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Drug Safety-related Labeling Changes (SrLC)

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CELEXA (NDA-020822)

(CITALOPRAM HYDROBROMIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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02/04/2022 (SUPPL-41)

Approved Drug Label (PDF)

Boxed Warning

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WARNING: Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short- term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. CELEXA is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

4 Contraindications

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CELEXA is contraindicated in patients:

  • taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3), Drug Interactions (7)]. taking pimozide because of risk of QT prolongation [see Drug Interactions (7)].

  • with known hypersensitivity to citalopram or any of the inactive ingredients in CELEXA. Reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.2)].

5 Warnings and Precautions

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5.1 Behavior in Adolescents and Young Adults

5.2 QT-Prolongation and Torsade de Pointes

5.3 Serotonin Syndrome

5.4 Increased Risk of Bleeding

5.5 Activation of Mania or Hypomania

5.6 Discontinuation Syndrome

5.7 Seizures

5.8 Angle Closure Glaucoma

5.9 Hyponatremia

5.10 Sexual Dysfunction

6 Adverse Reactions

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The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hypersensitivity reactions [see Contraindications (4)]

  • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.1)]

  • QT-prolongation and torsade de pointes [see Warnings and Precautions (5.2)] Serotonin syndrome [see Warnings and Precautions (5.3)]

  • Increased risk of bleeding [see Warnings and Precautions (5.4)]

  • Activation of mania or hypomania [see Warnings and Precautions (5.5)]

  • Discontinuation syndrome [see Warnings and Precautions (5.6)]

  • Seizures [see Warnings and Precautions (5.7)]

  • Angle-closure glaucoma [see Warnings and Precautions (5.8)]

  • Hyponatremia [see Warnings and Precautions (5.9)]

  • Sexual Dysfunction [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

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6.2 Postmarketing Experience

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7 Drug Interactions

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8 Use in Specific Populations

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8.1 Pregnancy

8.2 Lactation

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8.4 Pediatric Use

The safety and effectiveness of CELEXA have not been established in pediatric patients. Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with CELEXA, and the data were not sufficient to support use in pediatric patients.

Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1)]. Decreased appetite and weight loss have been observed in association with the use of SSRIs in pediatric patients.

8.5 Geriatric Use

Of 4422 patients in clinical studies of CELEXA, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and over. In two pharmacokinetic studies, citalopram AUC was increased by 23% and 30%, respectively, in subjects greate than or equal to 60 years of age as compared to younger subjects, and its half-life was increased by 30% and 50%, respectively [see Clinical Pharmacology (12.3)]. Therefore, the maximum recommended dosage in patients 60 years of age and older is lower than younger patients [see Dosage and Administration (2.3),Warnings and Precautions (5.2)].

SSRIs, including CELEXA, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.9)].

Newly created:

8.6 Hepatic Impairment

Increased citalopram exposure occurs in patients with hepatic impairment. The maximum recommended dosage of CELEXA is lower in patients with hepatic impairment [see Dosage and Administration (2.3), Clinical Pharmacology (12.3)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

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PATIENT COUNSELING INFORMATION

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Other

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09/20/2021 (SUPPL-52)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions underlined)

Sexual Dysfunction: Advise patients that use of Celexa may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider (see WARNINGS).

WARNINGS

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Sexual Dysfunction

Use of SSRIs, including Celexa, may cause symptoms of sexual dysfunction (see ADVERSE REACTIONS). In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

It is important for prescribers to inquire about sexual function prior to initiation of Celexa and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported. When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Keep all follow?up visits with your healthcare provider and call between visits if you are worried about symptoms.

Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including Celexa, may cause sexual problems.

    • Symptoms in males may include:

      • Delayed ejaculation or inability to have an ejaculation

      • Decreased sex drive

      • Problems getting or keeping an erection

    • Symptoms in females may include:

      • Decreased sex drive

      • Delayed orgasm or inability to have an orgasm

        Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Celexa. There may be treatments your healthcare provider can suggest.

01/04/2017 (SUPPL-47)

Approved Drug Label (PDF)

5 Warnings and Precautions

Serotonin Syndrome

Additions and/or revisions below:

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Celexa, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, trytophan, buspirone, amphetamines, and St. John’s Wort) …

If concomitant use of Celexa with other serotonergic drugs including, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, trytophan and St. John’s Wort …