Citalopram Hydrobromide side effects: what 106,538 FDA adverse event reports show
Drug class
Selective serotonin reuptake inhibitor (ssri)
Who reports
106,538 reports · 82% serious · 17,005 with death outcome · 66% female
Used for
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .
What it is
Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula:
Boxed 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 )] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,144 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Temperature regulation disorder | 550 | 66.1 60.0–72.8ROR 66.5 · calibrated p 2e-6 ✓ | 49.4 EB05 46.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=547 · ♀ 91% (drug 66%) | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 171 | 64.1 54.0–76.3ROR 64.3 · calibrated p 3e-6 ✓ | 48.2 EB05 42.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=171 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Cardiospasm | 77 | 31.4 24.7–39.9ROR 31.4 · calibrated p 2e-4 ✓ | 27.0 EB05 22.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=77 · ♀ 100% (drug 66%) | not reported in cached trials |
| Agitation neonatal | 127 | 30.1 25.0–36.3ROR 30.2 · calibrated p 3e-4 ✓ | 26.1 EB05 22.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=125 · ♀ 0% (drug 66%) | not reported in cached trials |
| Disinhibition | 213 | 29.9 25.9–34.5ROR 29.9 · calibrated p 3e-4 ✓ | 25.9 EB05 23.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=213 · ♀ 0% (drug 66%) | not reported in cached trials |
| Respiratory disorder neonatal | 201 | 28.3 24.4–32.9ROR 28.4 · calibrated p 4e-4 ✓ | 24.8 EB05 22.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=201 · ♀ 32% (drug 66%) | not reported in cached trials |
| Steroid dependence | 105 | 27.6 22.5–33.9ROR 27.7 · calibrated p 5e-4 ✓ | 24.2 EB05 20.6 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=105 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Catarrh | 102 | 25.4 20.7–31.2ROR 25.4 · calibrated p 7e-4 ✓ | 22.5 EB05 19.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=102 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Palmoplantar keratoderma | 77 | 23.5 18.5–29.7ROR 23.5 · calibrated p 0.001 ✓ | 20.9 EB05 17.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=77 · ♀ 100% (drug 66%) | not reported in cached trials |
| Psychiatric decompensation | 189 | 21.0 18.1–24.4ROR 21.1 · calibrated p 0.002 ✓ | 19.0 EB05 16.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=189 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Anorgasmia | 226 | 17.8 15.5–20.3ROR 17.8 · calibrated p 0.003 ✓ | 16.3 EB05 14.6 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=216 | not reported in cached trials |
| Disturbance in sexual arousal | 76 | 17.6 14.0–22.3ROR 17.7 · calibrated p 0.004 ✓ | 16.2 EB05 13.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=75 · ♀ 0% (drug 66%) · 100% consumer | not reported in cached trials |
| Genital hypoaesthesia | 82 | 17.4 13.9–21.8ROR 17.4 · calibrated p 0.004 ✓ | 16.0 EB05 13.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=80 · ♀ 0% (drug 66%) · 100% consumer | not reported in cached trials |
| Accidental death | 145 | 16.6 14.0–19.7ROR 16.7 · calibrated p 0.005 ✓ | 15.4 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=145 · 100% clinician | not reported in cached trials |
| Food allergy | 585 | 16.4 15.1–17.9ROR 16.5 · calibrated p 0.005 ✓ | 15.2 EB05 14.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=580 · ♀ 100% (drug 66%) | not reported in cached trials |
| Serotonin syndrome | 1,406 | 15.5 14.7–16.4ROR 15.7 · calibrated p 0.006 ✓ | 14.5 EB05 13.8 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 13.6 · serious PRR 10.2 · 91% clinician | not reported in cached trials |
| Depressive symptom | 245 | 14.7 12.9–16.7ROR 14.7 · calibrated p 0.008 ✓ | 13.7 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=237 · ♀ 26% (drug 66%) | not reported in cached trials |
| Tearfulness | 291 | 14.1 12.6–15.9ROR 14.2 · calibrated p 0.009 ✓ | 13.2 EB05 12.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=271 · ♀ 40% (drug 66%) | not reported in cached trials |
| Depression suicidal | 225 | 13.6 11.9–15.6ROR 13.6 · calibrated p 0.011 ✓ | 12.7 EB05 11.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=224 · ♀ 30% (drug 66%) | not reported in cached trials |
| Bradycardia neonatal | 80 | 13.4 10.7–16.8ROR 13.4 · calibrated p 0.012 ✓ | 12.4 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=80 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Psychomotor skills impaired | 167 | 13.3 11.4–15.5ROR 13.3 · calibrated p 0.012 ✓ | 12.4 EB05 10.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=166 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Alcohol poisoning | 167 | 13.2 11.3–15.4ROR 13.2 · calibrated p 0.012 ✓ | 12.3 EB05 10.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=167 · ♀ 40% (drug 66%) | not reported in cached trials |
