Drug · FAERS side-effect profile with label screen
Cyproheptadine side effects: what 4,406 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Cyproheptadine Hydrochloride (Cyproheptadine Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,406 reports · 68% serious · 305 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma C.
FDA label, Indications and Usage
What it is
DESCRIPTION Cyproheptadine hydrochloride, USP is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride, USP is a white to slightly yellow, odorless or practically odorless.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 3Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 34
What the badges mean
- 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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 255 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Serotonin syndrome | 189 | 47.5 41.2–54.6ROR 49.5 · χ² 8,470 / p <1e-300 | 46.8 EB05 41.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 40.2 · 96% clinician | no trial data cached |
| Sleep apnoea syndrome | 48 | 12.0 9.0–15.9ROR 12.1 · χ² 471 / p 1e-104 | 11.6 EB05 9.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 93% (drug 55%) | no trial data cached |
| Malnutrition | 23 | 9.9 6.6–14.8ROR 9.9 · χ² 174 / p 5e-40 | 8.9 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| End stage renal disease | 37 | 9.6 6.9–13.2ROR 9.6 · χ² 275 / p 4e-62 | 9.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Infusion site pain | 24 | 9.0 6.0–13.3ROR 9.0 · χ² 161 / p 3e-37 | 8.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pharyngitis streptococcal | 19 | 8.4 5.3–13.1ROR 8.4 · χ² 116 / p 3e-27 | 7.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Fibromyalgia | 41 | 8.0 5.9–10.9ROR 8.1 · χ² 246 / p 1e-55 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 100% (drug 55%) | no trial data cached |
| Mental status changes | 46 | 7.9 5.9–10.5ROR 8.0 · χ² 269 / p 7e-61 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 93% clinician | no trial data cached |
| Pneumonia aspiration | 40 | 7.6 5.6–10.4ROR 7.7 · χ² 224 / p 5e-51 | 7.1 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 19% (drug 55%) | no trial data cached |
| Muscle rigidity | 18 | 7.2 4.5–11.4ROR 7.2 · χ² 89 / p 2e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Economic problem | 23 | 7.1 4.7–10.7ROR 7.1 · χ² 115 / p 5e-27 | 6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Anhedonia | 39 | 7.0 5.1–9.6ROR 7.1 · χ² 195 / p 1e-44 | 6.5 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Sedation | 38 | 6.9 5.1–9.5ROR 7.0 · χ² 187 / p 6e-43 | 6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Neuroleptic malignant syndrome | 17 | 6.8 4.2–10.9ROR 6.8 · χ² 78 / p 4e-19 | 5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Personality change | 13 | 6.6 3.8–11.4ROR 6.6 · χ² 56 / p 3e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Agitation | 100 | 6.5 5.3–7.8ROR 6.6 · χ² 457 / p 9e-102 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 76% (drug 55%) | no trial data cached |
| Mood swings | 43 | 6.4 4.8–8.6ROR 6.5 · χ² 191 / p 8e-44 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 91% clinician | no trial data cached |
| Mydriasis | 17 | 6.3 3.9–10.2ROR 6.3 · χ² 71 / p 2e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Ear infection | 34 | 6.1 4.4–8.5ROR 6.1 · χ² 140 / p 1e-32 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Sinus tachycardia | 18 | 6.0 3.8–9.6ROR 6.1 · χ² 71 / p 2e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Restlessness | 46 | 6.0 4.5–8.0ROR 6.0 · χ² 186 / p 1e-42 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Impaired gastric emptying | 16 | 6.0 3.7–9.7ROR 6.0 · χ² 61 / p 2e-15 | 5.2 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Viral infection | 40 | 5.7 4.2–7.8ROR 5.8 · χ² 151 / p 4e-35 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pneumothorax | 19 | 5.7 3.6–8.9ROR 5.7 · χ² 69 / p 5e-17 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cystitis | 38 | 5.7 4.1–7.8ROR 5.7 · χ² 141 / p 7e-33 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 97% (drug 55%) | no trial data cached |
