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This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.
Description, Dosage, Side Effects, Contraindications. Data from EMA, URPL, openFDA and other regulatory sources.
| Fluoxetine | Sertraline | |
|---|---|---|
| Active Substances | FLUOXETINE | Sertralinum |
| ATC Code | N06AB03 | N06AB06 |
| Form | TABLET | Tabletki powlekane |
| Dosage | 60 mg/1 | 100 mg |
| Route | ORAL | doustna |
| Manufacturer | Strides Pharma Science Limited | Zentiva, k.s. |
| Indications | This medication is an antidepressant, prescribed for depression and anxiety. It is also used for obesity and eating disorders. | Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years. Social anxiety disorder. Post traumatic stress disorder (PTSD). |
| Side Effects | Body as a Whole - Headache, weakness, flu syndrome and fever. Heart - Dilatation of blood vessels. Gastrointestinal - Nausea, diarrhea, loss of appetite, dry mouth, indigestion, constipation, flatulence and vomiting. Metabolic - Weight loss. Central Nervous System - Sleeplessness, nervousness, anxiety, drowsiness, dizziness, tremor, decreased sexual interest and abnormal thinking. Respiratory - Yawn. Skin - Increased sweating, rash and itching. Special Senses - Abnormal vision. |
Fluoxetine (INN: FLUOXETINE, ATC N06AB03) and Sertraline (INN: Sertralinum, ATC N06AB06) differ in active substance, indications, and safety profile. The table above summarizes the clinical differences from regulatory documents.
Combination safety depends on mechanisms and your health profile. Use our interactions checker and always consult your doctor or pharmacist before combining medications.
Both drugs are approved when used per label. Safety is patient-specific — the better choice depends on your condition, other medications, allergies, and comorbidities. Consult a healthcare professional for personalized advice.
This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.
| Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo. These undesirable effects are dose dependent and are often transient in nature with continued treatment. The undesirable effects profile commonly observed in double-blind, placebo-controlled studies in patients with OCD, panic disorder, PTSD and social anxiety disorder was similar to that observed in clinical trials in patients with depression. Table 1 displays adverse reactions observed from post-marketing experience (frequency not known) and placebo-controlled clinical trials (comprising a total of 2542 patients on sertraline and 2145 on placebo) in depression, OCD, panic disorder, PTSD and social anxiety disorder. Some adverse drug reactions listed in Table 1 may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy. Table 1: Adverse Reactions Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience. System Organ Class Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Frequency Not Known (Cannot be Estimated From the Available Data) Infections and infestations upper respiratory tract infection, pharyngitis, rhinitis gastroenteritis, otitis media diverticulitis § Neoplasms benign, malignant and unspecified (including cysts and polyps) neoplasm Blood and lymphatic system disorders lymphadenopathy, thrombocytopenia ∗§ , leukopenia ∗§ Immune system disorders hypersensitivity ∗ , seasonal allergy ∗ anaphylactoid reaction ∗ Endocrine disorders hypothyroidism ∗ hyperprolactinaemia ∗§ , inappropriate antidiuretic hormone secretion ∗§ Metabolism and nutrition disorders decreased appetite, increased appetite ∗ hypercholesterolaemia, diabetes mellitus ∗ , hypoglycaemia ∗ , hyperglycaemia ∗§ , hyponatraemia ∗§ Psychiatric disorders insomnia anxiety * , depression * , agitation * , libido decreased * , nervousness, depersonalisation, nightmare, bruxism * suicidal ideation/behaviour, psychotic disorder ∗ , thinking abnormal, apathy, hallucination * , aggression * , euphoric mood * , paranoia conversion disorder ∗§ , paroniria ∗§ , drug dependence, sleep walking, premature ejaculation Nervous system disorders dizziness, headache *, somnolence tremor, movement disorders (including extrapyramidal symptoms such as hyperkinesia, hypertonia, dystonia, teeth grinding or gait abnormalities), paraesthesia * , hypertonia * , disturbance in attention, dysgeusia amnesia, hypoaesthesia * , muscle contractions involuntary * , syncope * , hyperkinesia * , migraine * , convulsion * , dizziness postural, coordination abnormal, speech disorder coma * , akathisia (see section 4.4), dyskinesia, hyperaesthesia, cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome) ∗§ , psychomotor restlessness ∗§ (see section 4.4), sensory disturbance, choreoathetosis § , also reported were signs and symptoms associated with serotonin syndrome ∗ or neuroleptic malignant syndrome: In some cases associated with concomitant use of serotonergic drugs that included agitation, confusion, diaphoresis, diarrhoea, fever, hypertension, rigidity and tachycardia § Eye disorders visual disturbance ∗ mydriasis ∗ scotoma, glaucoma, diplopia, photophobia, hyphaema ∗§ , pupils unequal ∗§ , vision abnormal § , lacrimal disorder maculopathy Ear and labyrinth disorders tinnitus ∗ ear pain Cardiac disorders palpitations ∗ tachycardia ∗ , cardiac disorder myocardial infarction ∗§ , Torsade de Pointes ∗§ (see sections 4.4, 4.5 and 5.1), bradycardia, QTc prolongation ∗ (see sections 4.4, 4.5 and 5.1) Vascular disorders hot flush ∗ abnormal bleeding (such as gastrointestinal bleeding) ∗ , hypertension ∗ , flushing, haematuria ∗ peripheral ischaemia Respiratory, thoracic and mediastinal disorders yawning ∗ dyspnoea, epistaxis ∗ , bronchospasm * hyperventilation, interstitial lung disease ∗§ , eosinophilic pneumonia*§, laryngospasm, dysphonia, stridor ∗§ , hypoventilation, hiccups Gastrointestinal disorders nausea, diarrhoea, dry