Angusta (Misoprostol): Uses, Dosage & Side Effects
A prostaglandin E1 analogue used in hospitals to induce labor from 37 weeks of pregnancy by softening the cervix and stimulating uterine contractions
Angusta is a brand-name formulation of misoprostol (25 micrograms) specifically developed and licensed for the induction of labor at term (from 37 weeks of pregnancy onward). Misoprostol is a synthetic prostaglandin E1 analogue that softens and ripens the cervix while stimulating uterine contractions, thereby helping to initiate the birth process when there is a medical need to start labor. Angusta is administered orally in a hospital setting under continuous fetal monitoring by trained healthcare professionals. It is approved throughout the European Economic Area and recommended by the WHO as a preferred option for labor induction.
Quick Facts: Angusta
Key Takeaways
- Angusta contains misoprostol 25 mcg and is the first oral misoprostol formulation specifically licensed in Europe for labor induction from 37 weeks of pregnancy; it is recommended by the WHO as a preferred method for cervical ripening and labor induction.
- It must only be administered by trained healthcare professionals in a hospital with fetal monitoring equipment; the maximum dose is 200 mcg over 24 hours, and treatment is stopped once active labor begins.
- Angusta is contraindicated if labor has already started, if you have had previous uterine surgery (including cesarean section), if the baby is in an abnormal position, or if other labor-inducing medications are being given concurrently.
- The most common side effects include nausea, vomiting, postpartum hemorrhage, and meconium-stained amniotic fluid; uterine hyperstimulation can occur but is managed by the attending medical team.
- When used as directed from 37 weeks onward, Angusta has been shown in clinical trials to be as effective as vaginal dinoprostone with comparable neonatal outcomes; it should not be used at any other stage of pregnancy as misoprostol can cause harm to the developing baby.
What Is Angusta and What Is It Used For?
Angusta is the brand name for a formulation of misoprostol that has been specifically developed, studied, and licensed for the induction of labor at term. While misoprostol has been available since the 1980s under other brand names (most notably Cytotec, which was originally developed for gastric ulcer prevention), Angusta is notable for being the first misoprostol product to receive regulatory approval in Europe specifically for obstetric use in labor induction. It was authorized by the European Medicines Agency (EMA) through the decentralized procedure and is approved in all EU/EEA member states.
The active ingredient, misoprostol, belongs to a class of medications called prostaglandins. Prostaglandins are naturally occurring hormone-like substances that play a central role in the onset and progression of labor. They perform two critical functions during childbirth. First, they promote cervical ripening – the process by which the cervix softens, thins (effaces), and begins to dilate, allowing the baby to pass through the birth canal. Second, they stimulate contractions of the uterine smooth muscle (myometrium), generating the rhythmic contractions that are essential for pushing the baby out of the uterus during labor.
Misoprostol exerts these effects by binding to prostaglandin EP2 and EP3 receptors on the surface of cells in the cervix and uterine muscle. When it binds to these receptors in the cervix, it triggers a cascade of biochemical changes including increased collagenase activity and alterations in the composition of the extracellular matrix, resulting in softening and dilation. In the myometrium, receptor activation leads to an increase in intracellular calcium concentration, which in turn triggers smooth muscle contraction. The combined effect of cervical ripening and myometrial stimulation makes misoprostol a highly effective agent for labor induction.
After oral administration, misoprostol is rapidly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism to its pharmacologically active metabolite, misoprostol acid. Peak plasma concentrations of misoprostol acid are achieved within approximately 12 minutes after oral dosing. The oral bioavailability is around 80%, and the elimination half-life of the active metabolite is short, approximately 20 to 40 minutes. This rapid onset and short half-life are clinically advantageous because they allow for precise dose titration and relatively quick offset of effect if treatment needs to be discontinued.
There are many medical reasons why induction of labor may be recommended. These include pregnancies that have gone past the due date (post-term pregnancy, typically beyond 41–42 weeks), pre-eclampsia or other hypertensive disorders of pregnancy, gestational diabetes with complications, premature rupture of membranes without spontaneous onset of labor, intrauterine growth restriction, oligohydramnios (reduced amniotic fluid), and various other maternal or fetal conditions where the benefits of delivery outweigh the risks of continuing the pregnancy. The decision to induce labor is always made by the attending obstetrician or midwife after careful assessment of both maternal and fetal wellbeing.