| Sleep disorder due to a general medical condition | 19 | 5.6 3.6–8.8ROR 5.6 · χ² 67 / p 1e-16 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Electrocardiogram qt prolonged | 42 | 5.6 4.1–7.5ROR 5.6 · χ² 152 / p 3e-35 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Chronic kidney disease | 88 | 5.5 4.4–6.7ROR 5.6 · χ² 317 / p 3e-71 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Irritability | 69 | 5.5 4.3–6.9ROR 5.5 · χ² 247 / p 6e-56 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Cardiogenic shock | 16 | 5.3 3.3–8.7ROR 5.4 · χ² 52 / p 3e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Bone density decreased | 35 | 5.3 3.8–7.3ROR 5.3 · χ² 117 / p 2e-27 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Generalised tonic-clonic seizure | 18 | 5.2 3.3–8.3ROR 5.3 · χ² 58 / p 2e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Myoclonus | 13 | 5.2 3.0–8.9ROR 5.2 · χ² 40 / p 1e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Migraine | 103 | 5.2 4.3–6.3ROR 5.3 · χ² 343 / p 6e-77 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 84% (drug 55%) | no trial data cached |
| Intentional overdose | 69 | 5.2 4.1–6.5ROR 5.2 · χ² 227 / p 1e-51 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 100% clinician | no trial data cached |
| Status epilepticus | 12 | 5.0 2.9–8.9ROR 5.1 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Feeding disorder | 21 | 5.0 3.3–7.7ROR 5.0 · χ² 64 / p 8e-16 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Impaired quality of life | 15 | 5.0 3.0–8.2ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Mood altered | 28 | 4.9 3.4–7.1ROR 4.9 · χ² 83 / p 4e-20 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 84% (drug 55%) | no trial data cached |
| Psychomotor hyperactivity | 17 | 4.9 3.0–7.8ROR 4.9 · χ² 48 / p 2e-12 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Pneumonia (lung infection) | 202 | 3.0 2.6–3.4ROR 3.1 · χ² 267 / p 3e-60 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Anxiety | 189 | 3.2 2.7–3.6ROR 3.2 · χ² 279 / p 6e-63 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Serotonin syndrome | 189 | 47.5 41.2–54.6ROR 49.5 · χ² 8,470 / p <1e-300 | 46.8 EB05 41.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 40.2 · 96% clinician | no trial data cached |
| Weight decreased (weight loss) | 175 | 3.0 2.6–3.5ROR 3.1 · χ² 232 / p 1e-52 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Decreased appetite (loss of appetite) | 175 | 3.6 3.1–4.2ROR 3.7 · χ² 329 / p 9e-74 | 3.6 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Abdominal pain | 149 | 3.0 2.6–3.6ROR 3.1 · χ² 205 / p 7e-47 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Cough | 144 | 2.4 2.1–2.9ROR 2.5 · χ² 124 / p 5e-29 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Product dose omission issue | 133 | 2.2 1.9–2.6ROR 2.3 · χ² 89 / p 2e-21 | 2.2 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Product use in unapproved indication | 132 | 2.6 2.2–3.0ROR 2.6 · χ² 127 / p 1e-29 | 2.6 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Abdominal pain upper | 115 | 2.7 2.2–3.2ROR 2.7 · χ² 119 / p 6e-28 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Depression | 111 | 2.3 1.9–2.8ROR 2.3 · χ² 82 / p 7e-20 | 2.3 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 · ♀ 79% (drug 55%) | no trial data cached |
| Drug interaction | 111 | 3.3 2.8–4.0ROR 3.4 · χ² 180 / p 3e-41 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Hospitalisation | 111 | 3.5 2.9–4.2ROR 3.5 · χ² 194 / p 3e-44 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Migraine | 103 | 5.2 4.3–6.3ROR 5.3 · χ² 343 / p 6e-77 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 84% (drug 55%) | no trial data cached |
| Agitation | 100 | 6.5 5.3–7.8ROR 6.6 · χ² 457 / p 9e-102 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 76% (drug 55%) | no trial data cached |
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.
- Serotonin syndrome — n=189, PRR 47.5
- Sleep apnoea syndrome — n=48, PRR 12.0
- Malnutrition — n=23, PRR 9.9
- End stage renal disease — n=37, PRR 9.6
- Infusion site pain — n=24, PRR 9.0
- Fibromyalgia — n=41, PRR 8.0
- Mental status changes — n=46, PRR 7.9
- Pneumonia aspiration — n=40, PRR 7.6
- Anhedonia — n=39, PRR 7.0
- Agitation — n=100, PRR 6.5
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 Cyproheptadine?
In FDA FAERS, the most frequently co-reported reaction terms for Cyproheptadine are pneumonia, anxiety, serotonin syndrome, weight decreased, decreased appetite, abdominal pain. 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 Cyproheptadine have an FDA boxed warning?
No. The FDA label retrieved for Cyproheptadine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cyproheptadine 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 0e43e99b-2e0b-4f55-b93a-a6908634880d, effective 20231102; matched on
openfda.generic_name.exact:"CYPROHEPTADINE HYDROCHLORIDE") - 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, 295 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
Page generated 2026-10-08. 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.