may be at greater risk for this. Symptoms may include:. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with CYMBALTA.
There may be treatments your healthcare provider can suggest. Side effects in adults may also occur in children and adolescents who take Cymbalta. Children and adolescents should have height and weight monitored during treatment.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Cymbalta. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Cymbalta for a condition for which it was not prescribed. Do not give Cymbalta to other people, even if they have the same symptoms that you have.
It may harm them. This Medication Guide summarizes the most important information about Cymbalta. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Cymbalta that is written for healthcare professionals. This Medication Guide has been approved by the U.
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Approval: Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants 5. Swallow whole; do not crush, chew, or open capsule 2. Discontinue CYMBALTA in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established.
Avoid use in patients with substantial alcohol use or evidence of chronic liver disease 5. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk 5. Screening Patients for Bipolar Disorder A major depressive episode may be the initial presentation of bipolar disorder.
Hepatic Impairment Avoid use in patients with chronic liver disease or cirrhosis [see Dosage and Administration 2. The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions 5. Generalized Anxiety Disorder Approximately Diabetic Peripheral Neuropathic Pain Approximately Fibromyalgia Approximately Chronic Pain due to Osteoarthritis Approximately Chronic Low Back Pain Approximately Fibromyalgia: nausea, dry mouth, constipation, somnolence, decreased appetite, hyperhidrosis, and agitation.
Chronic Pain due to Osteoarthritis: nausea, fatigue, constipation, dry mouth, insomnia, somnolence, and dizziness. Chronic Low Back Pain: nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue. Effects on Male and Female Sexual Function in Adults with MDD Changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetes, but they may also be a consequence of pharmacologic treatment. Cardiac Disorders — Frequent: palpitations; Infrequent: myocardial infarction, tachycardia, and Takotsubo cardiomyopathy.
Ear and Labyrinth Disorders — Frequent: vertigo; Infrequent: ear pain and tinnitus. Endocrine Disorders — Infrequent: hypothyroidism. Eye Disorders — Frequent: vision blurred; Infrequent: diplopia, dry eye, and visual impairment. Gastrointestinal Disorders — Frequent: flatulence; Infrequent: dysphagia, eructation, gastritis, gastrointestinal hemorrhage, halitosis, and stomatitis; Rare: gastric ulcer. Infections and Infestations — Infrequent: gastroenteritis and laryngitis.
Investigations — Frequent: weight increased, weight decreased; Infrequent: blood cholesterol increased. Metabolism and Nutrition Disorders — Infrequent: dehydration and hyperlipidemia; Rare: dyslipidemia.
Musculoskeletal and Connective Tissue Disorders — Frequent: musculoskeletal pain; Infrequent: muscle tightness and muscle twitching. Renal and Urinary Disorders — Frequent: urinary frequency; Infrequent: dysuria, micturition urgency, nocturia, polyuria, and urine odor abnormal. Respiratory, Thoracic and Mediastinal Disorders — Frequent: yawning, oropharyngeal pain; Infrequent: throat tightness.
Skin and Subcutaneous Tissue Disorders — Frequent: pruritus; Infrequent: cold sweat, dermatitis contact, erythema, increased tendency to bruise, night sweats, and photosensitivity reaction; Rare: ecchymosis.
Vascular Disorders — Frequent: hot flush; Infrequent: flushing, orthostatic hypotension, and peripheral coldness. Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage.
Clinical Considerations. Maternal Adverse Reactions Use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions 5. Data Human Data Data from a postmarketing retrospective claims-based cohort study found an increased risk for postpartum hemorrhage among pregnant women exposed to duloxetine in the last month of pregnancy compared to 4,, unexposed pregnant women adjusted relative risk: 1.
Distribution The apparent volume of distribution averages about L. Elimination Metabolism Biotransformation and disposition of duloxetine in humans have been determined following oral administration of 14 C-labeled duloxetine. Excretion Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Specific Populations Pediatric Patients Duloxetine steady-state plasma concentration was comparable in pediatric patients 7 to 17 years of age and adult patients.
Mutagenesis Duloxetine was not mutagenic in the in vitro bacterial reverse mutation assay Ames test and was not clastogenic in an in vivo chromosomal aberration test in mouse bone marrow cells. Suicidal Thoughts and Behaviors — Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions 5.
