Cytotec misoprostol 100 ug Tablet, 60-count — NDC 0025-1451-60 (Billing 00025-1451-60)
This is a package of 60 tablets of Cytotec misoprostol 100 ug Tablet from Pfizer Laboratories Div Pfizer Inc, marketed since Dec 1986 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0025-1451-60 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0025 labeler · 1451 product · 60 package
- Package marketed since
- Dec 27, 1986
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 60 EA per package
- Barcode (UPC)
- 0300251461606
- Medicaid fills, this package
- 34 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 015197
- GCN: 08251
- GPI-14 (Medi-Span): 49250030000310
- HICL (First Databank): 001187
- AHFS class code: 56:28.28.00
- RxCUI (RxNorm): 104098
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Prostaglandin E1 Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. It protects the stomach lining and decreases stomach acid secretion.
Read the full MedlinePlus article ↗- It lowers your risk of stomach ulcers caused by NSAIDs, including aspirin. It is for people at higher risk, such as older adults or those with a past ulcer. You take it for as long...
- Take it by mouth with a meal, generally four times a day, with the last dose at bedtime. Taking it after meals helps limit diarrhea. Follow your prescriber's directions.
- Diarrhea and belly pain are the most common, and diarrhea usually eases within about a week. Nausea, gas, headache and indigestion can also happen. Call your doctor if diarrhea is...
- No, not if you're pregnant. It can cause birth defects, abortion, premature birth and uterine rupture. If you could become pregnant, you'll need a negative pregnancy test and relia...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Misoprostol — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.4905 | $29.43 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $4.23 | $253.52 / 60 tablets |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00025-1451-34 0025-1451-34 | 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK | 1986-12-27 | — | Active |
| 00025-1451-60 You're viewing this Main listing | 60 TABLET in 1 BOTTLE, UNIT-DOSE | 1986-12-27 | — | Active |
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00025-1451-34?
What NDC number is used to bill for this package of Cytotec misoprostol 100 ug Tablet?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| misoprostol 100 ug 59762-5007-01 | Mylan | 60 tablets | $0.465 | AB | Availability likely | — |
| Misoprostol 100 ug 60687-0735-01 | American | 100 tablets | $0.465 | AB | Availability likely | — |
| Misoprostol 100 ug 70954-0443-10 | ANI | 60 tablets | $0.465 | AB | Availability likely | — |
| Misoprostol 100 ug 43386-0160-06 | Lupin | 60 tablets | $0.487 | — | FDA listed | — |
| Cytotec 100 ugthis 00025-1451-60 | Pfizer | 60 tablets | — | AB | FDA listed | — |
| Misoprostol 100 ug 40032-0160-06 | Novel | 60 tablets | — | — | FDA listed | — |
| Misoprostol 100 ug 42571-0253-12 | Micro | 120 tablets | — | — | Discontinued | — |
| Misoprostol 100 ug 68071-3762-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Misoprostol 100 ug 71335-2455-01 | Bryant | 28 tablets | — | AB | FDA listed | — |
| misoprostol 100 ug 71335-9631-01 | Bryant | 28 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Misoprostol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII ZF94AP8MEY
Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00025
- ABRILADA adalimumab-afzb Kit NDC 0025-0333-02
- Aldactone spironolactone 25 mg Tablet, Film Coated NDC 0025-1001-31
- Aldactone spironolactone 100 mg Tablet, Film Coated NDC 0025-1031-31
- Aldactone spironolactone 50 mg Tablet, Film Coated NDC 0025-1041-31
- Arthrotec diclofenac sodium and misoprostol 50 mg; 200 ug Tablet, Film Coated NDC 0025-1411-60
- Arthrotec diclofenac sodium and misoprostol 75 mg; 200 ug Tablet, Film Coated NDC 0025-1421-60
- Cytotec misoprostol 200 ug Tablet NDC 0025-1461-31
- Flagyl metronidazole 375 mg Capsule NDC 0025-1942-34
- Norpace CR disopyramide phosphate 100 mg Capsule, Extended Release NDC 0025-2732-31
- Norpace CR disopyramide phosphate 150 mg Capsule, Extended Release NDC 0025-2742-31
- Norpace disopyramide phosphate 100 mg Capsule, Gelatin Coated NDC 0025-2752-31
- Norpace disopyramide phosphate 150 mg Capsule, Gelatin Coated NDC 0025-2762-31
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNINGS CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (see also PRECAUTIONS and LABOR AND DELIVERY ).
CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Cytotec should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration.
In such patients, Cytotec may be prescribed if the patient • has had a negative serum pregnancy test within 2 weeks prior to beginning therapy. • is capable of complying with effective contraceptive measures. • has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake. • will begin Cytotec only on the second or third day of the next normal menstrual period.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cytotec (misoprostol) is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy.
Cytotec has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended adult oral dose of Cytotec for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies . ) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician.
Cytotec should be taken with a meal, and the last dose of the day should be at bedtime. Renal impairment Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology . )
⛔ Contraindications ▾
CONTRAINDICATIONS See boxed WARNINGS . Cytotec should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Cytotec should not be taken by anyone with a history of allergy to prostaglandins.
⚠️ Warnings ▾
WARNINGS See boxed WARNINGS . For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post-partum hemorrhage, which are outside of the approved indication.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following have been reported as adverse events in subjects receiving Cytotec: Gastrointestinal In subjects receiving Cytotec 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14–40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13–20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo.
Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of Cytotec (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if Cytotec is prescribed.
The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Cytotec with magnesium-containing antacids. Gynecological Women who received Cytotec during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to Cytotec administration.
If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (See boxed WARNINGS .) Elderly There were no significant differences in the safety profile of Cytotec in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients. Additional adverse events which were reported are categorized as follows: Incidence greater than 1% In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving Cytotec and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%).
However, there were no significant differences between the incidences of these events for Cytotec and placebo. Causal relationship unknown The following adverse events were infrequently reported. Causal relationships between Cytotec and these events have not been established but cannot be excluded: Body as a whole: aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes.
Skin: rash, dermatitis, alopecia, pallor, breast pain. Special senses: abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache. Respiratory: upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis.
Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA). Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase. Hypersensitivity: anaphylactic reaction Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase.
Genitourinary: polyuria, dysuria, hematuria, urinary tract infection. Nervous system/Psychiatric: anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion. Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain.
Blood/Coagulation: anemia, abnormal differential, thrombocytopenia, purpura, ESR increased.
🔄 Drug Interactions ▾
Drug interactions See Clinical Pharmacology . Cytotec has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Cytotec does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin.
Cytotec has no clinically significant effect on the kinetics of diclofenac or ibuprofen. Prostaglandins such as Cytotec may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended .
🤰 Pregnancy ▾
Pregnancy Teratogenic effects See boxed WARNINGS . Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient, but the drug's teratogenic mechanism has not been demonstrated. Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects.
Cytotec is not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human dose, respectively. Nonteratogenic effects See boxed WARNINGS . Cytotec may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman.
Cytotec may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by Cytotec may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID-induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus.
🧒 Pediatric Use ▾
Pediatric use Safety and effectiveness of Cytotec in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE The toxic dose of Cytotec in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system.
Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy. It is not known if misoprostol acid is dialyzable.
However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs. In normal volunteers, Cytotec (misoprostol) is rapidly absorbed after oral administration with a T max of misoprostol acid of 12 ± 3 minutes and a terminal half-life of 20–40 minutes.
There is high variability of plasma levels of misoprostol acid between and within studies but mean values after single doses show a linear relationship with dose over the range of 200–400 mcg. No accumulation of misoprostol acid was noted in multiple dose studies; plasma steady state was achieved within two days. Maximum plasma concentrations of misoprostol acid are diminished when the dose is taken with food and total availability of misoprostol acid is reduced by use of concomitant antacid.
Clinical trials were conducted with concomitant antacid, however, so this effect does not appear to be clinically important. Mean ± SD C max (pg/ml) AUC(0–4) (pg·hr/ml) T max (min) Fasting 811 ± 317 417 ± 135 14 ± 8 With Antacid 689 ± 315 349 ± 108 Comparisons with fasting results statistically significant, p<0.05. 20 ± 14 With High Fat Breakfast 303 ± 176 373 ± 111 64 ± 79 After oral administration of radiolabeled misoprostol, about 80% of detected radioactivity appears in urine.
Pharmacokinetic studies in patients with varying degrees of renal impairment showed an approximate doubling of T 1/2 , C max , and AUC compared to normals, but no clear correlation between the degree of impairment and AUC. In subjects over 64 years of age, the AUC for misoprostol acid is increased. No routine dosage adjustment is recommended in older patients or patients with renal impairment, but dosage may need to be reduced if the usual dose is not tolerated.
