Applies to carboprost: intramuscular solution.

Serious side effects of Carboprost

Along with its needed effects, carboprost may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking carboprost:

Less common or rare

• Fast or slow heartbeat
• headache (severe and continuing)
• hives or skin rash
• increased pain of the uterus
• pale, cool, blotchy skin on arms or legs
• pressing or painful feeling in chest
• shortness of breath
• swelling of face, inside the nose, and eyelids
• tightness in chest
• trouble in breathing
• weak or absent pulse in arms or legs
• wheezing

Check with your doctor as soon as possible if any of the following side effects occur while taking carboprost:

• Constipation
• pain or inflammation at place of injection
• tender or mildly bloated abdomen or stomach

Other side effects of Carboprost

Some side effects of carboprost may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• nausea
• vomiting

Less common or rare

• Chills or shivering
• dizziness
• fever (temporary)
• flushing or redness of face
• headache
• stomach cramps or pain

This procedure may result in some effects, which occur after the procedure is completed, that need medical attention. Check with your doctor if you notice any of the following:

• Chills or shivering (continuing)
• fever (continuing)
• foul-smelling vaginal discharge
• increase in uterus bleeding
• pain in lower abdomen

For Healthcare Professionals

Applies to carboprost: injectable solution.

General

-Contractile effect on smooth muscle, nausea, vomiting, diarrhea, increased temperature and flushing are the most frequent adverse reactions observed.

-Adverse effects of this drug are generally transient and reversible when therapy ends.

-Endometritis, retained placental fragments, and excessive uterine bleeding were the most common complications after discharge from the hospital.^[Ref]

Transient pyrexia may be due to the effect of carboprost on hypothalamic thermoregulation. Temperature elevation exceeding 2 degrees Fahrenheit have been reported in approximately 12.5% of the patients who received the recommended dosage regimen. In all cases, temperature returned to normal when therapy ended.^[Ref]

Gastrointestinal

Pretreatment or concurrent administration of antiemetic and antidiarrheal drugs considerably decreases the very high incidence of gastrointestinal side effects that are common with all prostaglandins used for abortion.^[Ref]

Very common (10% or more): Vomiting and diarrhea (66%), nausea (33%)

Uncommon (0.1% to 1%): Hematemesis, upper abdominal pain, dry mouth

Frequency not reported: Epigastric pain, excessive thirst, taste alterations, gagging

Postmarketing reports: Retching^[Ref]

Other

Very common (10% or more): Body temperature increased (12%)

Uncommon (0.1% to 1%): Vertigo, tinnitus

Frequency not reported: Retained placental fragment

Postmarketing reports: Chest pain, asthenia^[Ref]

Cardiovascular

The degree of hypertension was moderate and it is not certain as to whether it was due to a direct effect of carboprost or a return to a status of pregnancy associated hypertension manifested by the correction of hypovolemic shock.^[Ref]

Common (1% to 10%): Flushing, hot flushing, chills

Uncommon (0.1% to 1%): Septic shock, tachycardia

Frequency not reported: Hypertension, shivering

Postmarketing reports: Palpitations^[Ref]

Genitourinary

When carboprost was used for abortion, the most common complications which required additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding which was reported to have occurred in approximately 2% of patients.^[Ref]

Common (1% to 10%): Endometritis, uterine hemorrhage, retained placenta or membranes

Uncommon (0.1% to 1%): Urinary tract infection, uterine rupture, uterine cervical laceration, pelvic pain

Frequency not reported: Dysmenorrhea-like pain, uterine disorder, perforated uterus, uterine sacculation, uterine rupture^[Ref]

Nervous system

Common (1% to 10%): Headaches

Uncommon (0.1% to 1%): Syncope vasovagal, dizziness, dystonia, paresthesia, somnolence, dysgeusia, lethargy

Frequency not reported: Drowsiness, faintness, lightheadedness

Postmarketing reports: Nervousness, syncope^[Ref]

Respiratory

Common (1% to 10%): Cough

Uncommon (0.1% to 1%): Asthma, respiratory distress, dyspnea, hyperventilation, wheezing, hiccups

Frequency not reported: Nosebleed, bronchospasm, pharyngeal edema, upper respiratory tract infection, pulmonary edema, shortness of breath, fullness of throat

Postmarketing reports: Chocking sensation, epistaxis, dry throat^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Hyperhidrosis

Frequency not reported: Diaphoresis

Postmarketing reports: Rash^[Ref]

Local

Uncommon (0.1% to 1%): Injection side pain^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Torticollis, back pain, myalgia

Frequency not reported: Breast tenderness, muscular pain, muscle spasms, leg cramps

Postmarketing reports: Blepharospasm^[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, eye pain

Frequency not reported: Twitching eyelids^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Sleep disorders

Postmarketing reports: Anxiety^[Ref]

Endocrine

Frequency not reported: Thyroid storm

Postmarketing reports: Thyrotoxic crisis^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reactions, anaphylactic shock, anaphylactoid reaction, angioedema^[Ref]