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What the label lists and what reports show

Citalopram side effects

Citalopram's FDA label: “Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ).” FAERS holds 136,040 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (9,113 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the citalopram FDA label on DailyMed (effective October 9, 2023, Allergan, Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of CELEXA?

CELEXA may cause serious side effects, including: See, “What is the most important information I should know about CELEXA?” Heart rhythm problems. CELEXA may cause a serious change in your heartbeat (a fast or irregular heartbeat) that may cause death. Tell your healthcare provider right away if you feel faint or pass out, or if you have a change in your heart beat. Serotonin syndrome. Taking CELEXA can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when CELEXA is taken with certain other medicines. […]

Source: FDA drug label, NDA020822 (Abbvie), as published by Allergan, Inc., effective October 9, 2023 (SPL set 4259d9b1-de34-43a4-85a8-41dd214e9177), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ).

Table 3: Adverse Reactions (≥2% and Greater than Placebo) Among CELEXA-Treated Patients*

Body System/Adverse ReactionCELEXA (N=1,063) %Placebo (N=446) %
Nausea2114
Diarrhea85
Dyspepsia54
Vomiting43
Abdominal Pain32
Dry Mouth2014
Sweating Increased119
Somnolence1810
Insomnia1514
Anxiety43
Anorexia42
Agitation31
Dysmenorrhea 132
Libido Decreased2<1
Yawning2<1
Tremor86
Ejaculation Disorder 2,361
Impotence 33<1
Upper Respiratory Tract Infection54
Rhinitis53
Sinusitis3<1
Fatigue53
Fever2<1
Arthralgia21
Myalgia21

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

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 )] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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 conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Source: FDA drug label, NDA020822 (Abbvie), as published by Allergan, Inc., effective October 9, 2023 (SPL set 4259d9b1-de34-43a4-85a8-41dd214e9177), via openFDA; the full label on DailyMed

What do FAERS reports show?

136,040 reports list citalopram among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18,996 are coded as a death and 45,958 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Fatigue (named in the label)9,113
  • Nausea (named in the label)8,344
  • Drug Ineffective (a use or a product term, not a reaction)7,438
  • Headache (named in the label)6,792
  • Diarrhoea (named in the label)6,347
  • Pain6,021
  • Dizziness (named in the label)5,812
  • Fall5,712
  • Anxiety (named in the label)5,542
  • Dyspnoea (named in the label)5,421
  • Off Label Use (a use or a product term, not a reaction)5,335
  • Depression (a use or a product term, not a reaction)5,274
  • Toxicity To Various Agents5,190
  • Vomiting (named in the label)5,062
  • Drug Interaction (a use or a product term, not a reaction)4,447
  • Completed Suicide (an outcome recorded in the report)4,402
  • Malaise4,316
  • Asthenia (named in the label)4,192
  • Arthralgia (named in the label)3,972
  • Death (an outcome recorded in the report)3,780
  • Insomnia (named in the label)3,651
  • Confusional State3,276
  • Rash (named in the label)3,269
  • Somnolence (named in the label)3,242
  • Pyrexia3,240

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Citalopram: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions