BY :

Antira Anisahati, S.Farm., Apt.

adalah efek yang tidak diinginkan dan muncul
pada dosis terapi dan tidak selalu timbul pada
setiap pasien. Efek samping perlu diketahui
agar pengobatan tidak serta merta dihentikan
karena ketidaknyamanan akibat efek samping.
 All Drugs are No Drugs are
Dangerous Dangerous if
used properly

Some drugs Some drugs have a

have a low low incidence of
therapeutic ratio horrendous effects

Some drugs are

The most
dangerous in
dangerous drugs
acute poisoning
have the greatest
but not when
GOOD potential for
used BAD
benefit
therapeutically
Some adverse
Some adverse effects can be
effects occur predicted if you
How dangerous a drug is
after a delay or know the
depends on the skill of the
after stopping pharmacology
prescriber
(Type A); some
are not (Type B)
 The Risk to Benefit Ratio

When prescribing drugs a doctor must assess

risk to benefit ratio in the individual patient by
•Choosing an appropriate class of drug then an
appropriate individual agent
RISK BENEFIT •Is it effective ?
•What are the chances of adverse effect ?
•Are there features in this patient which
affect choice eg other drugs, organ failure,
aged
•Tailoring the dose
•Considering duration of treatment
 Setiap obat mempunyai efek samping
 Faktor yang berkontribusi :
◦ Umur
◦ Berat badan
◦ Jenis kelamin
◦ Kondisi kesehatan
◦ Keseriusan penyakit
 Pemakaian suatu obat harus dilakukan secara
hati-hati pada kondisi tertentu karena dapat
terjadi efek atau keadaan yang tidak
diinginkan oleh pasien.
 Misalnya, peringatan pemakaian pada kondisi
pasien gagal ginjal, hamil atau menyusui atau
riwayat alergi.
 Selain itu, termasuk peringatan pemakaian
obat secara bersamaan atau simultan dengan
obat lain.
 Jika muncul efek samping obat yang tidak
diinginkan maka :
◦ Mengganti obat baru
◦ Mengganti dosis
◦ Menghentikan penggunaan obat
◦ Cari bantuan tenaga medis yang kompeten
◦ Cari dokumen efek samping dan patient
medication report
 Mual
 Muntah
 Fatigue(kelelahan)
 Pusing
 Mulut kering
 Sakit kepala
 Gatal, kemerahan
 Nyeri otot
 Abdominal Pain
 Blurred Vision  Heart Palpitations
 Constipation  Coordination
 Diarrhea Problems
 Dizziness  Ringing in the Ears
 Headaches  Skin Rashes or Hives
 Loss of Appetite  Swelling of Hands or
 Memory Loss Feet
 Loss of Consciousness
or Fainting
Types of Adverse Drug Reactions (A-B-C-D-E):

Type A: Augmented pharmacologic effects - dose

dependent and predictable (e.g. hypoglycaemia with
insulin, bleeding after anticoagulants, drowsiness
after opioids)

They are common but often not severe, they are usually
caused by too high dosage or alered pharmacokinetics
(genetic factors, age, reduced renal or hepatal
elimination)

Type B: Bizarre effects (or idiosyncratic) - dose

independent and unpredictable are relatively rare and
may occur with very low doses (e.g. drug allergy – skin
rashes – anaphylaxis)
Types of Adverse Drug Reactions (A-B-C-D-E):

Type C: Chronic effects after chronic administration

(e.g. analgesic nephropathy after some analgesics or
tardive dyskinesia after antipsychotics)

Type D: Delayed effects (e.g. teratogenic effects –

thalidomide , cancerogenic effects – stilbestrol during
pregnancy > vaginal carcinoma in daughters
20+years later)

Type E: End-of-treatment effects (e.g. withdrawal

effects corticosteroid)
 Examples of adverse effects associated
with specific medications

Bleeding in GIT NSAIDs

Thrombosis hormonal contraceptives

Ototoxicity, aminoglycoside antibiotics

nephrotoxicity
Parkinsonism 1st generation (typical) antipsychotics

Aplastic anaemia chloramphenicol

Agranulocytosis clozapine (atypical antipsychotic)

Hair loss anticancer drugs

 Frequency of adverse drug reactions

• Very common (>10%) >= 1/10

• Common (frequent) (1-10%) > = 1/100 and < 1/10

• Uncommon (infrequent) (0,1 - 1 %) >= 1/1000 and < 1/100

• Rare (0,001-0,1%) >= 1/10000 and < 1/1000

• Very rare (< 0,001 %) < 1/10000

 Ginjal
1. Parasetamol, NSAID, Aminoglikosida
 NEFROTOKSIS
2. Cyclosporin nefropati
 Darah
1. Kloramfenikol, allopurinol, cimetidine,
tetrasiklin, diklofenak  aplastik anemia
2. Omeprazole, fenitoin, carbamazepin,
phenobarbital  anemia megaloblastik
 Saraf
1. IsoniazidDefisit sensoris, ataxia
2. Metronidazolegangguan sensoris, ataxia
3. Amfetamineeuforia, ketergantungan
 Hati
1. Acetaminophen, ethanol  Kematian sel
2. Chlorpromazine, estrogen Canalicular
cholestasis
3. Amoxicillin  Kerusakan saluran empedu
4. Vit A, etanol  Sirosis
 Carilah efek samping dari NSAID,
antihipertensi, anti koagulan, anti histamin,
kortikosteroid, antibiotik, diuretik dan insulin
(masing-masing 3)!