Symbyax Side Effects

Please note - some side effects for Symbyax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Symbyax - for the Consumer

Symbyax

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Symbyax:

Blurred vision; constipation; decreased sexual desire or ability; dizziness; drowsiness; diarrhea; dry mouth; increased appetite; sore throat; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; joint pain; memory loss; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well being, restlessness, or inability to sit still; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, headache, or trouble sleeping; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of dehydration (eg, decreased sweating or urination, severe or persistent dry mouth, feeling very hot or thirsty); symptoms of stroke (eg, one-sided weakness, slurred speech); tremor; trouble concentrating, speaking, swallowing, or walking; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling, hoarseness, or sweating; unusual weakness; vision changes; worsening of depression.

Symbyax Side Effects - for the Professional

Symbyax

Most common adverse reactions (≥5% and at least twice that for placebo) are disturbance in attention, dry mouth, fatigue, hypersomnia, increased appetite, peripheral edema, sedation, somnolence, tremor, vision blurred, and weight increased (6.1)

Side Effects by Body System

Nervous system

Nervous system side effects have frequently included somnolence (up to 22%), tremor (up to 9%), abnormal thinking (6%), decreased libido (up to 4%), amnesia (up to 3%), hyperkinesia (up to 2%), personality disorder (up to 2%), and sleep disorder (up to 2%). Seizures, abnormal gait, ataxia, buccoglossal syndrome, cogwheel rigidity, coma, confusion, depersonalization, dysarthria, emotional lability, euphoria, extrapyramidal syndrome, hostility, hypesthesia, hypokinesia, incoordination, movement disorder, myoclonus, neuralgia, neurosis, vertigo, acute brain syndrome, aphasia, dystonia, increased libido, subarachnoid hemorrhage, and withdrawal syndrome have also been reported.

Metabolic

Fourteen percent of fluoxetine-olanzapine treated patients met criteria for having gained greater than 10% of their baseline weight.

Metabolic side effects have frequently included weight gain (up to 21%), peripheral edema (up to 8%), edema (up to 5%), and weight loss. Alcohol intolerance, dehydration, glycosuria, hyperlipemia, hypoglycemia, hypokalemia, obesity, acidosis, bilirubinemia, increased creatinine, gout, hyperkalemia, and hypoglycemic reaction have also been reported.

Gastrointestinal

Gastrointestinal side effects have frequently included diarrhea (up to 19%), dry mouth (up to 16%), increased appetite (up to 16%), tooth disorder (up to 2%), increased salivation, and thirst. Cholelithiasis, colitis, eructation, esophagitis, gastritis, gastroenteritis, gingivitis, nausea, vomiting, peptic ulcer, periodontal abscess, stomatitis, tooth caries, aphthous stomatitis, fecal incontinence, gastrointestinal hemorrhage, taste perversion, intestinal obstruction, and pancreatitis have also been reported. Dysphagia has been reported infrequently.

Genitourinary

Genitourinary side effects have frequently included abnormal ejaculation (up to 7%), impotence (up to 4%), anorgasmia (up to 3%), breast pain, menorrhagia, urinary frequency, urinary incontinence, and urinary tract infection. Amenorrhea, breast enlargement, breast neoplasm, cystitis, dysuria, female lactation, fibrocystic breast, hematuria, hypomenorrhea, leukorrhea, menopause, metrorrhagia, oliguris, ovarian disorder, polyuria, urinary retention, urinary urgency, impaired urination, vaginal hemorrhage, vaginal moniliasis, and vaginitis have been reported infrequently. Breast carcinoma, breast engorgement, endometrial disorder, gynecomastia, kidney calculus, and enlarged uterine fibroids have also been reported.

Musculoskeletal

Musculoskeletal side effects have frequently included twitching (up to 6%), arthralgia (up to 5%), and joint disorder (up to 2%). Arthritis, bone disorder, generalized spasm, leg cramps, tendinous contracture, tenosynovitis, arthrosis, bursitis, myasthenia, myopathy, osteoporosis, and rheumatoid arthritis have also been reported.

Respiratory

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although fluoxetine-olanzapine was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Fluoxetine-olanzapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Respiratory side effects have frequently included pharyngitis (up to 6%), dyspnea (up to 2%), bronchitis, and lung disorder. Apnea, asthma, epistaxis, hiccup, hyperventilation, laryngitis, pneumonia, voice alteration, yawn, emphysema, hemoptysis, and laryngismus have also been reported. An increased risk of mortality, possibly due to an infection, such as pneumonia, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

Ocular

Ocular side effects have frequently included amblyopia (up to 5%) and abnormal vision. Abnormality of accommodation, conjunctivitis, diplopia, dry eyes, eye pain, miosis, and eye hemorrhage have also been reported.

Cardiovascular

Cardiovascular side effects have frequently included hypertension (2%), tachycardia (2%), bradycardia, orthostatic hypotension, and vasodilatation. Arrhythmia, cerebral ischemia, abnormal electrocardiogram, hypotension, prolongation of Q-T interval, anginal pectoris, atrial arrhythmia, atrial fibrillation, bundle branch block, congestive heart failure, myocardial infarction, peripheral vascular disorder, and inverted T-wave have also been reported. An increased risk of mortality, possibly due to heart failure or sudden death, has been reported with the use of atypical antipsychotic agents in the treatment of behavioral disorders in the elderly patient with dementia.

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although fluoxetine-olanzapine was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Fluoxetine-olanzapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

The mean increase in QTc interval for fluoxetine-olanzapine treated patients was significantly greater than that for placebo treated patients or patients treated with olanzapine alone. It was not significantly different from patients treated with fluoxetine alone.

The mean pulse of fluoxetine-olanzapine treated patients has been reported to have been reduced by 1.6 beats per minute.

Other

Other side effects have frequently included asthenia (up to 15%), accidental injury (up to 5%), fever (up to 4 %), ear pain (up to 2%), otitis media (2%), speech disorder (up to 2%), tinnitus, chills, infection, neck pain, neck rigidity, and photosensitivity reaction. Deafness, cellulitis, cyst, hernia, intentional injury, intentional overdose, malaise, moniliasis, overdose, pelvic pain, suicide attempt, death, and decreased tolerance have also been reported. Discontinuation of treatment has been associated with somnolence (up to 2%), weight gain (up to 2%), asthenia (up to 1%), and chest pain (up to 1%). Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic drugs.

Hematologic

Hematologic side effects have frequently included ecchymosis. Anemia, leukocytosis, lymphadenopathy, coagulation disorder, leukopenia, purpura, and thrombocythemia have been reported infrequently. Bleeding episodes in patients treated with psychotropic drugs that interfere with serotonin reuptake have also been reported.

Endocrine

Endocrine side effects have rarely included hypothyroidism and elevated prolactin levels.

Hepatic

Hepatic side effects have included hepatomegaly, liver fatty deposit, asymptomatic elevations of hepatic transaminases ALT (SGPT), AST (SGOT), and GGT, and asymptomatic elevations in alkaline phosphatase.

Dermatologic

Dermatologic side effects have included acne, alopecia, contact dermatitis, dry skin, eczema, pruritis, psoriasis, skin discoloration, vesiculobullous rash, exfoliative dermatitis, maculopapular rash, seborrhea, and skin ulcer.

Psychiatric

Psychiatric side effects have included intentional overdose, suicide attempt, abnormal thinking, and personality disorder.

General

General

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