Before Angusta became available, clinicians often used off-label misoprostol formulations (such as Cytotec 200 mcg tablets cut into smaller pieces) for labor induction. This practice, while widely accepted and supported by WHO guidelines, had limitations: imprecise dosing from tablet cutting, use of a product not specifically studied or licensed for obstetric use, and variable bioavailability. Angusta addresses these issues by providing a precisely manufactured 25 mcg tablet that has been through rigorous clinical trials specifically for labor induction, ensuring consistent dosing and a well-characterized safety profile in the obstetric population.
What Should You Know Before Taking Angusta?
Contraindications
Angusta must not be used in the following situations. Your obstetrician or midwife will carefully assess you before administering this medication to ensure none of these contraindications apply.
- Allergy to misoprostol: Do not take Angusta if you are allergic to misoprostol or any of the other ingredients in this medicine (hypromellose, microcrystalline cellulose, maize starch, crospovidone, croscarmellose sodium, anhydrous colloidal silicon dioxide).
- Labor has already started: Angusta should not be given once spontaneous labor contractions have begun, as it could lead to excessive uterine stimulation.
- Fetal distress: If the baby shows signs of compromise or stress (e.g., abnormal heart rate patterns on cardiotocography), Angusta must not be administered.
- Concurrent use of other labor-inducing drugs: Angusta must not be used at the same time as oxytocin or any other prostaglandin preparation used for labor induction or cervical ripening (such as dinoprostone). A minimum interval of 4 hours after the last dose of Angusta must be observed before oxytocin can be started.
- Previous uterine surgery: This is a critical contraindication. Angusta must not be used in women who have had previous surgery on the cervix or uterus, including cesarean section. The use of prostaglandins in the presence of a uterine scar significantly increases the risk of uterine rupture, a rare but potentially life-threatening emergency.
- Abnormal uterine anatomy: Women with structural uterine abnormalities (such as bicornuate uterus) that would prevent vaginal delivery should not receive Angusta.
- Placenta praevia: If the placenta is covering or partially covering the cervical opening (birth canal), or if there has been unexplained vaginal bleeding after 24 weeks of pregnancy, Angusta is contraindicated.
- Abnormal fetal presentation: If the baby is not in a head-down (cephalic) position – for example, in a breech or transverse lie – Angusta should not be used, as vaginal delivery may not be possible.
- Severe renal impairment: Angusta is contraindicated in women with a glomerular filtration rate below 15 ml/min/1.73 m².
Warnings and Precautions
Angusta must only be administered by trained healthcare professionals in a hospital or birthing facility equipped with continuous fetal monitoring (cardiotocography) and the ability to perform emergency cesarean section if needed. The cervix will be carefully examined before treatment begins. Do not take this medication outside of a supervised medical setting.
Important warnings and precautions that your medical team will consider before and during treatment with Angusta include:
- Uterine hyperstimulation: Angusta can cause excessive stimulation of the uterus, resulting in contractions that are too strong (hypertonic), too frequent (tachysystole), or too prolonged. If hyperstimulation occurs, no further doses will be given, and the medical team will determine whether tocolytic medication (drugs that relax the uterus) is needed or whether emergency delivery is required.
- Severe pre-eclampsia: The effects of Angusta have not been specifically studied in women with severe pre-eclampsia (a condition characterized by dangerously high blood pressure, protein in the urine, and sometimes other complications during pregnancy). Your doctor will weigh the risks and benefits carefully.
- Chorioamnionitis: In cases of infection of the fetal membranes, rapid delivery may be necessary. Your doctor will make all necessary decisions regarding antibiotic treatment, labor induction, or cesarean section.
- Prolonged rupture of membranes: There is limited experience with using Angusta in women whose membranes have been ruptured for more than 48 hours before treatment.
- Oxytocin timing: If your doctor determines that oxytocin treatment is needed after Angusta, a minimum waiting period of 4 hours after the last dose of Angusta is recommended, as both drugs can stimulate uterine contractions and their combined effect could be excessive.
- Multiple pregnancy: There is no experience with the use of Angusta for labor induction in women carrying more than one baby (twins, triplets, etc.).
- Grand multiparity: There is no experience with the use of Angusta in women who have previously given birth to 5 or more children vaginally, who may be at increased risk of uterine complications.