| Burns second degree | 109 | 13.0 10.7–15.8ROR 13.0 · calibrated p 0.013 ✓ | 12.1 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Small for dates baby | 285 | 11.9 10.5–13.4ROR 11.9 · calibrated p 0.018 ✓ | 11.2 EB05 10.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=285 | not reported in cached trials |
| Foetal death | 287 | 11.5 10.2–12.9ROR 11.5 · calibrated p 0.020 ✓ | 10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=287 · ♀ 100% (drug 66%) · 91% clinician | not reported in cached trials |
| Long qt syndrome | 130 | 11.2 9.4–13.3ROR 11.2 · calibrated p 0.023 ✓ | 10.5 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious n=130 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Blood pressure systolic abnormal | 133 | 11.1 9.3–13.2ROR 11.1 · calibrated p 0.024 ✓ | 10.4 EB05 8.9 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=127 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Multiple drug overdose | 259 | 10.6 9.4–12.0ROR 10.6 · calibrated p 0.026 ✓ | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=258 · 100% clinician | not reported in cached trials |
| Hyperreflexia | 180 | 10.6 9.1–12.3ROR 10.6 · calibrated p 0.027 ✓ | 10.0 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=179 · 100% clinician | not reported in cached trials |
| Multiple drug overdose intentional | 164 | 10.4 8.9–12.1ROR 10.4 · calibrated p 0.029 ✓ | 9.8 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=163 · 100% clinician | not reported in cached trials |
| Completed suicide (death by suicide) | 4,210 | 10.3 10.0–10.6ROR 10.7 · calibrated p 0.025 ✓ | 9.8 EB05 9.6 · IC025 +3.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 7.9 · serious PRR 6.9 · 96% clinician | not reported in cached trials |
| Torsade de pointes | 383 | 10.0 9.1–11.1ROR 10.1 · calibrated p 0.032 ✓ | 9.5 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.7 · 100% clinician | not reported in cached trials |
| Coeliac disease | 476 | 10.0 9.1–10.9ROR 10.0 · calibrated p 0.032 ✓ | 9.5 EB05 8.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 100% (drug 66%) | not reported in cached trials |
| Nephrogenic anaemia | 226 | 10.0 8.7–11.4ROR 10.0 · calibrated p 0.033 ✓ | 9.4 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=226 | not reported in cached trials |
| Bruxism | 260 | 9.9 8.8–11.2ROR 9.9 · calibrated p 0.034 ✓ | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=246 | not reported in cached trials |
| Blood pressure diastolic abnormal | 123 | 9.8 8.2–11.8ROR 9.9 · calibrated p 0.035 ✓ | 9.3 EB05 7.9 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=119 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Alcohol interaction | 93 | 9.8 8.0–12.1ROR 9.8 · calibrated p 0.036 ✓ | 9.2 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=90 | not reported in cached trials |
| Atrial tachycardia | 99 | 9.6 7.9–11.8ROR 9.7 · calibrated p 0.038 ✓ | 9.0 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=99 · ♀ 100% (drug 66%) | not reported in cached trials |
| Coma scale abnormal | 129 | 9.2 7.7–11.0ROR 9.3 · calibrated p 0.043 ✓ | 8.7 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=130 · 100% clinician | not reported in cached trials |
| Electrocardiogram qt prolonged | 1,616 | 9.2 8.8–9.7ROR 9.3 · calibrated p 0.041 ✓ | 8.8 EB05 8.5 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 7.9 · serious PRR 6.3 · 92% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Suicidality | 8,063 | 6.66.5–6.8 | signal |
| Hyponatraemia | 2,026 | 5.14.8–5.3 | signal |
| Extrapyramidal | 1,876 | 3.53.4–3.7 | signal |
| Arrhythmia / qt | 3,132 | 3.23.1–3.3 | signal |
| Depression | 4,422 | 3.13.0–3.2 | signal |
| Fall / fracture | 4,743 | 2.52.4–2.5 | signal |
| Gi bleeding | 2,001 | 2.22.1–2.3 | signal |
| Rhabdomyolysis / myopathy | 865 | 2.12.0–2.3 | raised |
| Seizure | 1,893 | 1.91.8–2.0 | raised |
| Kidney injury | 3,899 | 1.71.6–1.7 | raised |
| Liver injury | 2,454 | 1.61.5–1.7 | raised |
| Hypoglycaemia | 767 | 1.61.5–1.7 | raised |
| Anaemia | 2,264 | 1.51.4–1.6 | raised |
| Serious infection | 5,594 | 1.41.4–1.5 | raised |
| Thrombocytopenia | 1,554 | 1.41.3–1.5 | raised |
