Cymbalta withdrawal. Cymbalta withdrawal side effects, withdrawal warnings, withdrawal precautions, withdrawal adverse effects, overdose, withdrawal symptoms and natural alternatives. Before you begin the spiral down with Cymbalta, try giving your body what it really wants.

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CYMBALTA

Below is a list of Cymbalta withdrawal side effects. These Cymbalta side effects can occur while taking the Cymbalta before withdrawal or may become apparent once Cymbalta withdrawal begins. It is imperative you use a Cymbalta withdrawal plan designed to eliminate or reduce Cymbalta withdrawal side effects. Once Cymbalta withdrawal side effects begin, they are more difficult to get rid of.

If you have a detached retina and you were taking Cymbalta, there may be a connection. A detached retina is a Cymbalta side effect.

Cymbalta and Birth Defects

Cymbalta (duloxetine) is in a class of drugs known as SNRIs (Selective Serotonin/Norepinephrine Reuptake Inhibitors) (similar to SSRIs) and is an antidepressant that is used to treat depression and anxiety. However, Cymbalta as well as other antidepressants are not proven to be much more effective than placebo.

Cymbalta has been linked to serious side effects including heart defects and persistent pulmonary hypertension in the newborn (PPHN) when Cymbalta is taken by the mothers during pregnancy.

In July of 2006, the FDA issued a Health Advisory advising people of serious side effects if taking Cymbalta  while pregnant. The New England Journal of Medicine published a study that showed mothers who took Cymbalta during the second half of their pregnancy were six times more likely to have a baby with PPHN or heart defects.

Eli Lilly, makers of Cymbalta, have allegedly failed to adequately warn users that birth defects are a possible side effect of taking Cymbalta during pregnancy.

Eli Lilly announced today, February 26, 2007, that the U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta (R) (duloxetine HCl) for the treatment of generalized anxiety disorder (GAD). However, Cymbalta is known to cause anxiety once side effects begin in roughly 50% of the population.

Cymbalta tends to cause intestinal problems as well as joint pain more often than other Cymbalta side effects while a person is still taking the medication. Much like other antidepressants, Cymbalta causes side effects in the very symptom they are promoted to solve. Hence, Cymbalta joint pain.

To read more about Cymbalta from the FDA, click here and type Cymbalta in search box.

1. Cymbalta withdrawal - Anorexia – No longer having a desire to eat.
    

2. Cymbalta withdrawal - Apothous Stomatitis – Painful red and swollen open sores on a mucus membrane of the mouth commonly called a canker sore.
    

3. Cymbalta withdrawal - Ataxia – Loss of the ability to move the body with coordination.
    

4. Cymbalta withdrawal - Arterial Fibrillation – A condition of abnormal twitching of the muscles in the blood vessels that moves the oxygenated blood from the heart to the rest of the body.  The unusual twitching is rapid and irregular and replaces the normal rhythm of contraction of the muscle, which sometimes causes a lack of circulation and pulse.
    

5. Cymbalta withdrawal - Blood Cholesterol Increased – An abnormal condition where there is a greater amount in the blood of the oily/fatty substances known as cholesterol.   Cholesterol is a necessary part of living cells (along with proteins and carbohydrates).  Because cholesterol only slightly dissolves in water, it can build up on the walls of the blood vessels, therefore blocking/decreasing the amount of blood flow, which causes blood pressure to go up.  If not corrected, this condition is associated with coronary artery disease.
    

6. Cymbalta withdrawal - Blood Creatinine Increased – A greater than normal number of creatinine or muscular chemical waste molecules in the blood.  Creatinine plays a major role in energy production in muscles.  Since creatinine levels are normally maintained by the kidneys, Blood Creatinine Increased is an indicator of kidney malfunction or failure.
    

7. Cymbalta withdrawal - Blood in Stool – The blood that is in your bowel movement usually comes from any place along your digestive tract (from your mouth to your anus).  The stool can appear black and foul-smelling (usually from the upper part of your digestive tract) or red or maroon-colored (usually from the large intestine area).  Hemorrhoids are the usual cause for blood in the bowels.

8.    Cymbalta withdrawal - Bundle Branch Block Right – These are specialized cells in the upper right heart chamber and are the heart’s pacemaker.  They send electrical signals to the heart that keeps it beating or contracting regularly.  Normally the signal goes to the lower heart chambers at the same time through the bundle of His (hiss) on both the left and right sides of the heart, so the lower chambers contract at the same time.  When the bundle is damaged on the right side, the signal does not fire at the same time as the left, which changes the pace of blood flow.  This can lead to a person fainting.

9. Cymbalta withdrawal - Cardiac Failure – A heart disorder where the heart does not function as usual and may completely stop working.
    

10. Cymbalta withdrawal - Cardiac Failure Congestive – The body is asking for the heart to supply more blood than it is capable of producing and maintaining.  Normally, a body can tolerate an increased amount of work for quite some time.  The condition is characterized by weakness, shortness of breath, and a fluid build-up in the body tissues causing swelling.
     

11. Cymbalta withdrawal - Cold Sweat – The skin is clammy and moist and you feel chilled.  This is a reaction to a shock or pain as well as to fear and nervousness.
     

12. Cymbalta withdrawal - Colitis – A condition where the large intestine becomes irritated from the use of the drug.
     

13. Cymbalta withdrawal - Coronary Artery Disease – A condition where the blood vessels that mainly carry the blood away from the heart become clogged up or narrowed usually by fatty deposits.  The first symptom is pain spreading from the upper left body caused by not enough oxygen reaching the heart.
     

14. Cymbalta withdrawal - Dehydration – An extreme loss of water from the body or the organs of the body as in sickness or not drinking enough fluids.
     

15. Cymbalta withdrawal - Diplopia – The condition where a person is looking a one object and instead of normally seeing just the one object he sees two.  This is also call double vision.
     

16. Cymbalta withdrawal - Diverticulitis – There are pouches or sacs on the inside of the intestines that look like fingers.  This increases the area for the body to absorb nutrients as they pass through the intestines.  These sacs become irritated and swollen and end up trapping waste that would normally be eliminated, causing pain and constipation.
     

17. Cymbalta withdrawal - Dysarthria – The inability to control the mouth muscles when forming words so the words are not clearly spoken and heard.
     

18. Cymbalta withdrawal - Dyslipidemia – The normal fat metabolism in the blood is interfered with.
     

19. Cymbalta withdrawal - Dysphagia – Trouble swallowing or the inability to swallow.
     

20. Cymbalta withdrawal - Ecchymosis – When a blood vessel breaks and creates a purple discoloration of the skin.
     

21. Cymbalta withdrawal - Edema – An abnormal build up of excess fluids in the cells, tissues, and the spaces between the tissues creating swelling.
     

22. Cymbalta withdrawal - Edema Peripheral – The abnormal build up of fluids in the tissues of the ankles and legs causing painless swelling in the legs, ankles, and feet.  If you squeeze the swollen area it leaves an indentation on the skin for a few minutes.
     

23. Cymbalta withdrawal - Ejaculation Delayed – The man is not able to release sperm either during sexual intercourse or with manual stimulation in the presence of his sexual partner in spite of his wish to do so.
     

24. Cymbalta withdrawal - Ejaculation Dysfunction – A condition where the man has one or more of the following symptoms:  He is not able to have an erection, not able to have an orgasm, has a decreased interest in sex, is sexually inhibited, or it is painful to ejaculate sperm.
     

25. Cymbalta withdrawal - Erectile Dysfunction – Incapable of having sexual intercourse.  Even though a man desires sex he is inhibited in his sexual activity and is unable to have or maintain an erection of the penis.
     

26. Cymbalta withdrawal - Erythema – a skin redness caused by the swelling with blood of the tiny blood vessels of the skin as in burns.
     

27. Cymbalta withdrawal - Erythematous Rash – Redness of the skin from the swelling of the tiny blood vessels with skin irritation (itching, burning, tingling, pain) and breakouts (eruptions).

28. Cymbalta withdrawal - Esophageal Stenosis Acquired – The tube that moves food from the mouth to the stomach narrows.
     

29. Cymbalta withdrawal - Exfoliative Dermatitis – The unusual and not normal condition of scaling and shedding of the skin cells.  The skin is usually red colored.
     

30. Cymbalta withdrawal - Face Edema – The tissues of the face become swollen.
     

31. Cymbalta withdrawal - Feeling Jittery – A physical sensation of nervous unease.
     

32. Cymbalta withdrawal - Gastric Irritation – An inflamed and sore stomach.
     

33. Cymbalta withdrawal - Gastric Ulcer – An open, irritated, and infected sore in the wall of the stomach.
     

34. Cymbalta withdrawal - Gingivitis – Sore, swollen and red gums in the mouth that bleed easily.
     

35. Cymbalta withdrawal - Glaucoma – The delicate nerve to the eye, the optic nerve, becomes easily damaged with the build-up of excess fluid pressure within the eyeball.  The first sign of glaucoma is loss of peripheral (side) vision.  It can progress to total blindness.
     