Drug interaction studies between misoprostol and several nonsteroidal anti-inflammatory drugs showed no effect on the kinetics of ibuprofen or diclofenac, and a 20% decrease in aspirin AUC, not thought to be clinically significant. Pharmacokinetic studies also showed a lack of drug interaction with antipyrine and propranolol when these drugs were given with misoprostol. Misoprostol given for 1 week had no effect on the steady state pharmacokinetics of diazepam when the two drugs were administered 2 hours apart.
The serum protein binding of misoprostol acid is less than 90% and is concentration-independent in the therapeutic range. After a single oral dose of misoprostol to nursing mothers, misoprostol acid was excreted in breast milk. The maximum concentration of misoprostol acid in expressed breast milk was achieved within 1 hour after dosing and was 7.6 pg/ml (CV 37%) and 20.9 pg/ml (CV 62%) after single 200 µg and 600 µg misoprostol administration, respectively.
The misoprostol acid concentrations in breast milk declined to < 1 pg/ml at 5 hours post-dose. Pharmacodynamics Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents.
Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 mcg and above that are also antisecretory. It is therefore not possible to tell whether the ability of misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both. In vitro studies on canine parietal cells using tritiated misoprostol acid as the ligand have led to the identification and characterization of specific prostaglandin receptors.
Receptor bindin… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one side and 1451 on the other side; supplied as: NDC Number Size 0025-1451-60 unit-of-use bottle of 60 Cytotec 200-mcg tablets are white, hexagonal, with SEARLE debossed above and 1461 debossed below the line on one side and a double stomach debossed on the other side; supplied as: NDC Number Size 0025-1461-60 unit-of-use bottle of 60 0025-1461-31 unit-of-use bottle of 100 0025-1461-34 carton of 100 unit dose Store at or below 25°C (77°F), in a dry area.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com .
📦 Storage and Handling ▾
Store at or below 25°C (77°F), in a dry area. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com .
📋 Description ▾
DESCRIPTION Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E 1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±): C 22 H 38 O 5 M.W. = 382.5 (±) methyl 11α, 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate.
Chemical Structure
💬 Information for Patients ▾
Information for patients Women of childbearing potential using Cytotec to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Cytotec therapy is initiated, and that they must use an effective contraception method while taking Cytotec. See boxed WARNINGS . Cytotec is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer.
Cytotec should be taken only according to the directions given by a physician. If the patient has questions about or problems with Cytotec, the physician should be contacted promptly. THE PATIENT SHOULD NOT GIVE CYTOTEC TO ANYONE ELSE.
Cytotec has been prescribed for the patient's specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she were to become pregnant. The Cytotec package the patient receives from the pharmacist will include a leaflet containing patient information. The patient should read the leaflet before taking Cytotec and each time the prescription is renewed because the leaflet may have been revised.
Keep Cytotec out of the reach of children. SPECIAL NOTE FOR WOMEN: Cytotec may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women. Cytotec is available only as a unit-of-use package that includes a leaflet containing patient information.
See Patient Information at the end of this labeling.
⚠️ Precautions ▾
PRECAUTIONS Caution should be employed when administering Cytotec (misoprostol) to patients with pre-existing cardiovascular disease. Information for patients Women of childbearing potential using Cytotec to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Cytotec therapy is initiated, and that they must use an effective contraception method while taking Cytotec. See boxed WARNINGS .
Cytotec is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer. Cytotec should be taken only according to the directions given by a physician. If the patient has questions about or problems with Cytotec, the physician should be contacted promptly.
THE PATIENT SHOULD NOT GIVE CYTOTEC TO ANYONE ELSE. Cytotec has been prescribed for the patient's specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she were to become pregnant. The Cytotec package the patient receives from the pharmacist will include a leaflet containing patient information.
The patient should read the leaflet before taking Cytotec and each time the prescription is renewed because the leaflet may have been revised. Keep Cytotec out of the reach of children. SPECIAL NOTE FOR WOMEN: Cytotec may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women.
Cytotec is available only as a unit-of-use package that includes a leaflet containing patient information. See Patient Information at the end of this labeling. Drug interactions See Clinical Pharmacology .
Cytotec has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Cytotec does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Cytotec has no clinically significant effect on the kinetics of diclofenac or ibuprofen.
Prostaglandins such as Cytotec may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended . Animal toxicology A reversible increase in the number of normal surface gastric epithelial cells occurred in the dog, rat, and mouse.
