Caffeine: uses, dosing, side effects & brands

Caffeine is a central nervous system stimulant sold in the U.S. under 2 brand and generic names, for apnea and fatigue. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Central Nervous System Stimulant
Treats (across its forms): Apnea and Fatigue
Available as: Injectable · Solution
Sold as: 2 products — Cafcit and Caffeine Citrate
Prescription?: Prescription only
Generic available?: Yes
What the pharmacy pays: about $3 for a 30-count supply — not your price

How caffeine is dosed

From the FDA label for Caffeine Citrate (application ANDA077997). Other caffeine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Prior to initiation of caffeine citrate injection, baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who consumed caffeine prior to delivery, since caffeine readily crosses the placenta. The recommended loading dose and maintenance doses of caffeine citrate follow. *Using a syringe infusion pump **Beginning 24 hours after the loading dose Dose of Caffeine Citrate Volume Dose of Caffeine Citrate mg/kg Route Frequency Loading Dose 1 mL/kg 20 mg/kg Intravenous* (over 30 minutes) One time Maintenance Dose 0.25 mL/kg 5 mg/kg Intravenous* (over 10 minutes) or Orally Every 24 hours** NOTE THAT THE DOSE OF CAFFEINE BASE IS ONE-HALF THE DOSE WHEN EXPRESSED AS CAFFEINE CITRATE (e.g., 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base). Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L. Caffeine citrate injection should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded. Drug Compatibility To test for drug compatibility…

Caffeine side effects

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 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…

Who shouldn’t take caffeine

Caffeine citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Caffeine drug interactions

Cytochrome P450 1A2 (CYP1A2) is known to be the major enzyme involved in the metabolism of caffeine. Therefore, caffeine has the potential to interact with drugs that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2. Few data exist on drug interactions with caffeine in preterm neonates. Based on adult data, lower doses of caffeine may be needed following coadministration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin). Caffeine administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers. The clinical significance of this interaction in preterm neonates is not known. Interconversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.

Can you take caffeine with…?

Source-cited answers for the combinations people actually ask about — each with a verdict and what to watch for.

Can you drink coffee while taking Adderall? →Can you take Excedrin and naproxen (Aleve) together? →Check any combination →

Every caffeine product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Caffeine products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Cafcit	72/100	Prescription	Injectable	Generic	$3	View →
2	Caffeine Citrate	68/100	Prescription	Injectable	Generic	$3	View →

What caffeine pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Caffeine pill imprints
Imprint	Strength	Colour	Shape	Maker
HH6	65 mg / 250 mg	white	capsule	—
TCL370	250 mg / 250 mg / 65 mg	white	capsule	—
I1	250 mg / 65 mg / 250 mg	white	capsule	—
I1	250 mg / 65 mg / 250 mg	white	capsule	—
S777	500 mg / 65 mg	red	capsule	—
S79	60 mg / 15 mg / 500 mg	blue	capsule	—
S79	60 mg / 15 mg / 500 mg	blue	capsule	—
TCL370	250 mg / 250 mg / 65 mg	white	capsule	—
TCL373	500 mg / 65 mg	red	oval	—
S77	250 mg / 250 mg / 65 mg	green	round	—
S79	500 mg / 60 mg / 15 mg	blue	capsule	—
S77	250 mg / 250 mg / 65 mg	green	round	—

Combination products containing caffeine

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Caffeine recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Aero Healthcare · Oct 17, 2025

Can you crush or split caffeine?

At least one caffeineproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.

What each caffeine label says about crushing, splitting and chewing

Caffeine and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Caffeine appears in breastmilk rapidly after maternal ingestion. Insufficient high-quality data are available to make good evidence-based recommendations on safe maternal caffeine consumption. Fussiness, jitteriness and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes equivalent to about 10 or more cups of coffee daily. Studies in mothers taking 5 cups of coffee daily found no stimulation in breastfed infants 3 weeks of age and older. A maternal intake limit of 300 to 500 mg daily might be a safe level of intake for most mothers, although European authorities set a likely safe level at 200 mg. Maternal doses of caffeine greater than 130 mg daily may decrease weight gain in their exclusively breastfed infants, but this needs further confirmation. However, preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers' levels, so a lower intake level preferable in the mothers of these infants. Coffee is thought to decrease milk supply in some cultures, but there is no scientific information on coffee and milk supply. Other sources of caffeine, such as cola and energy drinks, yerba mate or guarana, will have similar dose-related effects on the breastfed infant. Coffee intake of more than 450 mL daily may decrease breastmilk iron concentrations and result in mild iron deficiency anemia in some breastfed infants.

Full LactMed record for caffeine: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised April 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about caffeine

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,559 reports naming caffeine, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

pemphigus1,021 reports
alopecia993 reports
hepatic enzyme increased991 reports
pericarditis988 reports
glossodynia972 reports
fatigue967 reports
rheumatoid arthritis964 reports
joint swelling963 reports

Read these as a signal, not a rate. A report does not mean caffeine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is caffeine?

Caffeine Citrate is a central nervous system stimulant used to treat Apnea, Fatigue.

What kind of drug is caffeine?

The FDA classifies caffeine as a central nervous system stimulant. CNS stimulants raise the levels of the brain's signaling chemicals dopamine and norepinephrine, either by releasing more of them or by blocking their reuptake. This heightened activity in attention and arousal circuits increases alertness, energy, and focus. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take caffeine with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run caffeine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is caffeine sold under?

We track 2 caffeine-containing products in the U.S.: Cafcit and Caffeine Citrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does caffeine come in?

Across the brands we track, caffeine is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic caffeine?

Yes. Our catalog lists 1 generic caffeine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has caffeine been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions caffeine. The most recent: Acetaminophen 500mg Caffeine 65mg caplets (Oct 17, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

What should I avoid while taking caffeine?

Other medicines: we hold source-cited interaction answers for Can you drink coffee while taking Adderall? and Can you take Excedrin and naproxen (Aleve) together?. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.

Cite this page

APA: pharmaranks. (2026, July 24). Caffeine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/caffeine
MLA: “Caffeine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/caffeine.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for caffeine on DailyMed (NIH) ↗.