Home FDA labels f32e4ba0-3e6d-41b3-95f3-67b040cd4529 Caffeine Citrate openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Caffeine Citrate
Generic name CAFFEINE CITRATE
Manufacturer Sun Pharmaceutical Industries, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID d06d3810-9923-4199-be5e-ee5ee086b0a4
SPL ID f32e4ba0-3e6d-41b3-95f3-67b040cd4529
Version 4
Effective date 2019-03-01
Source export date 2026-09-28
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:14:36 Harmonized routes table Harmonized routes INTRAVENOUS
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warnings WARNINGS During the double-blind, placebo-controlled clinical trial, 6 cases of necro‑tizing enterocolitis developed among the 85 infants studied (caffeine=46, placebo=39), with 3 cases resulting in death. Five of the six patients with necrotizing enterocolitis were randomized to or had been exposed to caffeine citrate. Reports in the published literature have raised a question regarding the possi‑ble association between the use of methylxanthines and development of necro‑tizing enterocolitis, although a causal relationship between methylxanthine use and necrotizing enterocolitis has not been established. Therefore, as with all preterm infants, patients being treated with caffeine citrate should be carefully moni‑tored for the development of necrotizing enterocolitis.
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adverse reactions ADVERSE REACTIONS Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the caffeine citrate and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in caffeine citrate treated patients than placebo. ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN CAFFEINE CITRATE TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY Adverse Event (AE) Caffeine Citrate N=46 Placebo N=39 n (%) n (%) BODY AS A WHOLE Accidental Injury 1 (2.2) 0 (0.0) Feeding Intolerance 4 (8.7) 2 (5.1) Sepsis 2 (4.3) 0 (0.0) CARDIOVASCULAR SYSTEM Hemorrhage 1 (2.2) 0 (0.0) DIGESTIVE SYSTEM Necrotizing Enterocolitis 2 (4.3) 1 (2.6) Gastritis 1 (2.2) 0 (0.0) Gastrointestinal Hemorrhage 1 (2.2) 0 (0.0) HEMIC AND LYMPHATIC SYSTEM Disseminated Intravascular 1 (2.2) 0 (0.0) Coagulation METABOLIC AND NUTRITIVE DISORDERS Acidosis 1 (2.2) 0 (0.0) Healing Abnormal 1 (2.2) 0 (0.0) NERVOUS SYSTEM Cerebral Hemorrhage 1 (2.2) 0 (0.0) RESPIRATORY SYSTEM Dyspnea 1 (2.2) 0 (0.0) Lung Edema 1 (2.2) 0 (0.0) SKIN AND APPENDAGES Dry Skin 1 (2.2) 0 (0.0) Rash 4 (8.7) 3 (7.7) Skin Breakdown 1 (2.2) 0 (0.0) SPECIAL SENSES Retinopathy of Prematurity 1 (2.2) 0 (0.0) UROGENITAL SYSTEM Kidney Failure 1 (2.2) 0 (0.0) In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving caffeine citrate during the open-label phase of the study. Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to caffeine. Two were randomized to caffeine, and one placebo patient was “rescued” with open-label caffeine for uncontrolled apnea. Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointesti‑nal intolerance), alterations in serum glucose (hypoglycemia and hyper‑glycemia) and renal effects (increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown caffeine to adversely affect neurological development or growth parameters.
adverse reactions table <table ID="_RefID0EBEAE" cellpadding="0pt" cellspacing="0pt" width="100%"> <caption>ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN CAFFEINE CITRATE TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY </caption> <col width="45%"/> <col width="39%"/> <col width="15%"/> <tbody> <tr> <td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Adverse Event (AE) </paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule " valign="bottom"> <paragraph>Caffeine Citrate N=46 </paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule " valign="bottom"> <paragraph>Placebo N=39 </paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>n (%) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>n (%) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>BODY AS A WHOLE </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Accidental Injury </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Feeding Intolerance </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 (8.7) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 (5.1) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Sepsis </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 (4.3) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>CARDIOVASCULAR SYSTEM </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Hemorrhage </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>DIGESTIVE SYSTEM </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Necrotizing Enterocolitis </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>2 (4.3) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>1 (2.6) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Gastritis </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Gastrointestinal Hemorrhage </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>HEMIC AND LYMPHATIC SYSTEM </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Disseminated Intravascular </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Coagulation </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>METABOLIC AND NUTRITIVE DISORDERS </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Acidosis </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Healing Abnormal </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>NERVOUS SYSTEM </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Cerebral Hemorrhage </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>RESPIRATORY SYSTEM </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Dyspnea </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Lung Edema </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>SKIN AND APPENDAGES </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>Dry Skin </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Rash </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 (8.7) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 (7.7) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Skin Breakdown </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>SPECIAL SENSES </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Retinopathy of Prematurity </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph>UROGENITAL SYSTEM </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="middle"> <paragraph> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Kidney Failure </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2.2) </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>0 (0.0) </paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.