NoDoz Side Effects

Please note - some side effects for NoDoz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of NoDoz - for the Consumer

NoDoz

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 NoDoz:

Dizziness; irritability; nausea; nervousness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; shakiness; trouble sleeping; vomiting.

Side Effects by Body System

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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