36. Cymbalta withdrawal - Hepatic Steatosis – Excessive amounts of fat in the liver.
     

37. Cymbalta withdrawal - Hyperhidrosis – The triggering of an excess of sweat being produced on the soles of the feet, the palms, or the underarms which can cause embarrassment or losing grip on a pen or other items.
     

38. Cymbalta withdrawal - Hyperkeratosis – An abnormal enlargement of the skin tissues causing the skin cells to increase in size.
     

39. Cymbalta withdrawal - Hyperlipidemia – An abnormally high number of fat cells in the blood.
     

40. Cymbalta withdrawal - Hypertriglyceridemia – Too many triglycerides in the blood. 

Triglycerides are three fatty acids bound together in one molecule stored by the body and available to create high levels of energy when used. 

41. Cymbalta withdrawal - Hypoesthesia – A partial loss of sensation or general loss of awareness.
     

42. Cymbalta withdrawal - Impaired Gastric Emptying – The contents of the stomach are not passed into the intestines as normal due to the stomach losing the muscular strength to do so.
     

43. Cymbalta withdrawal - Increased White Blood cell Count – This is an increase in the number of cells in the blood that are responsible for the removal of bacteria and other unwanted particles.  They fight disease and infection by enclosing foreign particles and removing them.  An example of a disease that would increase white blood cell count would be Leukemia.
     

44. Cymbalta withdrawal - Insomnia – Not able to fall asleep or sleeping for a shorter time than desired, thus not being able to properly rest and feeling un-refreshed.  As a result, a person can become irritable, have difficulty concentrating and feel a lack of energy.  This can be caused by stimulants such as by caffeine or drugs or by mental anxiety and stress.  Mental stress can be communicated and relieved.
     

45. Cymbalta withdrawal - Irritable Bowel Syndrome – A painful condition where the either the muscles or the nerves of the lower intestines, are not responding normally.  This results in an alternating condition of diarrhea followed by constipation, back and forth.
     

46. Cymbalta withdrawal - Keratoconjunctivitis Sicca – A condition where the outer coating of the eyeball is dry because of a decrease in the normal amount of tears in the eye.  As a result, the eyeball and inside of the eyelid thickens and hardens sometimes causing the vision to be less sharp.
     

47. Cymbalta withdrawal - Leukopenia – An unnaturally low number of white blood cells circulating in the blood.
     

48. Cymbalta withdrawal - Loose Stools – The bowel movement is runny instead of formed.
     

49. Cymbalta withdrawal - Lower Abdominal Pain – A hurtful irritation of the nerve endings in the area of the hipbones housing the lower digestive tract.  Pain usually means tissue damage.
     

50. Cymbalta withdrawal - Lymphadenopathy – The lymph nodes, where the immune cells are located, become larger than is normal because of a high concentration of white blood cells.
     

51. Cymbalta withdrawal - Macular Degeneration – The gradual loss of central vision, which is the sharpest vision while peripheral eyesight, is unaffected.
     

52. Cymbalta withdrawal - Maculopathy – An abnormal condition of the yellow spot of the eye, which is located in the center of the inner lining of the eyeball and connected to the main nerve to the eye and is responsible for sharp vision.
     

53. Cymbalta withdrawal - Mania – Unusually irrational, excessive and/or exaggerated behavior or moods ranging from enthusiasm, sexuality, gaiety, impulsiveness and irritability to violence.
     

54. Cymbalta withdrawal - Melena – Abnormally darkly colored stools as a result of hemorrhaging in the digestive tract where the blood has interacted with the digestive juices creating the dark color in the bowel movement.
     

55. Cymbalta withdrawal - Micturition Urgency – A sudden desire to urinate usually followed by leakage.
     

56. Cymbalta withdrawal - Mood Swings – An emotional shifting as from a state of happiness to a state of depression for a period of time.
     

57. Cymbalta withdrawal - Myocardial Infarction – The blood going to the heart is delayed or stopped causing middle muscle tissue in the heart wall to die.
     

58. Cymbalta withdrawal - Nasopharyngitis – Irritation, redness and swelling tissues in the nose and the tube leading from the mouth to the voice box as well as the tubes leading to the ears.
     