No such increase has been observed in humans administered Cytotec for up to 1 year. An apparent response of the female mouse to Cytotec in long-term studies at 100 to 1000 times the human dose was hyperostosis, mainly of the medulla of sternebrae. Hyperostosis did not occur in long-term studies in the dog and rat and has not been seen in humans treated with Cytotec.
Carcinogenesis, mutagenesis, impairment of fertility There was no evidence of an effect of Cytotec on tumor occurrence or incidence in rats receiving daily doses up to 150 times the human dose for 24 months. Similarly, there was no effect of Cytotec on tumor occurrence or incidence in mice receiving daily doses up to 1000 times the human dose for 21 months. The mutagenic potential of Cytotec was tested in several in vitro assays, all of which were negative.
Misoprostol, when administered to breeding male and female rats at doses 6.25 times to 625 times the maximum recommended human therapeutic dose, produced dose-related pre- and post-implantation losses and a significant decrease in the number of live pups born at the highest dose. These findings suggest the possibility of a general adverse effect on fertility in males and females. Pregnancy Teratogenic effects See boxed WARNINGS .
Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient, but the drug's teratogenic mechanism has not been demonstrated. Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defect… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing mothers Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. Caution should be exercised when misoprostol is administered to a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs. In normal volunteers, Cytotec (misoprostol) is rapidly absorbed after oral administration with a T max of misoprostol acid of 12 ± 3 minutes and a terminal half-life of 20–40 minutes.
There is high variability of plasma levels of misoprostol acid between and within studies but mean values after single doses show a linear relationship with dose over the range of 200–400 mcg. No accumulation of misoprostol acid was noted in multiple dose studies; plasma steady state was achieved within two days. Maximum plasma concentrations of misoprostol acid are diminished when the dose is taken with food and total availability of misoprostol acid is reduced by use of concomitant antacid.
Clinical trials were conducted with concomitant antacid, however, so this effect does not appear to be clinically important. Mean ± SD C max (pg/ml) AUC(0–4) (pg·hr/ml) T max (min) Fasting 811 ± 317 417 ± 135 14 ± 8 With Antacid 689 ± 315 349 ± 108 Comparisons with fasting results statistically significant, p<0.05. 20 ± 14 With High Fat Breakfast 303 ± 176 373 ± 111 64 ± 79 After oral administration of radiolabeled misoprostol, about 80% of detected radioactivity appears in urine.
Pharmacokinetic studies in patients with varying degrees of renal impairment showed an approximate doubling of T 1/2 , C max , and AUC compared to normals, but no clear correlation between the degree of impairment and AUC. In subjects over 64 years of age, the AUC for misoprostol acid is increased. No routine dosage adjustment is recommended in older patients or patients with renal impairment, but dosage may need to be reduced if the usual dose is not tolerated.
Drug interaction studies between misoprostol and several nonsteroidal anti-inflammatory drugs showed no effect on the kinetics of ibuprofen or diclofenac, and a 20% decrease in aspirin AUC, not thought to be clinically significant. Pharmacokinetic studies also showed a lack of drug interaction with antipyrine and propranolol when these drugs were given with misoprostol. Misoprostol given for 1 week had no effect on the steady state pharmacokinetics of diazepam when the two drugs were administered 2 hours apart.
The serum protein binding of misoprostol acid is less than 90% and is concentration-independent in the therapeutic range. After a single oral dose of misoprostol to nursing mothers, misoprostol acid was excreted in breast milk. The maximum concentration of misoprostol acid in expressed breast milk was achieved within 1 hour after dosing and was 7.6 pg/ml (CV 37%) and 20.9 pg/ml (CV 62%) after single 200 µg and 600 µg misoprostol administration, respectively.
The misoprostol acid concentrations in breast milk declined to < 1 pg/ml at 5 hours post-dose.
🧬 Pharmacodynamics ▾
Pharmacodynamics Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 mcg and above that are also antisecretory.
It is therefore not possible to tell whether the ability of misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both. In vitro studies on canine parietal cells using tritiated misoprostol acid as the ligand have led to the identification and characterization of specific prostaglandin receptors. Receptor binding is saturable, reversible, and stereospecific.
The sites have a high affinity for misoprostol, for its acid metabolite, and for other E type prostaglandins, but not for F or I prostaglandins and other unrelated compounds, such as histamine or cimetidine. Receptor-site affinity for misoprostol correlates well with an indirect index of antisecretory activity. It is likely that these specific receptors allow misoprostol taken with food to be effective topically, despite the lower serum concentrations attained.
