Formulary
Paroxetine: 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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Paroxetine: 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
**Major depression,Social anxiety disorder,Post-traumatic stress disorder,Generalised anxiety disorder**
- **Adult** (By Mouth): 20 mg daily, dose to be taken in the morning, no evidence of greater efficacy at higher doses; maximum 50 mg per day.
- **Elderly** (By Mouth): 20 mg daily, dose to be taken in the morning, no evidence of greater efficacy at higher doses; maximum 40 mg per day.
**Obsessive-compulsive disorder**
- **Adult** (By Mouth): Initially 20 mg daily, dose to be taken in the morning, increased in steps of 10 mg, dose to be increased gradually, increased to 40 mg daily, no evidence of greater efficacy at higher doses; maximum 60 mg per day.
- **Elderly** (By Mouth): Initially 20 mg daily, dose to be taken in the morning, increased in steps of 10 mg, dose to be increased gradually; maximum 40 mg per day.
**Panic disorder**
- **Adult** (By Mouth): Initially 10 mg daily, dose to be taken in the morning, increased in steps of 10 mg, dose to be increased gradually, increased to 40 mg daily, no evidence of greater efficacy at higher doses; maximum 60 mg per day.
- **Elderly** (By Mouth): Initially 10 mg daily, dose to be taken in the morning, increased in steps of 10 mg, dose to be increased gradually; maximum 40 mg per day.
**Menopausal symptoms, particularly hot flushes, in women with breast cancer (except those taking tamoxifen).**
- **Adult** (By Mouth): 10 mg once daily.
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). Cautions For paroxetine Achlorhydria; high gastric pH Cautions, further information Achlorhydria or high gastric pH Causes reduced absorption of the oral suspension.
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 paroxetine Common or very common Vision blurred Uncommon Diabetic control impaired Rare or very rare Acute glaucoma; hepatic disorders; peripheral oedema Frequency not known Colitis microscopic
Interactions
**Severe interactions:**
- Neuromuscular Blockers SSRIs may reduce plasma cholinesterase activity resulting in a prolongation of the neuromuscular blocking action of mivacurium and suxamethonium Fosamprenavir/ritonavir:...
- The plasma levels of fosamprenavir/ritonavir during co-administration of paroxetine were similar to reference values of other studies, indicating that paroxetine had no significant effect on...
- Procyclidine: Daily administration of paroxetine increases significantly the plasma levels of procyclidine.
**Other interactions (27):**
- Caution should be advised and a closer clinical monitoring is required when serotonergic drugs (such as L-tryptophan, triptans, tramadol, buprenorphine, linezolid, methylthioninium chloride...
- John's Wort - Hypericum perforatum - preparations) are combined with paroxetine.
- Caution is also advised with fentanyl used in general anaesthesia or in the treatment of chronic pain.
- Pimozide Increased pimozide levels of on average 2.5 times have been demonstrated in a study of a single low dose pimozide (2 mg) when co-administered with 60 mg paroxetine.
- This may be explained by the known CYP2D6 inhibitory properties of paroxetine.
- TdP) may be increased with concomitant use of other drugs which prolong the QTc interval (e.g.
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 paroxetine Specialist sources indicate can be used. 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 paroxetine Dose adjustments Manufacturer advises dose at the lower end of the range.
Renal impairment
Use with caution if creatinine clearance less than 30 mL/minute, M see Prescribing in renal impairment .
Medicinal forms
Solution,Tablet,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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