59. Cymbalta withdrawal - Nephropathy – An abnormally functioning or diseased kidney.
     

60. Cymbalta withdrawal - Nervousness – Jumpy, jittery, anxious, and troubled with an irritable temperament.
     

61. Cymbalta withdrawal - Night Sweats – The water-salt, waste product the skin releases is called sweat or perspiration.   With night sweats you become wide awake in the middle of the night shivering and cold and wet with your sheets/pajamas soaked in perspiration making it difficult to go back to sleep.
     

62. Cymbalta withdrawal - Nightmare – Dreams that make you afraid or leave feelings of fear, terror, and upset long after waking up.
     

63. Cymbalta withdrawal - Orgasm Abnormal – Unable to have an orgasm with normal sexual stimulation.
     

64. Cymbalta withdrawal - Oropharyngeal Swelling – A swelling in the area from the soft part of the roof of the mouth to the back of the mouth.
     

65. Cymbalta withdrawal - Pain in Extremity – A painful feeling in the legs, arms, hands, and feet.
     

66. Cymbalta withdrawal - Pharyngolaryngeal Pain – Pain in the area of the respiratory tract (organs of breathing) from the throat to the voice box and above the windpipe.
     

67. Cymbalta withdrawal - Photopsia – A condition where a person see lights, sparks or colors in front of your eyes.
     

68. Cymbalta withdrawal - Photosensitivity Reaction – An exaggerated sunburn reaction that is not normal in proportion to the amount of exposure to the light.
     

69. Cymbalta withdrawal - Pollakiuria – Urinating much more frequently than normal – as often as once every five to fifteen minutes.
     

70. Cymbalta withdrawal - Pressure of Speech – A condition where the individual cannot voice his ideas fast enough with the pressure of there being not enough time to say it.
     

71. Cymbalta withdrawal - Pruritic Rash – Extremely itchy, red, swollen bumps on the skin.
     

72. Cymbalta withdrawal - Pyrexia – Fever or the increase in body temperature that is usually a sign of infection.
     

73. Cymbalta withdrawal - Retinal Detachment – The thin layer lining the back of the eyeball (the retina) detaches from the back of the eyeball.  This thin layer is like the film of a camera because it sends the images a person views to the brain.  When it detaches it causes a reduced ability to see.
     

74. Cymbalta withdrawal - Rigors – Shivering or shaking of the body as if chilled, preventing normal responses.
     

75. Cymbalta withdrawal - Skin Ulcer – An open sore or infected skin eruption with swelling, redness, pus, and irritation.
     

76. Cymbalta withdrawal - Sleep Disorder – These are a list of sleep disorders such as teeth grinding, insomnia, jet lag, sleep walking, abnormally falling asleep during the middle of a conversation after a full night’s rest, uncontrolled body motions keeping one awake, etc.
     
77. Cymbalta withdrawal - Suicide, Completed – An attempted attack on oneself that is life threatening results in death.
     

78. Cymbalta withdrawal - Upper Respiratory Tract Infection – Where the organs of breathing near the mouth such as the nose and sinuses, become infected and are usually treated by antibiotics.
     

79. Cymbalta withdrawal - Urinary Hesitation – Hard to start or hard to continue emptying one’s bladder.
     

80. Cymbalta withdrawal - Urinary Incontinence – Urinating without intending to do so because of a weakening of the muscles in the hip area from the drug affecting the nerves or the drug blocking a persons thinking process.
     

81. Cymbalta withdrawal - Urinary Retention – The inability to completely empty the bladder despite having the urge to do so.  This can lead to infections or damage to the urinary organs.
     

82. Cymbalta withdrawal - Urine Flow Decreased – Dehydration of the body causing a lesser flow of urine than normal with the body reabsorbing the waste.
     

83. Cymbalta withdrawal - Urine Output Decreased – A condition where the output of urine produced in a 24-hour period is less than 500 ml.
     

84. Cymbalta withdrawal - Weight Decreased – Unintentional weight loss.
     
85. Cymbalta withdrawal – Weight Increased – An unusual, usually rapid weight increase.

Cymbalta withdrawal. How to avoid Cymbalta withdrawal side effects click here

Pharmacokinetics

  CYMBALTA has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics are dose proportional over the therapeutic range. Steady-state plasma concentrations are typically achieved after 3 days of dosing. Elimination of CYMBALTA is mainly through hepatic metabolism involving two P450 isozymes, CYP2D6 and CYP1A2.

