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Cafcit

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Cafcit

Cafcit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cafcit (caffeine citrate) is used to treat breathing problems in premature infants. It is a central nervous system stimulant. This medication is available in generic form. Common side effects include nausea, vomiting, stomach upset, headache, trouble sleeping, restlessness, poor feeding, rash or dry skin.

Cafcit is administered intravenously. Dose is based on the child's weight and baseline blood levels of caffeine. Cafcit may interact with cimetidine, ketoconazole, phenobarbital, phenytoin, or theophylline. Tell your doctor all medications you use. Cafcit should be used only when prescribed during pregnancy. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Cafcit (caffeine citrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cafcit in Detail - Patient Information: Side Effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using caffeine citrate and call your doctor at once if your child has any of these serious side effects:

  • stomach pain, tenderness, bloating,
  • constipation or diarrhea;
  • green-colored vomit;
  • blood in the stools;
  • unusual weakness;
  • seizure (convulsions);
  • twitching or uncontrolled muscle movements; or
  • fever, fast or slow heart rate.

Less serious side effects may include sleep problems, loss of appetite, fussiness, or excessive crying.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cafcit (Caffeine Citrate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cafcit Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach upset, headache, trouble sleeping, restlessness, poor feeding, rash or dry skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: trouble breathing, vision changes, change in the amount of urine.

In rare (sometimes, fatal) cases, this medication has been associated with a serious stomach condition (necrotizing enterocolitis). Tell your doctor immediately if your infant experiences the following: lack of energy (lethargy), severe vomiting, stomach/abdominal bloating (distension), bloody stool.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cafcit (Caffeine Citrate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cafcit FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the CAFCIT (caffeine citrate) (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 CAFCIT (caffeine citrate) treated patients than placebo.

ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN CAFCIT (caffeine citrate) TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY

Adverse Event (AE) CAFCIT (caffeine citrate)
N=46
n (%)
Placebo
N=39
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 CAFCIT (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, gastrointestinal intolerance), alterations in serum glucose (hypoglycemia and hyperglycemia) 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.

Read the entire FDA prescribing information for Cafcit (Caffeine Citrate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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