- Preterm induction: There is limited experience with the use of Angusta before 37 weeks of pregnancy.
- Bishop score: There is limited information on the use of Angusta in women with a Bishop score higher than 6 (the Bishop score is the standard method for assessing cervical readiness for labor).
- Disseminated intravascular coagulation (DIC): An increased risk of DIC (a serious blood clotting disorder) has been observed following induced labor, regardless of the method used.
- Renal or hepatic impairment: Dose adjustments (lower dose and/or longer intervals between doses) may be necessary in pregnant women with impaired kidney or liver function.
Angusta tablets contain less than 1 mmol of sodium (23 mg) per tablet, meaning they are essentially sodium-free. This is relevant for patients on sodium-restricted diets.
Pregnancy and Breastfeeding
Angusta is specifically designed and licensed for use during pregnancy – specifically for the induction of labor from 37 weeks of gestation onward. When used at this stage of pregnancy for its approved indication, Angusta has been extensively studied and is not associated with harm to the baby. Clinical trials have demonstrated that neonatal outcomes (including Apgar scores, rates of neonatal intensive care admission, and perinatal complications) are comparable between babies born after Angusta-induced labor and those born after labor induced by other approved methods.
Angusta must not be used at any point during pregnancy other than for labor induction from 37 weeks onward. Misoprostol is known to cause uterine contractions at any stage of pregnancy and can cause miscarriage, premature birth, or birth defects if taken earlier in pregnancy. If you are pregnant and not yet at term, do not take this medication.
Regarding breastfeeding, misoprostol and its active metabolite may be excreted in breast milk in small amounts. However, given the very short half-life of the drug (20–40 minutes) and the fact that it is typically administered hours before delivery, the amount present in breast milk by the time breastfeeding is established is expected to be negligible. Breastfeeding can be initiated 4 hours after the last dose of Angusta. There are no reports of adverse effects in breastfed infants of mothers who received misoprostol for labor induction.
The use of Angusta for labor induction from 37 weeks of pregnancy does not affect future fertility. There is no evidence from clinical trials or post-marketing surveillance that a single course of misoprostol for labor induction has any lasting effect on reproductive function.
How Does Angusta Interact with Other Drugs?
Because Angusta is administered in a controlled hospital setting for a specific and short-duration indication (labor induction), the number of clinically relevant drug interactions is relatively limited compared to medications taken on an outpatient basis. However, several important interactions must be considered by the healthcare team managing your labor.
Major Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Oxytocin (Syntocinon, Pitocin) | Both oxytocin and misoprostol stimulate uterine contractions. Concurrent use can lead to severe uterine hyperstimulation, which may cause uterine rupture, fetal distress, or placental abruption. | Angusta and oxytocin must never be administered simultaneously. A minimum interval of 4 hours after the last dose of Angusta must be observed before starting oxytocin infusion. This is an absolute contraindication. |
| Dinoprostone (Cervidil, Propess, Prostin E2) | Dinoprostone is another prostaglandin used for cervical ripening. Combining two prostaglandins can cause additive uterine stimulation, greatly increasing the risk of hyperstimulation and related complications. | Do not use Angusta concurrently with dinoprostone or any other prostaglandin preparation. If switching from one agent to another, allow an appropriate washout period as determined by the attending obstetrician. |
| Other prostaglandins (e.g., carboprost, gemeprost) | Any prostaglandin or prostaglandin analogue used for obstetric purposes will have additive uterotonic effects when combined with misoprostol, increasing the risk of uterine hyperstimulation. | Do not combine Angusta with any other prostaglandin preparation. Only one method of pharmacological labor induction should be used at a time. |
Minor Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| NSAIDs (e.g., ibuprofen, naproxen, diclofenac) | Non-steroidal anti-inflammatory drugs inhibit prostaglandin synthesis and could theoretically attenuate the cervical ripening and uterotonic effects of misoprostol. | NSAIDs are generally avoided during the third trimester of pregnancy for other reasons (premature closure of the ductus arteriosus). This interaction is rarely clinically relevant in the labor induction context. |
| Antacids containing magnesium | Magnesium-containing antacids may worsen the diarrhea that can be caused by misoprostol, though this is primarily relevant with higher doses used in gastric protection rather than the low doses used for labor induction. | If antacid use is necessary, consider an aluminium-based or calcium-based antacid instead. Inform your healthcare team of all medications you are taking. |
| Magnesium sulfate | Magnesium sulfate, used for pre-eclampsia seizure prophylaxis, has tocolytic properties that may partially counteract the uterotonic effect of misoprostol. | When both medications are needed concurrently, the obstetric team will closely monitor labor progress and adjust dosing as needed. This combination requires careful clinical judgment. |
Always inform your midwife, obstetrician, or nurse about all medications you are currently taking or have recently taken, including over-the-counter medicines, vitamins, and herbal supplements. While drug interactions in the acute labor induction setting are limited, your healthcare team needs a complete medication history to ensure safe care for you and your baby.
