Fluoxetine / olanzapine Side Effects

Not all side effects for fluoxetine / olanzapine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fluoxetine / olanzapine: oral capsule

In addition to its needed effects, some unwanted effects may be caused by fluoxetine / olanzapine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking fluoxetine / olanzapine:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • confusion
  • congestion
  • cough
  • delusions
  • dementia
  • dryness or soreness of the throat
  • fever
  • hoarseness
  • rapid weight gain
  • runny nose
  • shakiness in the legs, arms, hands, or feet
  • tender, swollen glands in the neck
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • trouble with swallowing
  • unusual weight gain or loss
  • voice changes
Less common
  • Blurred vision
  • change in personality
  • change in vision
  • difficult or labored breathing
  • difficulty with sleeping
  • difficulty with speaking
  • dizziness
  • ear pain
  • headache
  • impaired vision
  • increase in body movements
  • loss of memory
  • nervousness
  • pounding in the ears
  • problems with memory
  • slow, fast, pounding, or irregular heartbeat or pulse
  • tightness in the chest
Rare
  • Inability to move the eyes
  • increased blinking or spasms of the eyelid
  • sticking out of the tongue
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions
Incidence not known
  • Bloody or black, tarry stools
  • constipation
  • severe stomach pain
  • vomiting of blood or material that looks like coffee grounds

Some of the side effects that can occur with fluoxetine / olanzapine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • dry mouth
  • increased appetite
  • lack or loss of strength
  • weight gain
Less common
  • Change or problem with discharge of semen
  • decreased interest in sexual intercourse
  • difficulty with moving
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • muscle pain or stiffness
  • not able to have an orgasm
  • pain, swelling, or redness in the joints
  • tooth disorder
  • twitching

For Healthcare Professionals

Applies to fluoxetine / olanzapine: oral capsule

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. Bruxism and headache have 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. Diabetic coma has 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. Esophageal ulcer has also been reported.

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, oliguria, 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. Gynecological bleeding has been reported. Additional findings observed in clinical studies have included decreased libido, anorgasmia, erectile dysfunction and abnormal ejaculation.

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

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. Eosinophilic pneumonia has been reported.

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.

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 QT interval, ventricular arrhythmia including Torsade de Pointes, 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, thrombocythemia, neutropenia, and agranulocytosis have been reported infrequently. Bleeding episodes in patients treated with psychotropic drugs that interfere with serotonin reuptake have also been reported. Aplastic anemia has been reported.

Endocrine

Endocrine side effects have rarely included hypothyroidism and hyperprolactinemia.

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. Cholestatic jaundice has also been reported.

Dermatologic

Dermatologic side effects have included acne, alopecia, contact dermatitis, dry skin, eczema, pruritus, psoriasis, skin discoloration, vesiculobullous rash, exfoliative dermatitis, maculopapular rash, seborrhea, and skin ulcer. Erythema multiforme and sweating have also been reported.

Psychiatric

Psychiatric side effects have included intentional overdose, suicide attempt, abnormal thinking, and personality disorder. Violent behaviors have also been reported.

General

General side effects have included sudden unexpected death.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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