  Absorption and Distribution – Orally administered CYMBALTA is well absorbed. There is a median 2-hour lag until absorption begins (T lag), with maximal plasma concentrations C max) of CYMBALTA occurring 6 hours post dose. Food does not affect the Cmax of CYMBALTA, but delays the time to reach peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (AUC) by about 10%. There is a 3-hour delay in absorption and a one-third increase in apparent clearance of CYMBALTA after an evening dose as compared to a morning dose.

  The apparent volume of distribution averages about 1640 L. CYMBALTA is highly bound (>90%) to proteins in human plasma, binding primarily to albumin and ą1-acid glycoptrotein. Plasma protein binding of CYMBALTA is not affected by renal or hepatic impairment.

  Metabolism and Elimination – Biotransformation and disposition of CYMBALTA in humans have been determined following oral administration of 14C-labeled CYMBALTA. CYMBALTA comprises about 3% of the total radiolabeled material in the plasma, indication that it undergoes extensive metabolism to numerous metabolites. The major biotransformation pathways for CYMBALTA involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP2D6 and CYP1A2 catalyze the oxidation of the naphthyl ring in vitro.   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. Only trace (1% of the dose) amounts of unchanged CYMBALTA are present in the urine. Most (about 70%) of the CYMBALTA dose appears I the urine as metabolites of CYMBALTA; about 20% is excreted in the feces.

  Smoking Status – CYMBALTA bioavailability (AUC) appears to be reduced by about one-third in smokers. Dosage modifications are not recommended for smokers. Back to top of page

  Race – No specific pharmacokinetic study was conducted to investigate the effects of race.

  Renal Insufficiency – Limited data are available on the effects of CYMBALTA in patients with end stage renal disease (ESRD). After a single 60-mg dose of CYMBALTA, Cmax and AUC values were approximately 100% greater inpatients with end stage renal disease receiving chronic intermittent hemodialysis than in subjects with normal renal fuction. The elimination half-life, however, was similar in both groups. The AUC’s of the major circulation metabolites, 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate, largely excreted in urine, were approximately 7 – to 9 – fold higher and would be expected to increase further with multiple dosing. For this reason, CYMBALTA is not recommended for patients with ESRD (see DOSAGE AND ADMINISTATION). Studies have not been conducted in patients with a moderate degree of renal dysfunction, but population PK analyses suggest that mild renal dysfunction has no significant effect on CYMBALTA apparent clearance.

Hepatic Insufficiency – Patients with clinically evident hepatic insufficiency have decreased CYMBALTA metabolism and elimination. After a single 20-mg dose of CYMBALTA 6 cirrhotic patients with moderate liver impairment (Child-Pugh Class B) had a mean plasma CYMBALTA clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (AUC). Although Cmax was similar to normals in the cirrhotic patients, the half-life was about 3 times longer (see PRECAUTIONS). It is recommended that CYMBALTA no be administered to patients with any hepatic insufficiency (see DOSAGE AND ADMINISTRATION).   Back to top of page

Drug-Drug Interactions (also see PRECAUTIONS, Drug Interactions)

Potential for Other Drugs to Affect CYMBALTA.

  Both CYP1A2 and CYP2D6 are responsible for CYMBALTA metabolism.

INDICATIONS AND USAGE

CYMBALTA is indicated for the treatment of major depressive disorder (MDD).

CONTRAINDICATIONS

Hypersensitivity

CYMBALTA is contraindicated in patients with a known hypersensitivity to the product.

WARNINGS Back to top of page

  Clinical Worsening and Suicide Risk – Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there was been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases of decreases.  Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or whose emergent suicidality is severe, abrupt in onset, or was not part of the patient’s presenting symptoms.

  Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and nonpsychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric and nonpsychiatric disorders.

  The following symptoms – anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania – have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medications, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

  Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of suicidality, and to report such symptoms immediately to health care providers. Prescriptions for CYMBALTA should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.

  If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION, Discontinuing CYMBALTA (duloxetine hydrochloride), for a description  of the risks of discontinuation of CYMBALTA).

Information of Patients Back to top of page

  Physicians are advised to discuss the following issues with patients for whom they prescribe CYMBALTA.

  Patients and their families should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression, and suicidal ideation, especially early during antidepressant treatment. Such symptoms should be reported to the patient’s physician, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

  Any psychoactive drug may impair judgment, thinking, or motor skills.

Drug Interactions (also see CLINICAL PHARMACOLOGY, Drug – Drug

Interactions)

  Inhibitors of CYP2D6 – Because CYP2D6 is involved in CYMBALTA metabolism, concomitant use of CYMBALTA with potent inhibitors of CYP2D6 may result in higher concentrations of CYMBALTA. Paroxetine (20 mg QD) increased the concentration of CYMBALTA (40 mg QD) by about 60%, and greater degrees of inhibition are expected with higher doses of Paroxetine. Similar effect would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine).

 ADVERSE REACTIONS Back to top of page

  CYMBALTA has been evaluated for safety in 2418 patients diagnosed with major depressive disorder who participated in multiple-dose premarketing trials, representing 1099 patient-years of exposure. Among these 2418 CYMBALTA treated patients, 1139 patients participated in eight 8- or 9- week, placebo-controlled trials at doses ranging from 40 to 120 mg/day, while the remaining 1279 patients were followed for up to 1 year in an open-label safety study using flexible doses from 80 to 120 mg/day. Two placebo-controlled studies with doses of 80 to 120 mg/day had 6- month maintenance extensions. Of these 2418 patients, 993 CYMBALTA-treated patients were exposed for at least 180 days and 445 CYMBALTA-treated patients were exposed for at least 1 year. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

  Clinical investigators recorded adverse events using descriptive terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing adverse events, grouping similar types of events into a smaller number of standardized event categories is necessary. In the tables and tabulations that follow, MedDRA terminology has been used to classify reported adverse events.

  The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Events reported during the studies were not necessarily caused by the therapy, and the frequencies do not reflect investigator impression (assessment) of causality.

  The cited figures provide the prescriber with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.

Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials

  Approximately 10% of the 1139 patients who received CYMBALTA in the placebo-controlled trials discontinued treatment due to an adverse event, compared with 4% of the 777 patients receiving placebo. Nausea (CYMBALTA 1.4%, placebo 0.1%) was the only common adverse event reported as reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the CYMBALTA-treated patients and at a rate of at least twice that of placebo).

Adverse Events Occurring at an Incidence of 2% or More Among CYMBALTA-Treated Patients in Placebo-Controlled Trials Back to top of page

  Table 1 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with CYMBALTA in the acute phase of MDD placebo-controlled trials and with an incidence greater than placebo. The most commonly observed adverse events in CYMBALTA-treated MDD patients (incidence of 5% or greater and at least twice the incidence in placebo patients) were nausea; dry mouth; constipation; decreased appetite; fatigue; somnolence; and increased sweating.

Effects on Male and Female Sexual Function

  Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.

Other Adverse Events Observed During the Premarketing Evaluation of CYMBALTA

  Following is a list of modified MedDRA terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with CYMBALTA at multiple doses throughout the dose range studied during any phase of a trial within the premarketing database. The events included are those not already listed elsewhere in ADVERSE REACTIONS and not considered in the WARNINGS and PRECAUTIONS sections, that were reported with an incidence of greater than or equal to 0.05%, are not common as background events and were considered possibly drug related (e.g., because of the drug’s pharmacology) or potentially important. Back to top of page

  It is important to emphasize that, although the events reported occurred during treatment with CYMBALTA, they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

  Blood and Lymphatic System Disorders – Infrequent: anemia, leukopenia, increased whit blood cell count, lymphadenopathy, and thrombocytopenia.

  Gastrointestinal Disorders – Frequent: gastritis: Infrequent: blood in stool, colitis, dysphagia, esophageal stenosis acquired, gastric ulcer, gingivitis, irritable bowel syndrome, and lower abdominal pain.

  Psychiatric Disorders – Frequent: initial insomnia, irritability, lethargy, nervousness, nightmare, restlessness, and sleep disorder; Infrequent: completed suicide, mania, mood swings, pressure of speech, sluggishness, and suicide attempt.

  Renal and Urinary Disorders – Frequent: dysuria; infrequent: micturition urgency, urinary hesitation, urinary incontinence, urinary retention, and urine flow decreased.

  Skin and Subcutaneous Tissue Disorders – Frequent: night swats, pruritus, and rash; Infrequent: acne, alopecia, cold sweat, ecchymosis, eczema, erythema, face edema, increased tendency to bruise, and photosensitivity reaction.

  Vascular Disorders – Infrequent: peripheral edema and phlebitis.

Discontinuing CYMBALTA (duloxetine hydrochloride) Back to top of page

  Symptoms associated with discontinuation of CYMBALTA and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

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