| Venous thromboembolism | 1,520 | 1.41.3–1.5 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Citalopram Hydrobromide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01473381 — Safety and Efficacy of Vilazodone in Major Depressive Disorder (N=1162, PHASE4; 41 AE terms posted; arms: Placebo; Vilazodone 20 mg/Day; Vilazodone 40 mg/Day; Citalopram 40 mg/Day)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 6,990 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.849 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.8 | NCT01473381: 20/282 (7.1%) on Citalopram Hydrobromide; 9/281 (3.2%) control |
| Nausea | 6,017 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.664 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | NCT01473381: 55/282 (19.5%) on Citalopram Hydrobromide; 23/281 (8.2%) control |
| Drug ineffective (drug did not work) | 5,544 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.194 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.1 | not reported in cached trials |
| Headache | 5,145 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.740 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.8 | NCT01473381: 42/282 (14.9%) on Citalopram Hydrobromide; 39/281 (13.9%) control |
| Toxicity to various agents | 5,100 | 6.1 6.0–6.3ROR 6.4 · calibrated p 0.127 | 6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.6 · serious PRR 4.3 · 94% clinician | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,832 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.645 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT01473381: 30/282 (10.6%) on Citalopram Hydrobromide; 26/281 (9.3%) control |
| Fall | 4,460 | 2.7 2.6–2.7ROR 2.7 · calibrated p 0.719 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 2.0 | not reported in cached trials |
| Pain | 4,427 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.600 | 1.4 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.3 | NCT01473381: 1/281 (0.4%) control (serious AE) |
| Dizziness | 4,425 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.823 | 1.7 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.8 | NCT01473381: 1/288 (0.3%) on Citalopram Hydrobromide (serious AE) |
| Off label use (used outside approved label) | 4,363 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.299 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.1 | not reported in cached trials |
| Completed suicide (death by suicide) | 4,210 | 10.3 10.0–10.6ROR 10.7 · calibrated p 0.025 ✓ | 9.8 EB05 9.6 · IC025 +3.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 7.9 · serious PRR 6.9 · 96% clinician | not reported in cached trials |
| Dyspnoea (shortness of breath) | 4,145 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.618 | 1.4 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.2 | not reported in cached trials |
| Drug interaction | 4,102 | 5.2 5.0–5.4ROR 5.4 · calibrated p 0.198 | 5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.5 · serious PRR 3.9 | not reported in cached trials |
| Anxiety | 3,963 | 2.8 2.7–2.8ROR 2.8 · calibrated p 0.685 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.5 | not reported in cached trials |
| Vomiting | 3,786 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.716 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.4 | NCT01473381: 5/282 (1.8%) on Citalopram Hydrobromide; 7/281 (2.5%) control |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Temperature regulation disorder — n=550, PRR 66.1
- Cardiospasm — n=77, PRR 31.4
- Agitation neonatal — n=127, PRR 30.1
- Disinhibition — n=213, PRR 29.9
- Respiratory disorder neonatal — n=201, PRR 28.3
- Catarrh — n=102, PRR 25.4
- Palmoplantar keratoderma — n=77, PRR 23.5
- Psychiatric decompensation — n=189, PRR 21.0
- Disturbance in sexual arousal — n=76, PRR 17.6
- Genital hypoaesthesia — n=82, PRR 17.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Citalopram ↔ QT prolongation.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Citalopram Hydrobromide?
In FDA FAERS, the most frequently co-reported reaction terms for Citalopram Hydrobromide are fatigue, nausea, headache, toxicity to various agents, diarrhoea, fall. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Citalopram Hydrobromide have an FDA boxed warning?
Yes. The current FDA label carries a boxed 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 )] .
Do FAERS signals prove that Citalopram Hydrobromide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 05421bee-f746-418e-bb9c-ab44a89b567d, effective 20240918; matched on
openfda.generic_name.exact:"CITALOPRAM HYDROBROMIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 77995 description ()
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,184 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
CITALOPRAM HYDROBROMIDE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.