What Is the Correct Dosage of Angusta?
Angusta dosing is always determined and managed by trained healthcare professionals in a hospital setting. You will not need to decide on your own dose – this will be carefully calculated and monitored by your obstetric team. The cervix will be examined before treatment begins, and both you and your baby will be continuously monitored throughout the induction process.
Standard Dosing Regimens
Approved Dosing Schedules
Regimen 1: 25 micrograms (one tablet) orally every 2 hours
Regimen 2: 50 micrograms (two tablets) orally every 4 hours
Administration: Swallow the tablet(s) with a glass of water. The tablet should not be split or crushed.
Maximum dose: 200 micrograms in any 24-hour period
| Parameter | Regimen 1 (25 mcg q2h) | Regimen 2 (50 mcg q4h) |
|---|---|---|
| Single dose | 25 mcg (1 tablet) | 50 mcg (2 tablets) |
| Dosing interval | Every 2 hours | Every 4 hours |
| Max daily dose | 200 mcg (8 tablets) | 200 mcg (4 doses of 2 tablets) |
| Nausea/vomiting rate | Common | Very common |
| Postpartum hemorrhage | Very common | Common |
When Treatment Is Stopped
Your midwife or obstetrician will stop Angusta treatment under any of the following circumstances:
- The maximum dose of 200 micrograms has been administered over a 24-hour period
- Active labor has begun (regular, effective contractions with progressive cervical dilation)
- Contractions become too strong, too frequent, or too prolonged (uterine hyperstimulation)
- Signs of fetal distress are detected on the cardiotocograph (CTG) monitor
- A decision is made to start oxytocin or another labor-inducing agent (a 4-hour waiting period after the last dose of Angusta is recommended before starting oxytocin)
- A decision is made to proceed to cesarean section for any clinical reason
Renal or Hepatic Impairment
Dose adjustments may be necessary in pregnant women with impaired kidney or liver function. Misoprostol is primarily metabolized by the liver through fatty acid oxidation, and its metabolites are excreted by the kidneys. In women with significant renal impairment, the clearance of misoprostol acid may be reduced, leading to higher plasma concentrations and a prolonged duration of action. Similarly, severe hepatic impairment may affect the first-pass metabolism of misoprostol. Your obstetric team will determine the appropriate dose and dosing interval based on your individual clinical situation.
Adolescents
The use of Angusta has not been specifically studied in pregnant women younger than 18 years of age. However, the pharmacology of misoprostol would not be expected to differ significantly in adolescents compared to adults. Clinical decisions regarding labor induction in adolescent pregnancies should be made on an individual basis by an experienced obstetrician.
Overdose
If an overdose of Angusta is suspected, contact your medical team immediately. In a hospital setting, overdose management will be directed by the attending physicians.
An overdose of Angusta could cause excessively strong or prolonged uterine contractions (uterine hyperstimulation), which may lead to fetal distress and compromise. Since Angusta is administered in a hospital setting under continuous monitoring, overdose is unlikely. However, if it occurs, the medical team will immediately discontinue the medication. Tocolytic agents (medications that relax the uterine muscle, such as terbutaline) may be administered to counteract the excessive contractions. If fetal distress persists despite treatment, emergency cesarean section may be necessary. There is no specific antidote for misoprostol, and management is supportive and symptomatic.
What Are the Side Effects of Angusta?
Like all medicines, Angusta can cause side effects, although not everyone will experience them. Because Angusta is administered in a hospital with continuous monitoring, the medical team is prepared to detect and manage any adverse effects promptly. The following side effects have been reported in clinical trials and post-marketing experience, classified by frequency. Some side effects differ in frequency between the two approved dosing regimens (25 mcg every 2 hours versus 50 mcg every 4 hours).
