Sertraline is a serotonin reuptake inhibitor sold in the U.S. under 2 brand and generic names, for feeding and eating disorders, depressive disorder and obsessive-compulsive disorder. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Sertraline Hydrochloride (application ANDA214790). Other sertraline products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Indication Starting Dosage Maximum Dosage MDD (2.1) 50 mg per day 200 mg per day OCD (2.1) 25 mg per day (ages 6-12) 50 mg per day (ages ≥13 ) 200 mg per day PD, PTSD, SAD (2.1) 25 mg per day 200 mg per day PMDD (2.2) continuous dosing 50 mg per day 150 mg per day PMDD (2.2) intermittent dosing 50 mg per day during luteal phase only 100 mg per day during luteal phase only If inadequate response to starting dosage, titrate in 25-50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD (2.1) See Full Prescribing Information for titration in PMDD (2.2) Hepatic impairment: Mild: Recommended starting and maximum dosage is half recommended dosage (2.4) Moderate or severe: Not recommended (2.4) When discontinuing sertraline hydrochloride, reduce dose gradually (2.6, 5.4) 2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage. For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one…
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications (4)] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4), Clinical Pharmacology (12.2)] Suicidal thoughts and behaviors [See Warnings and Precautions (5.1)] Serotonin syndrome [See Contraindications (4), Warnings and Precautions (5.2), Drug Interactions (7.1)] Increased risk of bleeding [See Warnings and Precautions (5.3)] Activation of mania/hypomania [See Warnings and Precautions (5.4)] Discontinuation syndrome [See Warnings and Precautions (5.5)] Seizures [See Warnings and Precautions (5.6)] Angle-closure glaucoma [See Warnings and Precautions (5.7)] Hyponatremia [See Warnings and Precautions (5.8)] Sexual Dysfunction [See Warnings and Precautions (5.11)] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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| 1 | 70/100 | Prescription | Capsule | Generic | $1 | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| A;1;6 | 25 mg | green | capsule | — |
| G;74 | 25 mg | green | capsule | — |
| S3 | 100 mg | yellow | round | — |
| A;1;8 | 100 mg | yellow | capsule | — |
| 212;IG | 25 mg | green | oval | — |
| 213;IG | 50 mg | blue |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
The elimination half-life of sertraline is about 26 hours. This is the parent drug's terminal elimination half-life; its main metabolite, N-desmethylsertraline, lingers much longer (62 to 104 hours) but is substantially less active than sertraline. Elimination is slower in older adults (clearance about 40% lower), so levels can build up more.
SERTRALINE HYDROCHLORIDE tablet - DailyMed (FDA label, Clinical Pharmacology / Pharmacokinetics) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Sertraline hydrochloride is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] . Taking pimozide [See Drug Interactions (7.1)] . With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2)]. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4, 7.1) Concomitant use of pimozide (4, 7.1) Known hypersensitivity to sertraline or excipients (4, 5.4)
Protein-bound drugs: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs (e.g., warfarin) as warranted. (7.1, 12.3) CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6. (7.1, 12.3) 7.1 Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with sertraline hydrochloride [See Clinical Pharmacology (12.3)] . Table 5. Clinically-Significant Drug Interactions with Sertraline Hydrochloride Monoamine Oxidase Inhibitors (MAOIs) linical Impact: The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome. Intervention: Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See Dosage and Administration (2.5), Contraindications (4), Warnings and Precautions (5.2)]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and sertraline hydrochloride is contraindicated [See Contraindications (4)]. Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs with sertraline…
| 68/100 |
| Prescription |
| Solution |
| Generic |
| $1 |
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| oval |
| — |
| 214;IG | 100 mg | yellow | oval | — |
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