Misoprostol (CYTOTEC Misoprostol 200 microgram tablet blister pack)
What to know about Misoprostol — also sold as CYTOTEC Misoprostol 200 microgram tablet blister pack, GyMiso misoprostol 200 microgram oral tablet blister pack, MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister]: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
Misoprostol (brand names: CYTOTEC Misoprostol 200 microgram tablet blister pack, GyMiso misoprostol 200 microgram oral tablet blister pack, MS-2 Step composite pack [MIFEPRISTONE LINEPHARMA 200 MG TABLET mifepristone 200 mg tablet blister; GyMiso misoprostol 200 microgram tablet blister]) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Prostaglandin E1 analogue with gastrointestinal side effects but minimal workplace safety impact.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (1 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Prostaglandin E1 analogue with gastrointestinal side effects but minimal workplace safety impact.
How Misoprostol is regulated
Misoprostol is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
WorkSafe Victoria Drugs of Dependence Guidelines require monitoring for all S8 opioids. WorkCover QLD Pain Intervention Guidelines recommend multimodal pain management with opioids as a last resort.
United Kingdom NICE / MHRA / FPM
NICE NG193 (Chronic Pain) recommends against initiating opioids for chronic primary pain. The Faculty of Pain Medicine (FPM) Opioids Aware resource recommends structured opioid prescribing with regular review, dose limits, and documented tapering plans.
For personal injury claims in the UK, opioid prescribing duration and dose should be reviewed against NICE and FPM guidelines. Costs may be recoverable as a disbursement in high-value PI claims.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL TABLETS WERE 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 ). MISOPROSTOL TABLETS 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. Misoprostol Tablets 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, Misoprostol Tablets 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 Misoprostol Tablets only on the second or third day of the next normal menstrual period.
The CDC Clinical Practice Guideline for Prescribing Opioids (2022) recommends non-opioid therapies as first-line treatment for pain. When opioids are prescribed, the lowest effective dose should be used for the shortest duration needed.
For workers compensation claims, many states require prior authorization for opioids beyond initial acute prescribing. State drug formularies (e.g. California MTUS, Texas, New York) may restrict or require step therapy before opioid approval.
New Zealand ACC / BPAC NZ / Medsafe
BPAC NZ recommends reassessing opioid therapy at regular intervals and limiting duration. The NZ Opioid Prescribing B-QuiCK Guide provides structured prescribing and tapering protocols.
ACC (Accident Compensation Corporation) covers treatment-related medications for accepted claims. Opioid prescribing beyond guidelines may require ACC clinical review and approval.
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.