Very Common
- Nausea: Reported as very common with the 50 mcg every 4 hours regimen; common with the 25 mcg every 2 hours regimen
- Vomiting: Reported as very common with the 50 mcg every 4 hours regimen; common with the 25 mcg every 2 hours regimen
- Meconium-stained amniotic fluid: The baby may pass stool (meconium) into the amniotic fluid before birth; while often benign, it requires monitoring for meconium aspiration
- Postpartum hemorrhage: Blood loss greater than 500 ml after delivery; reported as very common with the 25 mcg every 2 hours regimen; common with the 50 mcg every 4 hours regimen
Common
- Low Apgar score (baby): A test performed on the baby at 1 and 5 minutes after birth that indicates the baby’s condition; reported at varying frequency between dosing regimens
- Abnormal fetal heart rate (baby): Changes in the baby’s heart rate pattern detected on the cardiotocograph (CTG) monitor
- Uterine hyperstimulation: Contractions that are too strong, too frequent, or too prolonged, with or without changes in fetal heart rate; managed by stopping treatment and potentially administering tocolytic medication
- Diarrhea: Typically mild and self-limiting
- Chills: Shivering or feeling cold, a recognized prostaglandin side effect
- Fever: Mild temperature elevation, usually transient
Uncommon
- Low Apgar score (baby): Reported as uncommon with the 50 mcg every 4 hours regimen specifically
- Abnormal fetal heart rate (baby): Reported as uncommon with the 50 mcg every 4 hours regimen specifically
Frequency Not Known
- Dizziness: Feeling lightheaded or unsteady
- Seizures (baby): Neonatal seizures occurring during or shortly after delivery
- Hypoxic-ischemic encephalopathy (baby): Oxygen deprivation to the baby’s brain and organs during labor
- Neonatal cyanosis (baby): Bluish discoloration of the skin and mucous membranes in the newborn due to low blood oxygen
- Itchy rash: Pruritic skin eruption in the mother
- Fetal acidosis (baby): Elevated acid levels in the baby’s blood, indicating compromise
- Placental abruption: Premature separation of the placenta from the uterine wall before delivery, which can cause severe bleeding and fetal compromise
- Uterine rupture: A rare but serious tearing of the uterine wall, requiring emergency cesarean section; risk is highest in women with a previous uterine scar (which is a contraindication for Angusta use)
While you are being monitored in hospital, alert your midwife, nurse, or doctor immediately if you experience: sudden severe abdominal pain that does not subside between contractions; dizziness or feeling faint; heavy vaginal bleeding; difficulty breathing; a feeling that something is wrong. These could be signs of a serious complication requiring immediate intervention.
It is important to understand that some of the side effects listed above (such as meconium-stained amniotic fluid, abnormal fetal heart rate, and postpartum hemorrhage) can also occur during spontaneous (non-induced) labor. Clinical trials comparing Angusta with other methods of labor induction (such as vaginal dinoprostone) have shown similar rates of these outcomes. The attending medical team will be monitoring you and your baby continuously and will intervene promptly if any complications arise.
If you experience any side effects not listed here, or if you have concerns about symptoms you are experiencing during or after treatment with Angusta, discuss them with your healthcare team. Adverse effects related to medicines can be reported to your national pharmacovigilance authority, such as the MHRA Yellow Card scheme in the UK, the FDA MedWatch program in the US, or the EMA EudraVigilance system in Europe.
How Should You Store Angusta?
Proper storage ensures that Angusta tablets remain effective and safe. As a hospital-administered medication, storage is typically managed by the pharmacy department, but the following information is relevant for all settings:
- Original packaging: Store Angusta in its original blister packaging to protect the tablets from moisture. Misoprostol is sensitive to humidity, and exposure to moisture can reduce the potency of the tablets.
- Temperature: No special temperature storage conditions are required beyond normal room temperature. Do not freeze.
- Child safety: Keep this medicine out of the sight and reach of children. Although Angusta is a hospital medication, any remaining tablets should be stored securely.
- Expiry date: Do not use Angusta after the expiry date stated on the blister foil and carton (marked “EXP”). The expiry date refers to the last day of the stated month.