Administration — Advise patients to swallow CYMBALTA whole and to not chew, crush, or open the capsule do not sprinkle contents on food or mixed with liquids because these actions might affect the enteric coating. Instruct patients to talk to their healthcare provider about their alcohol consumption. Orthostatic Hypotension, Falls and Syncope — Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of CYMBALTA [see Warnings and Precautions 5.
Serotonin Syndrome — Caution patients about the risk of serotonin syndrome with the concomitant use of CYMBALTA and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John's Wort [see Contraindications 4 , Warnings and Precautions 5. Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes e.
Caution patients to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding — Caution patients about the concomitant use of CYMBALTA and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions 5.
Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions 5. Discontinuation of Treatment — Instruct patients that discontinuation of CYMBALTA may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking CYMBALTA without consulting their healthcare provider [see Warnings and Precautions 5.
Activation of Mania or Hypomania — Adequately screen patients with depressive symptoms for risk of bipolar disorder e.
Advise patients to report any signs or symptoms of a manic reaction such as greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, talking more or faster than usual, unusually grand ideas, and excessive happiness or irritability [see Warnings and Precautions 5. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy.
Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure e. Seizures — Advise patients to inform their healthcare provider if they have a history of seizure disorder [see Warnings and Precautions 5.
Concomitant Medications — Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter medications, since there is a potential for interactions [see Dosage and Administration 2. Advise patients of the signs and symptoms of hyponatremia [see Warnings and Precautions 5.
Concomitant Illnesses — Advise patients to inform their healthcare provider about all of their medical conditions [see Warnings and Precautions 5. Instruct patients to consult with their healthcare provider if they develop any problems with urine flow [see Warnings and Precautions 5. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions 5.
Advise pregnant women or patients who intend to become pregnant that CYMBALTA use during the month before delivery may lead to an increased risk for postpartum hemorrhage and may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding. Advise pregnant women that there is a risk of relapse with discontinuation of antidepressants.
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to duloxetine during pregnancy [see Use in Specific Populations 8. Therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that CYMBALTA therapy does not affect their ability to engage in such activities. All rights reserved. Talk to your healthcare provider about: all risks and benefits of treatment with antidepressant medicines all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?
Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. If you have questions about how Cymbalta works, or how long it takes to work, talk with your doctor or pharmacist. Cymbalta can interact with several other medications. It can also interact with certain supplements. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works.
Other interactions can increase side effects or make them more severe. Below are lists of medications that can interact with Cymbalta.
Before taking Cymbalta, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use.
Sharing this information can help you avoid potential interactions. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. Cymbalta can increase serotonin levels in your body. Using Cymbalta with other drugs that also increase serotonin may raise your risk for serotonin syndrome. Serotonin syndrome is a rare but potentially life threatening condition.
Taking multiple medications that increase serotonin levels could cause serotonin to build up to dangerous levels in your blood. Before taking Cymbalta, be sure to tell your doctor if you take any of the medications listed above. They may want to monitor you for any signs of serotonin syndrome. Or they may have you take a different drug to treat your condition. Taking Cymbalta with these drugs may increase Cymbalta levels in your body. Slowing down this process could raise your risk for side effects from Cymbalta.
Certain drugs have stronger effects on these enzymes. Examples of strong CYP1A2 inhibitors include:. Examples of CYP2D6 inhibitors include:. Before you take Cymbalta, be sure to tell your doctor if you take any of these medications. They can determine which drug is the best fit for you. This means it can affect the levels of other drugs that are also broken down by this enzyme.
However, some medications can cause side effects if their levels in your body are changed slightly. Examples of these drugs include:. Before taking Cymbalta, talk with your doctor about all the medications you take. They can determine whether Cymbalta can be taken with your other medications.
Drugs that affect serotonin levels, such as Cymbalta, may increase your risk for bleeding. Before taking Cymbalta, tell your doctor if you take any of the medications listed above. This monitoring may include ordering blood tests. Or they may decide to use a different medication to treat your condition.
