Symbyax 6mg/25mg Capsule
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Indications & Clinical Uses
- Symbyax (olanzapine/fluoxetine) has been discontinued by Eli Lilly in the United States — all brand-name strengths are listed as discontinued, and no generic olanzapine/fluoxetine combination capsule has been approved to replace it, so Symbyax is not currently available to be dispensed under this brand name; this is a manufacturer/commercial discontinuation, not a formal FDA withdrawal of approval, and the underlying FDA label remains on file.
- Where it was used, Symbyax combined olanzapine, an atypical antipsychotic, with fluoxetine, an SSRI antidepressant, in one capsule to treat depressive episodes associated with bipolar I disorder and treatment-resistant depression in adults who had already tried other antidepressants without success, and — at lower starting doses — in adolescents aged 10 to 17 with bipolar depression.
- Patients who still need this combination should discuss switching to olanzapine and fluoxetine prescribed and dosed separately.
Side Effects
- Common reactions historically reported include sedation/drowsiness, increased appetite and weight gain, dry mouth, tiredness, swelling (oedema), tremor, difficulty concentrating, and blurred vision; in children and adolescents, raised triglycerides and liver enzymes were also common.
- Symbyax carries TWO BOXED WARNINGS.
- First, antidepressants including the fluoxetine component increased the risk of suicidal thoughts and behaviour in children, adolescents, and young adults in clinical trials, and patients starting treatment should be watched closely for worsening mood or new suicidal thinking.
- Second, elderly patients with dementia-related psychosis treated with antipsychotic medicines like the olanzapine component are at increased risk of death, mainly from heart-related events or infections such as pneumonia; Symbyax is not approved for dementia-related psychosis.
- Rare but serious long-term risks include a movement disorder (tardive dyskinesia) that may not be reversible, and serotonin syndrome.
Precautions & Warnings
- Symbyax is contraindicated with monoamine oxidase inhibitors (MAOIs), and with pimozide or thioridazine because of dangerous heart rhythm interactions with the fluoxetine component.
- It should not be stopped suddenly; doses were tapered gradually to avoid antidepressant discontinuation symptoms.
- Regular monitoring of weight, blood sugar, and cholesterol/triglycerides was recommended because the olanzapine component can cause significant metabolic changes, including new-onset diabetes.
- Caution is needed in people with a personal or family history of seizures, liver or kidney impairment, or low white blood cell counts.
- Symbyax may impair alertness, so driving or operating machinery is not advised until effects are known.
- Use in pregnancy requires specialist discussion, since antipsychotics and SSRIs used late in pregnancy can affect the newborn.
- Symbyax was taken by mouth only, as capsules, usually once daily in the evening because of sedation.
Avoid Interactions
- Because Symbyax contains an SSRI (fluoxetine) that strongly inhibits the CYP2D6 liver enzyme, it can raise blood levels of many other drugs broken down by this pathway, including some antidepressants, antipsychotics, and heart-rhythm medicines.
- Combining Symbyax with other serotonergic medicines — other SSRIs/SNRIs, triptans, tramadol, or St John's Wort — increases the risk of serotonin syndrome, and MAOIs must never be combined, requiring a washout period of at least two weeks either side.
- Benzodiazepines and other central-nervous-system depressants, including alcohol, can add to Symbyax's sedative effect.
- Drugs that affect blood clotting, such as warfarin and aspirin, may have an increased bleeding effect when combined with fluoxetine.
- Always tell your prescriber about every medicine, supplement, and herbal product used.
References
Frequently Asked Questions
Symbyax combined olanzapine and fluoxetine in one capsule to treat depression linked to bipolar I disorder and treatment-resistant depression. The brand has been discontinued in the US, with no generic version available, so it can no longer be prescribed or dispensed under this name; ask your doctor about the individual medicines instead.
Symbyax was taken by mouth as one capsule daily, usually in the evening because it can cause drowsiness. Typical starting doses were olanzapine 6 mg with fluoxetine 25 mg, adjusted by a psychiatrist. Since it is discontinued, no one should start new treatment with this brand today.
Symbyax carries two boxed warnings. Antidepressants like its fluoxetine component can increase suicidal thoughts in children, adolescents, and young adults. Antipsychotics like its olanzapine component increase the risk of death in elderly patients with dementia-related psychosis. Symbyax was never approved for dementia-related psychosis.
Never combine Symbyax with an MAOI, pimozide, or thioridazine — these combinations are dangerous. Avoid other serotonergic drugs, such as SSRIs, triptans, or St John's Wort, due to serotonin syndrome risk, and limit alcohol because it adds to drowsiness. Do not stop Symbyax abruptly; doses were tapered gradually.
Eli Lilly discontinued all brand-name strengths of Symbyax commercially in the US; this was a manufacturer decision, not an FDA safety withdrawal, and no generic replacement has been approved. Patients previously on Symbyax should talk to their psychiatrist about switching to separately dosed olanzapine and fluoxetine.
Symbyax was approved for bipolar depression in adolescents aged 10 to 17, starting at lower doses than in adults, with close monitoring for suicidal thoughts. It was not approved for children under 10. As the brand is now discontinued, this option is no longer available.

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