Formulary
Fluvoxamine maleate: Indications, Dosing, Side Effects and Interactions
For all selective serotonin re-uptake inhibitors Selectively inhibit the re-uptake of serotonin (5-hydroxytryptamine, 5-HT).
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Fluvoxamine maleate: Indications, Dosing, Side Effects and Interactions
For all selective serotonin re-uptake inhibitors Selectively inhibit the re-uptake of serotonin (5-hydroxytryptamine, 5-HT).
Drug action
For all selective serotonin re-uptake inhibitors Selectively inhibit the re-uptake of serotonin (5-hydroxytryptamine, 5-HT).
Indications and dose
**Depressive illness**
- **Adult** (By Mouth): Initially 50-100 mg daily, dose to be taken in the evening, dose to be increased gradually, increased if necessary up to 300 mg daily, doses over 150 mg daily are given in divided doses; maintenance 100 mg daily.
**Obsessive-compulsive disorder**
- **Adult** (By Mouth): Initially 50 mg daily, dose to be taken in the evening, dose is increased gradually if necessary after several weeks, increased if necessary up to 300 mg daily; maintenance 100-300 mg daily, doses over 150 mg daily are given in divided doses, if no improvement in obsessive-compulsive disorder within 10 weeks, treatment should be reconsidered.
**Obsessive-compulsive disorder for fluvoxamine maleate**
- **Child 8-17 years** (By mouth): Initially 25 mg daily, then increased in steps of 25 mg every 4-7 days (max. per dose 100 mg twice daily) if required, dose to be increased according to response, doses above 50 mg should be given in 2 divided doses, if no improvement in obsessive-compulsive disorder within 10 weeks, treatment should be reconsidered.
Cautions
For all selective serotonin re-uptake inhibitors Cardiac disease; concurrent electroconvulsive therapy; diabetes mellitus; epilepsy (discontinue if convulsions develop); history of bleeding disorders (especially gastro-intestinal bleeding); history of mania; susceptibility to angle-closure glaucoma Cautions, further information Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information): potentially inappropriate with current or recent significant hyponatraemia i.e. serum sodium less than 130 mmol/L (risk of exacerbating or precipitating hyponatraemia).
Contraindications
For all selective serotonin re-uptake inhibitors Poorly controlled epilepsy; SSRIs should not be used if the patient enters a manic phase
Side effects
For all selective serotonin re-uptake inhibitors Common or very common Anxiety; appetite abnormal; arrhythmias; arthralgia; asthenia; concentration impaired; confusion; constipation; depersonalisation; diarrhoea; dizziness; drowsiness; dry mouth; fever; gastrointestinal discomfort; haemorrhage; headache; hyperhidrosis; malaise; memory loss; menstrual cycle irregularities; myalgia; mydriasis; nausea (dose-related); palpitations; paraesthesia; QT interval prolongation; sexual dysfunction; skin reactions; sleep disorders; taste altered; tinnitus; tremor; urinary disorders; visual impairment; vomiting; weight changes; yawning Uncommon Alopecia; angioedema; behaviour abnormal; hallucination; leucopenia; mania; movement disorders; photosensitivity reaction; postural hypotension; seizure; suicidal behaviours; syncope Rare or very rare Galactorrhoea; hepatitis; hyperprolactinaemia; hyponatraemia; serotonin syndrome; severe cutaneous adverse reactions (SCARs); SIADH; thrombocytopenia Frequency not known Increased risk of fracture; withdrawal syndrome Side-effects, further information Symptoms of sexual dysfunction may persist after treatment has stopped. Overdose Symptoms of poisoning by selective serotonin re-uptake inhibitors include nausea, vomiting, agitation, tremor, nystagmus, drowsiness, and sinus tachycardia; convulsions may occur. Rarely, severe poisoning results in the serotonin syndrome, with marked neuropsychiatric effects, neuromuscular hyperactivity, and autonomic instability; hyperthermia, rhabdomyolysis, renal failure, and coagulopathies may develop. For details on the management of poisoning, see Selective serotonin re-uptake inhibitors, under Emergency treatment of poisoning . Side-effects For fluvoxamine maleate Rare or very rare Hepatic function abnormal (discontinue) Frequency not known Glaucoma; neuroleptic malignant-like syndrome (discontinue-potentially fatal); withdrawal syndrome neonatal
Interactions
**Severe interactions:**
- Fluvoxamine has been used in combination with lithium in the treatment of severely ill, drug-resistant patients.
- When given with fluvoxamine, warfarin plasma concentrations were significantly increased and prothrombin times prolonged.
**Other interactions (17):**
- Pharmacodynamic interactions The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents (including tramadol, buprenorphine,...
- However, lithium (and possibly also tryptophan) enhances the serotonergic effects of fluvoxamine.
- In patients on oral anticoagulants and fluvoxamine, the risk for haemorrhage may increase and these patients should therefore be closely monitored.
- As with other psychotropic drugs, patients should be advised to avoid alcohol use while taking fluvoxamine.
- Monoamine oxidase inhibitors Fluvoxamine should not be used in combination with MAOIs, including linezolid, due to risk of serotonin syndrome (see also section 4.3 and 4.4).
- Effect of fluvoxamine on the oxidative metabolism of other drugs Fluvoxamine can inhibit the metabolism of drugs metabolized by certain cytochrome P450 isoenzymes (CYPs).
Pregnancy
For all selective serotonin re-uptake inhibitors Specialist sources indicate SSRIs may be suitable for use in pregnancy, but the risks and benefits of use must be considered, and the lowest effective dose should be used. The available data regarding malformation risk for all SSRIs are conflicting and confounded, and a causal association between the use of SSRIs in pregnancy, and spontaneous miscarriage, preterm delivery, low birth weight, and adverse effects on infant neurodevelopment remains unconfirmed. Published data on first trimester use of fluoxetine and paroxetine are contradictory. Some studies suggest a small increased risk of cardiovascular malformations with the use of fluoxetine, and congenital malformations (particularly cardiovascular) with the use of paroxetine, however other studies do not support an association. There may be a small increased risk of persistent pulmonary hypertension in the newborn with the use of SSRIs beyond 20 weeks' gestation, and use in the later stages of pregnancy may result in neonatal withdrawal syndrome-neonates should be monitored for associated central nervous system, motor, respiratory, and gastro-intestinal symptoms. There may also be a small increased risk of postpartum haemorrhage when used in the month before delivery (see Important safety information ).
Breast feeding
For all selective serotonin re-uptake inhibitors Specialist sources indicate that sertraline and paroxetine are the SSRIs of choice in breast-feeding based on passage into milk, half-life, and published evidence of safety. However, all SSRIs can be used in breast-feeding with caution, and since there are risks with switching an SSRI, it may be more clinically appropriate to continue treatment with an SSRI that has been effective, or restart treatment with an SSRI that has previously been effective. With all SSRIs, infants should be monitored for drowsiness, poor feeding, adequate weight gain, gastro-intestinal disturbances, irritability, and restlessness. Breast feeding For fluvoxamine maleate Specialist sources indicate use with caution. Present in milk in small amounts; long half-life increases risk of accumulation in the infant.
Hepatic impairment
For all selective serotonin re-uptake inhibitors In general, manufacturers advise caution (prolonged half-life). Hepatic impairment For fluvoxamine maleate Dose adjustments Manufacturer advises low initial dose.
Renal impairment
Dose adjustments Start with a low dose. M
Medicinal forms
Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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