- Disposal: Do not dispose of medicines down the drain or with household waste. Return any unused or expired medicine to your pharmacist for safe, environmentally responsible disposal.
Angusta tablets are supplied in blister packs containing 8 tablets per carton. Each tablet is a white, uncoated, oval tablet measuring 7.5 × 4.5 mm with a score line on one side and a smooth surface on the other. The score line is not intended for splitting the tablet – the whole tablet should always be swallowed intact.
What Does Angusta Contain?
Understanding the full composition of Angusta is important for identifying potential allergens or excipients to which you may be sensitive. The formulation has been designed for consistent drug release and stability.
Active Ingredient
Misoprostol 25 micrograms per tablet. Misoprostol is a synthetic analogue of prostaglandin E1 (PGE1). It is a white to off-white, viscous liquid in its pure form but is incorporated into a solid tablet matrix for oral administration. The 25 microgram dose was specifically selected for labor induction based on extensive clinical trial data demonstrating an optimal balance between efficacy (successful labor induction) and safety (minimizing the risk of uterine hyperstimulation).
Inactive Ingredients (Excipients)
The following inactive ingredients serve various pharmaceutical functions in the tablet formulation:
- Hypromellose (HPMC): A cellulose-derived polymer used as a binder and film-forming agent to help maintain tablet integrity and control drug release.
- Microcrystalline cellulose: A widely used pharmaceutical excipient that serves as a binder and filler, providing bulk and mechanical strength to the tablet.
- Maize starch (corn starch): Used as a filler and disintegrant, helping the tablet to break down after swallowing to allow the active ingredient to be absorbed.
- Crospovidone: A superdisintegrant that promotes rapid tablet disintegration in the gastrointestinal tract, facilitating fast absorption of misoprostol.
- Croscarmellose sodium: Another superdisintegrant that works in conjunction with crospovidone to ensure efficient tablet break-up and drug release.
- Anhydrous colloidal silicon dioxide: A flow agent (glidant) used during the manufacturing process to improve powder flow and ensure uniform tablet content.
Angusta tablets do not contain lactose, sucrose, gluten, or any animal-derived ingredients. If you have known allergies to any pharmaceutical excipients, inform your healthcare team before treatment. The marketing authorization holder for Angusta is Norgine B.V. (Amsterdam, Netherlands), and the product is manufactured under strict Good Manufacturing Practice (GMP) standards.
Frequently Asked Questions About Angusta
Angusta is used specifically for the induction of labor from 37 weeks of pregnancy onward. It contains misoprostol, a synthetic prostaglandin E1 analogue that softens and ripens the cervix and stimulates uterine contractions. Labor induction may be recommended for various medical reasons, including post-term pregnancy (going past the due date), pre-eclampsia, gestational diabetes with complications, premature rupture of membranes, or other conditions where continuing the pregnancy poses risks to the mother or baby. The decision to induce labor is always made by the attending obstetrician or midwife after careful assessment.
Angusta is taken orally as a tablet swallowed with a glass of water. Unlike some other labor induction methods that involve vaginal insertion (such as dinoprostone pessaries), Angusta is administered by mouth, which many women find more comfortable and less invasive. Two dosing schedules are approved: 25 micrograms (one tablet) every 2 hours, or 50 micrograms (two tablets) every 4 hours. The maximum total dose is 200 micrograms in 24 hours. Treatment takes place in a hospital with continuous fetal monitoring. Your medical team will assess your response and decide when to continue, adjust, or stop the medication.
No, Angusta must not be used in women who have had previous surgery on the uterus, including cesarean section. This is one of the most important contraindications. The presence of a surgical scar on the uterus increases the risk of uterine rupture during prostaglandin-induced contractions, which is a rare but serious and potentially life-threatening complication for both mother and baby. Women with a previous cesarean section who require labor induction may be offered alternative methods such as mechanical cervical ripening with a balloon catheter, or may be recommended for repeat cesarean section. This decision is made on an individual basis by the obstetrician.
The most commonly reported side effects of Angusta include nausea, vomiting, postpartum hemorrhage (excessive bleeding after delivery), and meconium-stained amniotic fluid (the baby passing stool into the amniotic fluid before birth). Other common side effects include uterine hyperstimulation (contractions that are too strong or too frequent), diarrhea, chills, and fever. The frequency of some side effects varies between the two approved dosing regimens. Importantly, many of these effects (such as postpartum hemorrhage and meconium staining) can also occur during spontaneous labor. Your medical team is trained to monitor for and manage all potential complications.
