Caffedrine Side Effects

Generic Name: caffeine

Note: This page contains information about the side effects of caffeine. Some of the dosage forms included on this document may not apply to the brand name Caffedrine.

Not all side effects for Caffedrine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to caffeine: solution

Along with its needed effects, caffeine (the active ingredient contained in Caffedrine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking caffeine:

More common
  • Diarrhea
  • dizziness
  • fast heartbeat
  • hyperglycemia, including blurred vision, drowsiness, dry mouth, flushed dry skin, fruit-like breath odor, increased urination, ketones in urine, loss of appetite, nausea, stomachache, tiredness, troubled breathing, unusual thirst, or vomiting (in newborn babies)
  • hypoglycemia, including anxious feeling, blurred vision, cold sweats, confusion, cool pale skin, drowsiness, excessive hunger, fast heartbeat, nausea, nervousness, restless sleep, shakiness, or unusual tiredness or weakness (in newborn babies)
  • irritability, nervousness, or severe jitters (in newborn babies)
  • nausea (severe)
  • tremors
  • trouble in sleeping
  • vomiting
  • Abdominal or stomach bloating
  • dehydration
  • diarrhea (bloody)
  • unusual tiredness or weakness
Symptoms of overdose
  • Abdominal or stomach pain
  • agitation, anxiety, excitement, or restlessness
  • confusion or delirium
  • convulsions (seizures)—in acute overdose
  • dehydration
  • faster breathing rate
  • fast or irregular heartbeat
  • fever
  • frequent urination
  • headache
  • increased sensitivity to touch or pain
  • irritability
  • muscle trembling or twitching
  • nausea and vomiting, sometimes with blood
  • overextending the body with head and heels bent backward and body bowed forward
  • painful, swollen abdomen or vomiting (in newborn babies)
  • ringing or other sounds in ears
  • seeing flashes of "zig-zag" lights
  • whole-body tremors (in newborn babies)

Some side effects of caffeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Nausea (mild)
  • nervousness or jitters (mild)

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time, check with your doctor if you notice any of the following side effects:

More common
  • Anxiety
  • dizziness
  • headache
  • irritability
  • muscle tension
  • nausea
  • nervousness
  • stuffy nose
  • unusual tiredness

For Healthcare Professionals

Applies to caffeine: compounding powder, intravenous solution, oral gum, oral liquid, oral tablet, oral tablet dispersible, oral tablet extended release


In general, consumption of higher doses of caffeine (the active ingredient contained in Caffedrine) (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 side effects associated with caffeine (the active ingredient contained in Caffedrine) 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.


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 (the active ingredient contained in Caffedrine) 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 side effects have included confusion and psychotic symptoms.


Cardiovascular side effects associated with caffeine (the active ingredient contained in Caffedrine) products have rarely included tachycardia, increased left ventricular output, and increased stroke volume.

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.


Endocrine side effects associated with caffeine (the active ingredient contained in Caffedrine) products have rarely included alterations in serum glucose such as hypoglycemia and hyperglycemia.

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.

Nervous system

Nervous system side effects associated with caffeine (the active ingredient contained in Caffedrine) consumption have included central nervous system stimulation such as irritability, restlessness, and jitteriness.


Renal side effects associated with caffeine (the active ingredient contained in Caffedrine) consumption have included increased urine flow rate, creatinine clearance, and sodium and calcium excretion.


Genitourinary side effects associated with caffeine (the active ingredient contained in Caffedrine) products include urinary incontinence (UI) in men and women.

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