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What the label lists and what reports show

Cyproheptadine side effects

Cyproheptadine's FDA label lists its adverse reactions in its own words. FAERS holds 4,410 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 diarrhoea (247 reports).

  • Generic listed

Check it at the source: the cyproheptadine FDA label on DailyMed (effective March 6, 2026, Strides Pharma Science Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Special Senses Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Cardiovascular Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. Hematologic Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. …

Source: FDA drug label, Strides Pharma Science Limited, effective March 6, 2026 (SPL set b28c2ca0-140d-44d8-a59e-75fbfe8eabdd), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,410 reports list cyproheptadine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 305 are coded as a death and 1,836 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, 7 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

  • Off Label Use (a use or a product term, not a reaction)346
  • Drug Ineffective (a use or a product term, not a reaction)299
  • Diarrhoea (named in the label)247
  • Vomiting (named in the label)237
  • Nausea (named in the label)233
  • Fatigue (named in the label)230
  • Pneumonia202
  • Headache (named in the label)197
  • Anxiety189
  • Serotonin Syndrome189
  • Decreased Appetite175
  • Weight Decreased175
  • Pyrexia165
  • Pain151
  • Abdominal Pain149
  • Cough144
  • Dizziness (named in the label)140
  • Rash (named in the label)135
  • Product Dose Omission Issue (a use or a product term, not a reaction)133
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)132
  • Dyspnoea127
  • Condition Aggravated (a use or a product term, not a reaction)124
  • Death (an outcome recorded in the report)119
  • Infective Pulmonary Exacerbation Of Cystic Fibrosis117
  • Abdominal Pain Upper115

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

What next?

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