Misoprostol produces a moderate decrease in pepsin concentration during basal conditions, but not during histamine stimulation. It has no significant effect on fasting or postprandial gastrin nor on intrinsic factor output.
🔬 Clinical Studies ▾
Clinical studies In a series of small short-term (about 1 week) placebo-controlled studies in healthy human volunteers, doses of misoprostol were evaluated for their ability to reduce the risk of NSAID-induced mucosal injury. Studies of 200 mcg q.i.d. of misoprostol with tolmetin and naproxen, and of 100 and 200 mcg q.i.d. with ibuprofen, all showed reduction of the rate of significant endoscopic injury from about 70–75% on placebo to 10–30% on misoprostol. Doses of 25–200 mcg q.i.d. reduced aspirin-induced mucosal injury and bleeding.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, mutagenesis, impairment of fertility There was no evidence of an effect of Cytotec on tumor occurrence or incidence in rats receiving daily doses up to 150 times the human dose for 24 months. Similarly, there was no effect of Cytotec on tumor occurrence or incidence in mice receiving daily doses up to 1000 times the human dose for 21 months. The mutagenic potential of Cytotec was tested in several in vitro assays, all of which were negative.
Misoprostol, when administered to breeding male and female rats at doses 6.25 times to 625 times the maximum recommended human therapeutic dose, produced dose-related pre- and post-implantation losses and a significant decrease in the number of live pups born at the highest dose. These findings suggest the possibility of a general adverse effect on fertility in males and females.
📄 Patient Package Insert ▾
PATIENT INFORMATION Read this leaflet before taking Cytotec ® (misoprostol) and each time your prescription is renewed, because the leaflet may be changed. Cytotec (misoprostol) is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to the arthritis/pain medication that you take. Do not take Cytotec to reduce the risk of NSAID-induced ulcers if you are pregnant.
(See boxed WARNINGS .) Cytotec can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Cytotec may cause the uterus to tear (uterine rupture) during pregnancy.
The risk of uterine rupture increases as your pregnancy advances and if you have had surgery on the uterus, such as a Cesarean delivery. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death. If you become pregnant during Cytotec therapy, stop taking Cytotec and contact your physician immediately.
Remember that even if you are on a means of birth control it is still possible to become pregnant. Should this occur, stop taking Cytotec and contact your physician immediately. Cytotec may cause diarrhea, abdominal cramping, and/or nausea in some people.
In most cases these problems develop during the first few weeks of therapy and stop after about a week. You can minimize possible diarrhea by making sure you take Cytotec with food. Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take Cytotec.
If you have prolonged difficulty (more than 8 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor. Take Cytotec only according to the directions given by your physician. Do not give Cytotec to anyone else.
It has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant. This information sheet does not cover all possible side effects of Cytotec. This patient information leaflet does not address the side effects of your arthritis/pain medication.
See your doctor if you have questions. Keep out of reach of children. This product's labeling may have been updated.
For the most recent prescribing information, please visit www.pfizer.com . LAB-0172-5.0 Revised February 2025 A close-up of a company logo Description automatically generated
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 100 mcg Tablet Bottle Label Pfizer NDC 0025-1451-60 Cytotec ® misoprostol tablets 100 mcg 60 Tablets Distributed by Pfizer Labs Division of Pfizer Inc, New York, NY 10001 Rx only PRINCIPAL DISPLAY PANEL - 100 mcg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 200 mcg Tablet Blister Pack NDC 0025-1461-34 Cytotec ® misoprostol tablets 200 mcg Distributed by G.D. Searle LLC Division of Pfizer Inc. NY, NY 10017 EXP: YYYY.MM.DD LOT A01234 21540995 PRINCIPAL DISPLAY PANEL - 200 mcg Tablet Blister Pack
PRINCIPAL DISPLAY PANEL - 200 mcg Tablet Blister Pack Carton Pfizer Cytotec ® 200 mcg misoprostol tablets 100 Tablets For in-institution use only PRINCIPAL DISPLAY PANEL - 200 mcg Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 200 mcg Tablet Bottle Label Pfizer NDC 0025-1461-60 Cytotec ® misoprostol tablets 200 mcg 60 Tablets Distributed by Pfizer Labs Division of Pfizer Inc, New York, NY 10001 Rx only PRINCIPAL DISPLAY PANEL - 200 mcg Tablet Bottle Label
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