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Cafcit 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 Cafcit.

In Summary

More frequent side effects include: necrotizing enterocolitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to caffeine: oral capsule, oral capsule extended release, oral packet, oral powder for suspension, oral solution, oral tablet, oral tablet chewable, oral tablet enteric coated, oral tablet extended release

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by caffeine (the active ingredient contained in Cafcit). In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking caffeine:

More common:
  • Feeding intolerance
Less common:
  • Agitation
  • black, tarry stools
  • blood in the stools or urine
  • bruising
  • burning feeling or tenderness in the stomach
  • chills
  • coma
  • confusion
  • coughing or vomiting blood
  • decreased urine output
  • depression
  • dizziness
  • fainting
  • fast heartbeat
  • fever
  • headache
  • hostility
  • indigestion
  • irritability
  • lethargy
  • lightheadedness
  • muscle twitching
  • nausea
  • persistent bleeding
  • rapid, shallow breathing
  • rapid weight gain
  • rash
  • seizures
  • severe stomach pain
  • stomach upset
  • stupor
  • swelling of the face, ankles, or hands
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood or material that looks like coffee grounds

If any of the following symptoms of overdose occur while taking caffeine, get emergency help immediately:

Symptoms of overdose:
  • Irritability
  • nervousness
  • rapid heartbeat
  • trouble sleeping

Severity: Minor

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

More common:
  • Rash
Less common:
  • Dry skin

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 Cafcit) (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.[Ref]


Gastrointestinal side effects associated with caffeine (the active ingredient contained in Cafcit) citrate have included necrotizing enterocolitis in infants. Increased gastric aspirate and gastrointestinal intolerance have been reported rarely with caffeine products.[Ref]

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.[Ref]


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 Cafcit) 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.[Ref]

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.[Ref]


Psychiatric side effects have included confusion and psychotic symptoms.[Ref]


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

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.[Ref]


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

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.[Ref]

Nervous system

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


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


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


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2. Clementz GL, Dailey JW "Psychotropic effects of caffeine." Am Fam Physician 37 (1988): 167-72

3. Sawynok J "Pharmacological rationale for the clinical use of caffeine." Drugs 49 (1995): 37-50

4. Choi HK, Curhan G "Coffee, tea, and caffeine consumption and serum uric acid level: The third national health and nutrition examination survey." Arthritis Rheum 57 (2007): 816-821

5. "Product Information. Cafcit (caffeine)" Roxane Laboratories Inc, Columbus, OH.

6. Boyle CA, Berkowitz GS, LiVolsi VA, Ort S, Merino MJ, White C, Kelsey JL "Caffeine consumption and fibrocystic breast disease: a case-control epidemiologic study." J Natl Cancer Inst 72 (1984): 1015-9

7. Pfeiffer M, Stanojevic S, Feuchtinger T, et al. "Rituximab mediates in vitro antileukemic activity in pediatric patients after allogeneic transplantation." Bone Marrow Transplant (2005):

8. Sondermeijer H, van Marle A, Kamen P, Krum H "Acute effects of caffeine on heart rate variability." Am J Cardiol 90 (2002): 906

9. Hartley TR, Lovallo WR, Whitsett TL "Cardiovascular effects of caffeine in men and women." Am J Cardiol 93 (2004): 1022-6

10. Vlachopoulos C, Hirata K, Stefanadis C, Toutouzas P, O'Rourke MF "Caffeine increases aortic stiffness in hypertensive patients." Am J Hypertens 16 (2003): 63-6

11. Thong FS, Derave W, Kiens B, et al. "Caffeine-induced impairment of insulin action but not insulin signaling in human skeletal muscle is reduced by exercise." Diabetes 51 (2002): 583-90

12. Watson J, Deary I, Kerr D "Central and peripheral effects of sustained caffeine use: tolerance is incomplete." Br J Clin Pharmacol 54 (2002): 400-6

13. Biaggioni I, Davis SN "Caffeine: a cause of insulin resistance?" Diabetes Care 25 (2002): 399-400

14. "Summaries for patients. Coffee drinkers at lower risk for type 2 diabetes." Ann Intern Med 140 (2004): I17

15. Keijzers GB, De Galan BE, Tack CJ, Smits P "Caffeine can decrease insulin sensitivity in humans." Diabetes Care 25 (2002): 364-9

16. Davis NJ, Vaughan CP, Johnson TM 2nd, et al. "Caffeine Intake and its association with urinary incontinence in US men: Results from National Health and Nutritional Examination Surveys (NHANES) 2005-06 and 2007-08." J Urol 189 (2013): 2170-4

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.