mouth dyspepsia, constipation * , abdominal pain * , vomiting * , flatulence melaena, tooth disorder, oesophagitis, glossitis, haemorrhoids, salivary hypersecretion, dysphagia, eructation, tongue disorder mouth ulceration, pancreatitis ∗§ , haematochezia, tongue ulceration, stomatitis colitis microscopic* Hepatobiliary disorders hepatic function abnormal, serious liver events (including hepatitis, jaundice and hepatic failure) Skin and subcutaneous tissue disorders hyperhidrosis, rash * periorbital oedema * , urticaria * , alopecia * , pruritus * , purpura * , dermatitis, dry skin, face oedema, cold sweat rare reports of severe cutaneous adverse reactions (SCAR): e.g. Stevens-Johnson syndrome ∗ and epidermal necrolysis ∗§ , skin reaction ∗§ , photosensitivity § , angioedema, hair texture abnormal, skin odour abnormal, dermatitis bullous, rash follicular Musculoskeletal and connective tissue disorders back pain, arthralgia ∗ , myalgia osteoarthritis, muscle twitching, muscle cramps ∗ , muscular weakness rhabdomyolysis ∗§ , bone disorder trismus *, Multiple acyl-coenzyme A dehydrogenase deficiency (MADD)-like disorder* Renal and urinary disorders pollakiuria, micturition disorder, urinary retention, urinary incontinence * , polyuria, nocturia urinary hesitation * , oliguria Reproductive system and breast disorders ejaculation failure menstruation irregular ∗ , erectile dysfunction sexual dysfunction (see section 4.4), menorrhagia, vaginal haemorrhage, female sexual dysfunction (see section 4.4) galactorrhoea * , atrophic vulvovaginitis, genital discharge, balanoposthitis ∗§ , gynaecomastia ∗ , priapism * postpartum haemorrhage *† General disorders and administration site conditions fatigue * malaise * , chest pain * , asthenia ∗ , pyrexia ∗ oedema peripheral * , chills, gait disturbance ∗ , thirst hernia, drug tolerance decreased Investigations weight increased ∗ alanine aminotransferase increased * , aspartate aminotransferase increased * , weight decreased * blood cholesterol increased ∗ , abnormal clinical laboratory results, semen abnormal, altered platelet function ∗§ Injury, poisoning and procedural complications injury Surgical and medical procedures vasodilation procedure ∗ ADR identified post-marketing § ADR frequency represented by the estimated upper limit of the 95% confidence interval using “The Rule of 3”. † This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6). Withdrawal symptoms seen on discontinuation of sertraline treatment Discontinuation of sertraline (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported. Generally these events are mild to moderate and are self-limiting; however, in some patients they may be severe and/or prolonged. It is therefore advised that when sertraline treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4). Elderly population SSRIs or SNRIs including sertraline have been associated with cases of clinically significant hyponatraemia in elderly patients, who may be at greater risk for this adverse event (see section 4.4). Paediatric population In over 600 paediatric patients treated with sertraline, the overall profile of adverse reactions was generally similar to that seen in adult studies. The following adverse reactions were reported from controlled trials (n=281 patients treated with sertraline): Very common (≥1/10) : Headache (22%), insomnia (21%), diarrhoea (11%) and nausea (15%). Common (≥1/100 to <1/10) : Chest pain, mania, pyrexia, vomiting, anorexia, affect lability, aggression, agitation, nervousness, disturbance in attention, dizziness, hyperkinesia, migraine, somnolence, tremor, visual disturbance, dry mouth, dyspepsia, nightmare, fatigue, urinary incontinence, rash, acne, epistaxis, flatulence. Uncommon (≥1/1000 to <1/100) : ECG QT prolonged (see sections 4.4, 4.5 and 5.1), suicide attempt, convulsion, extrapyramidal disorder, paraesthesia, depression, hallucination, purpura, hyperventilation, anaemia, hepatic function abnormal, alanine aminotransferase increased, cystitis, herpes simplex, otitis externa, ear pain, eye pain, mydriasis, malaise, haematuria, rash pustular, rhinitis, injury, weight decreased, muscle twitching, abnormal dreams, apathy, albuminuria, pollakiuria, polyuria, breast pain, menstrual disorder, alopecia, dermatitis, skin disorder, skin odour abnormal, urticaria, bruxism, flushing. Frequency not known : enuresis Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. |
| Contraindications | — | Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia. Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see section 4.5). Concomitant intake of pimozide is contraindicated (see section 4.5). |
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| Warnings | • Caution should be exercised in patients with history of seizures, heart, liver or kidney problems, stomach bleeding, sugar, metabolic problems, suicidal thoughts, any allergy, who are taking other medications, elderly, children, during pregnancy and breast feeding. • It may cause drowsiness or dizziness, do not drive a car or operate machinery while taking this medication. • Avoid alcohol consumption. • It may develop increased risk of suicidal thoughts in children and teenagers; watch them carefully. • It may affect blood sugar level; monitor sugar level regularly while taking this medication. • Patient may develop with increased risk of neuroleptic malignant syndrome (NMS) with the following symptoms: fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat and sweating. If it is so consult with your doctor. ♦ Patient may develop with increased risk of Serotonin Syndrome with the following symptoms: agitation, confusion, hallucinations, coma, fever, irregular heartbeat, tremor, excessive sweating, nausea, vomiting, and diarrhea. | No special requirements. |
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