This is an herb that can be used to treat depression. Cymbalta can raise your serotonin levels. Because St. If you have any questions about eating certain foods with Cymbalta, talk with your doctor. Clinical studies of the drug have shown that taking it the month before delivery may increase the risk of severe bleeding immediately afterward postpartum hemorrhage.
The manufacturer of Cymbalta maintains a pregnancy registry. The registry tracks the results of pregnant people taking the drug. You can join this registry online or by calling You should also tell your doctor right away if you become pregnant while taking this drug.
You can take Cymbalta at any time of the day. However, you should try to take it around the same time every day. This helps make sure you have a consistent amount of the drug in your body. The best time for you to take Cymbalta may depend on what you use the drug for and how often you take it each day.
Your doctor can help you decide the best time for you to take Cymbalta. Doing so may affect how well your body absorbs the drug. This could raise your risk for side effects or make the drug less effective. You can also call the American Association of Poison Control Centers at or use their online tool. But if your symptoms are severe, call or your local emergency number, or go to the nearest emergency room right away.
As with all medications, the cost of Cymbalta can vary. To find current prices for Cymbalta in your area, check out GoodRx. The cost you find on GoodRx. Before approving coverage for Cymbalta, your insurance company may require you to get prior authorization.
This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered. If you need financial support to pay for Cymbalta, or if you need help understanding your insurance coverage, help is available. Cymbalta is available in a generic form called duloxetine. And generics tend to cost less than brand-name drugs.
To find out how the cost of duloxetine compares to the cost of Cymbalta, visit GoodRx. They may have a preference for one version or the other. If you have questions about using other drugs with Cymbalta, talk with your doctor or pharmacist. They can review your medications and discuss treatment options with you. Cymbalta may cause harm to a fetus. However, more research is needed in this area.
However, there have been a few reports of drowsiness, poor feeding , and trouble gaining weight in infants exposed to breast milk containing duloxetine. Duloxetine is the active drug in Cymbalta. If you choose to breastfeed while taking Cymbalta, you should watch for any trouble feeding or drowsiness in your child. Together, you can weigh the risks and benefits of breastfeeding while taking the drug and discuss your other treatment and feeding options.
This drug has a boxed warning. A boxed warning alerts doctors and patients about drug effects that may be dangerous. Clinical studies have shown antidepressants such as Cymbalta increase the risk of suicidal thoughts and behaviors in children and young adults ages 24 years or younger.
In people ages 65 and older, antidepressants can actually reduce this risk. Before taking Cymbalta, talk with your doctor about your health history. Cymbalta may not be right for you if you have certain medical conditions or other factors affecting your health. These include:. When you get Cymbalta from the pharmacy, the pharmacist will add an expiration date to the label on the bottle.
This date is typically 1 year from the date they dispensed the medication. The expiration date helps guarantee that the medication is effective during this time. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it. How long a medication remains good can depend on many factors, including how and where you store the medication.
Avoid storing this medication in areas where it could get damp or wet, such as bathrooms. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication. Cymbalta capsules are available in three strengths: 20 milligrams mg , 30 mg, and 60 mg. It can be taken with or without food.
The exact mechanism by which Cymbalta treats MDD, GAD, diabetic neuropathy, fibromyalgia, and chronic musculoskeletal pain is not known. Cymbalta is classified as a serotonin-norepinephrine reuptake inhibitor SNRI. The active drug ingredient in Cymbalta, duloxetine, inhibits neuronal serotonin and norepinephrine reuptake.
To a lesser extent, duloxetine also inhibits dopamine reuptake. The effect of this on drug interactions is unknown. Food delays the time it takes for duloxetine to reach peak concentration, from 6 hours to 10 hours. However, this has no overall effect on maximum concentrations. Do not start Cymbalta in patients treated with MAOIs , including linezolid and intravenous methylene blue.
This can increase the risk of serotonin syndrome. Cymbalta is contraindicated for 14 days after stopping an MAOI intended to treat a psychiatric disorder. Counsel Cymbalta users that treatment should not be stopped without talking with their prescriber.
Cymbalta should be gradually tapered to avoid discontinuation syndrome. If someone experiences withdrawal symptoms during their Cymbalta taper, consider returning to the previously prescribed dose. Once withdrawal symptoms subside, the taper can be continued at a more gradual rate. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date.
However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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