When used as directed from 37 weeks of pregnancy onward, Angusta has been demonstrated in clinical trials to be safe for the baby. Neonatal outcomes including Apgar scores, rates of neonatal intensive care admission, and perinatal complications have been shown to be comparable between Angusta-induced labor and labor induced by other approved methods (such as vaginal dinoprostone). However, as with any method of labor induction, there is a small risk of fetal distress or hyperstimulation, which is why continuous fetal heart rate monitoring is mandatory throughout treatment. The medical team will discontinue Angusta and intervene immediately if any signs of fetal compromise are detected.
Angusta (oral misoprostol 25 mcg) has been extensively compared with other labor induction methods in clinical trials and systematic reviews. A 2021 Cochrane systematic review found that low-dose oral misoprostol is at least as effective as vaginal dinoprostone (the previous standard of care in many countries) for achieving vaginal delivery within 24 hours, with comparable cesarean section rates and neonatal outcomes. The WHO recommends low-dose oral misoprostol as a preferred option for labor induction. Key advantages of oral misoprostol include its oral route of administration (avoiding vaginal examination for drug placement), room-temperature storage, lower cost compared to dinoprostone formulations, and the ability to give precise, titrated doses. Angusta specifically adds the benefit of a purpose-manufactured 25 mcg tablet, eliminating the dosing uncertainty associated with cutting larger misoprostol tablets.
References
This article is based on current international medical guidelines, regulatory documents, and peer-reviewed research. All sources meet evidence level 1A standards.
- World Health Organization (WHO). WHO Recommendations for Induction of Labour. Geneva: WHO; 2022. Recommends low-dose oral misoprostol as a preferred method for labor induction at term.
- European Medicines Agency (EMA). Angusta (misoprostol) – Summary of Product Characteristics. EMA; 2025. Comprehensive regulatory document covering approved indications, dosing, contraindications, and safety data for labor induction.
- International Federation of Gynecology and Obstetrics (FIGO). Misoprostol Recommendations. FIGO; 2022. International guidelines on the use of misoprostol in obstetrics and gynecology.
- National Institute for Health and Care Excellence (NICE). Inducing Labour (NICE Guideline NG207). NICE; 2021 (updated 2023). Evidence-based UK guidance on methods and monitoring for labor induction.
- American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 107: Induction of Labor. Obstet Gynecol. 2009;114(2 Pt 1):386-397. (Reaffirmed 2023). US national guidelines on labor induction methods and monitoring.
- Alfirevic Z, Keeney E, Dowswell T, et al. Methods to induce labour: a systematic review, network meta-analysis and cost-effectiveness analysis. BJOG. 2016;123(9):1462-1470. doi:10.1111/1471-0528.13981
- Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021;6(6):CD014484. doi:10.1002/14651858.CD014484
- Weeks AD, Navaratnam K, Alfirevic Z. Misoprostol for induction of labour: a review. Best Pract Res Clin Obstet Gynaecol. 2022;77:54-65. Comprehensive review of misoprostol pharmacology and clinical evidence for labor induction.
- Tang OS, Schweer H, Seyberth HW, Lee SWH, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002;17(2):332-336. doi:10.1093/humrep/17.2.332
- Norgine B.V. Angusta 25 microgram tablets – Patient Information Leaflet. Amsterdam: Norgine B.V.; 2025. Official patient information for the licensed product.
Editorial Team
This article has been written and reviewed by the iMedic medical editorial team according to our strict editorial standards. Our team consists of licensed physicians, pharmacists, and medical researchers with expertise in obstetrics, gynecology, and clinical pharmacology.
Content developed by iMedic's medical writing team based on current international guidelines (WHO, EMA, FIGO, ACOG, NICE) and peer-reviewed obstetric and pharmacological research.
Independently reviewed and fact-checked by the iMedic Medical Review Board, comprising board-certified specialists in obstetrics, maternal medicine, and clinical pharmacology.
All medical claims are supported by Level 1A evidence (systematic reviews, meta-analyses, and randomized controlled trials) following the GRADE evidence framework.
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