Applies to teriparatide: subcutaneous solution.
Serious side effects of Teriparatide
Along with its needed effects, teriparatide 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 teriparatide:
More common
- Confusion
- constipation
- depression
- dry mouth
- headache
- incoherent speech
- increased urination
- loss of appetite
- metallic taste
- muscle weakness
- nausea
- stomach pain
- thirst
- unusual tiredness
- vomiting
- weight loss
Less common
- Arm, back, or jaw pain
- chest pain, discomfort, tightness, or heaviness
- cough
- fainting
- fast or irregular heartbeat
- fever or chills
- nausea
- sneezing
- sore throat
- sweating
- trouble breathing
Incidence not known
- Hives or welts, itching, skin rash
- redness of the skin
- swelling or puffiness of the mouth and face
Other side effects of Teriparatide
Some side effects of teriparatide 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
- Acid or sour stomach
- belching
- blurred vision
- body aches or pain
- diarrhea
- difficulty having a bowel movement (stool)
- difficulty with moving
- dizziness
- heartburn
- hoarseness
- indigestion
- lack or loss of strength
- muscle pain, stiffness, or spasm
- nervousness
- pain in the joints
- pounding in the ears
- runny or stuffy nose
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
Less common
- Back pain
- discomfort
- discouragement
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of constant movement of self or surroundings
- feeling sad or empty
- indigestion
- irritability
- lack of appetite
- leg cramps
- loss of interest or pleasure
- neck pain
- sensation of spinning
- sleeplessness
- stomach cramps
- swollen mouth and tongue
- tiredness
- tooth disorder
- trouble concentrating
- trouble sleeping
- unpleasant taste
- urge to have bowel movement
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- flushing
- unusually warm skin
For Healthcare Professionals
Applies to teriparatide: subcutaneous solution.
General
The more commonly reported side effects have included arthralgia, pain, and nausea.
Hypersensitivity
Rare (less than 0.1%): Anaphylaxis, possible allergic events soon after injection (e.g., acute dyspnea, oro/facial edema, generalized urticaria, chest pain, edema (mainly peripheral)
Postmarketing reports: Drug hypersensitivity, angioedema, urticaria[Ref]
Oncologic
Frequency not reported: Osteosarcoma[Ref]
Cases of bone tumor and osteosarcoma have been reported during the postmarketing period; however, an increased risk of osteosarcoma was not observed in observational studies. Two osteosarcoma surveillance safety studies (US claims-based database studies) designed to assess the incidence rate of osteosarcoma showed 3 osteosarcoma cases among 379,283 patients and zero cases among 153,316 patients receiving this drug. A similar risk for osteosarcoma has been observed with comparators. The interpretation of these results suggests caution as data sources do not allow for complete measurement and control for confounders.[Ref]
Genitourinary
Frequency not reported: Urolithiasis
Cardiovascular
Common (1% to 10%): Hypotension, hypertension, palpitations, chest pain, angina pectoris
Uncommon (0.1% to 1%): Tachycardia, cardiac murmur
Frequency not reported: Peripheral edema[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, hiatus hernia, gastro-esophageal reflux disease, constipation, diarrhea, dyspepsia, gastrointestinal disorder, tooth disorder
Uncommon (0.1% to 1%): Hemorrhoids[Ref]
Musculoskeletal
Very common (10% or more): Pain in limb, arthralgia (10%)
Common (1% to 10%): Muscle cramps, neck pain, leg cramps
Uncommon (0.1% to 1%): Myalgia, arthralgia, back cramp/pain
Postmarketing reports: Muscle spasms of the leg or back[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache, sciatica, syncope[Ref]
Respiratory
Common (1% to 10%): Dyspnea, rhinitis, cough increased, pharyngitis, pneumonia
Uncommon (0.1% to 1%): Emphysema[Ref]
Dermatologic
Common (1% to 10%): Rash, sweating increased[Ref]
Endocrine
Frequency not reported: Transient hypoparathyroidism[Ref]
Hematologic
Common (1% to 10%): Anemia[Ref]
Local
Common (1% to 10%): Mild and transient injection site events (e.g., pain, swelling, erythema, localized bruising, pruritus, minor bleeding at injection site)
Uncommon (0.1% to 1%): Injection site erythema, injection site reaction[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia
Uncommon (0.1% to 1%): Hypercalcemia (greater than 2.76 mmol/L), hyperuricemia, weight gain, alkaline phosphatase increase
Postmarketing reports: Calciphylaxis, worsening of previously stable cutaneous calcification[Ref]
Other
Very common (10% or more): Pain (21%)
Common (1% to 10%): Vertigo, fatigue, asthenia, syncope[Ref]
Psychiatric
Common (1% to 10%): Depression, insomnia[Ref]
Renal
Uncommon (0.1% to 1%): Urinary incontinence, polyuria, micturition urgency, nephrolithiasis
Rare (less than 0.1%): Renal failure/impairment[Ref]
