Cafcit Side Effects
Generic Name: caffeine,caffeine; caffeine and sodium benzoate injection; caffeine citrate
Please note - some side effects for Cafcit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Cafcit - for the Consumer
Cafcit Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cafcit Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Cafcit Solution:Irritability; restlessness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in the amount of urine; seizures; stomach pain or swelling; unusual tiredness (lethargy); vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCafcit Side Effects - for the Professional
Cafcit
Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Cafcit (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-treated patients than placebo.
| Adverse Event (AE) |
Cafcit 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 Coagulation | 1 (2.2) | 0 (0.0) |
|
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 (ie, irritability, restlessness, jitteriness), cardiovascular effects (ie, tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (ie, increased gastric aspirate, gastrointestinal intolerance), alterations in serum glucose (ie, hypoglycemia and hyperglycemia), and renal effects (ie, 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.
Overdosage
Following overdose, serum caffeine levels have ranged from approximately 24 mg/L (a postmarketing spontaneous case report in which an infant exhibited irritability, poor feeding, and insomnia) to 350 mg/L. Serious toxicity has been associated with serum levels greater than 50 mg/L. Signs and symptoms reported in the literature after caffeine overdose in preterm infants include fever, tachypnea, jitteriness, insomnia, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycemia, elevated blood urea nitrogen, and elevated total leukocyte concentration. Seizures have also been reported in cases of overdose. One case of caffeine overdose complicated by development of intraventricular hemorrhage and long-term neurological sequelae has been reported. Another case of caffeine citrate overdose (from New Zealand; not Cafcit) of an estimated 600 mg caffeine citrate (approximately 322 mg/kg) administered over 40 minutes was complicated by tachycardia, ST depression, respiratory distress, heart failure, gastric distention, acidosis, and a severe extravasation burn with tissue necrosis at the peripheral intravenous injection site. No deaths associated with caffeine overdose have been reported in preterm infants.
Treatment of caffeine overdose is primarily symptomatic and supportive. Caffeine levels have been shown to decrease after exchange transfusions. Convulsions may be treated with intravenous administration of diazepam or a barbiturate such as pentobarbital sodium.
TopSide Effects by Body System - for Healthcare Professionals
General
In general, consumption of higher doses of caffeine (less than 600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate premenstrual syndrome (PMS).
Two studies have shown that caffeine consumption is associated with a lower serum uric acid level and a lower risk of incident gout.
Gastrointestinal
Gastrointestinal side effects associated with caffeine citrate have included necrotizing enterocolitis in infants. Increased gastric aspirate and gastrointestinal intolerance have been reported rarely with caffeine products.
In clinical trials of caffeine citrate, six cases of necrotizing enterocolitis (3 fatal) were reported among 85 infants exposed to caffeine citrate injection, however, causality has not been established.
Other
In one study of 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.
Other side effects associated with caffeine consumption have included fibrocystic breast disease in women.
One study has reported that while favorable subjective and performance-enhancing stimulant effects occur at low to intermediate caffeine doses, the unfavorable subjective and somatic effects, as well as performance disruption from high doses of caffeine may intrinsically limit the doses of caffeine used in the general population.
Psychiatric
Psychiatric side effects have included confusion and psychotic symptoms.
Cardiovascular
One study (n=77) reported increased blood pressure following caffeine intake (3.3 mg/kg) of approximately 4.5 mmHg in premenopausal women and 4.1 mmHg in men. Although men and women showed similar responses in blood pressure following consumption of a dietary dose of caffeine the hemodynamic mechanisms facilitating this change are different. Premenopausal women showed an increase in cardiac output whereas men showed increased vascular resistance.
One small study (n=12) reports caffeine to exert an acute unfavorable effect on aortic stiffness in treated hypertensive patients. This effect peaked approximately 60 minutes following administration of caffeine 250 mg orally, lasted a minimum duration of approximately 3 hours, and then decreased gradually.
Cardiovascular side effects associated with caffeine products have rarely included tachycardia, increased left ventricular output, and increased stroke volume.
Endocrine
Several studies report a decrease in insulin sensitivity in individuals following caffeine consumption. The mechanism leading to this effect is unknown but may be related to elevated serum epinephrine levels.
A few studies report a possible decreased risk of type 2 diabetes mellitus in individuals who consume coffee.
Endocrine side effects associated with caffeine products have rarely included alterations in serum glucose such as hypoglycemia and hyperglycemia.
Nervous system
Nervous system side effects associated with caffeine consumption have included central nervous system stimulation such as irritability, restlessness, and jitteriness.
Renal
Renal side effects associated with caffeine consumption have included increased urine flow rate, creatinine clearance, and sodium and calcium excretion.
TopMore Cafcit resources
- Cafcit Concise Consumer Information (Cerner Multum)
- Cafcit Solution MedFacts Consumer Leaflet (Wolters Kluwer)
- Cafcit Advanced Consumer (Micromedex) - Includes Dosage Information
- Cafcit Prescribing Information (FDA)
- Caffeine Professional Patient Advice (Wolters Kluwer)
- Caffeine MedFacts Consumer Leaflet (Wolters Kluwer)
- Caffeine; Caffeine and Sodium Benzoate Injection; Caffeine Citrate Monograph (AHFS DI)
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