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Caffeine citrate Side Effects

Brand Names: Cafcit

Please note - some side effects for Caffeine citrate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Caffeine citrate Side Effects - for the Professional

Caffeine Citrate

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
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 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 (i.e., hypoglycemia and hyperglycemia) and renal effects (i.e., 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.

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Side 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.

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